Previous Studies

Interested in learning more about our past and current studies? Just click on the list of studies to the right and you will find a synopsis of the selected study below.

Diabetes – Type 2

2018 – PI – Ronald Brazg, MD (Phase 3)

A 52-Week, Randomized, Double Blind, Double Dummy, Active and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of An Investigational Medication Compared to Glimepiride or Placebo Added to Metformin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy.

2017 – PI – Ronald Brazg, MD (Phase 3)

A Randomized, Double Blind, Placebo Controlled, 3-Arm, Parallel Group, 52-Week Multicenter Study to Evaluate the Efficacy and Safety of An Investigational Medication in Patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control.

2017 – PI – Ronald Brazg, MD (Phase 3)

An Open Label, Randomized, Multicenter, Phase III Study Compare the Immunogenicity, Efficacy, And Safety of A Biosimilar Insulin Glargine Injection to Lantus (Insulin Glargine Injection) In Adult Subjects with Type 2 Diabetes Mellitus.

2017 – PI – Ronald Brazg, MD (Phase 3)

Six Month, Randomized, Open Label, Parallel Group Comparison of An Investigational Insulin to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, With a 6-Month Safety Extension Period.

2017 – PI – Leslie Klaff, MD, Ph.D (Phase 3)

A Prospective, Randomized, Double-Blind Comparison of An Investigational Insulin to Insulin Lispro, Both in Combination with Insulin Glargine or Insulin Degludec in Adults with Type 2 Diabetes.

2017 – PI – Leslie Klaff, MD, Ph.D

Dynamic Responsiveness of Insulin Secretory Parameters to Sitagliptin and Glimepiride Administration in Subjects with Type 2 Diabetes Mellitus: An Open Label Study.

2016 – PI – Leslie Klaff, MD, Ph.D (Phase 2)

A Phase 2, Double Blind, Pacebo Controlled, 18 Week Trial of Investigational GLP-1 Doses Versus Placebo in Patients with Type 2 Diabetes on Metformin Monotherapy.

2016 – PI – Leslie Klaff, MD, Ph.D (Phase 3a)

Flexible Dose Adjustment. Efficacy and Safety of an Investigational Oral GLP-1 Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.

2016 – PI – Ronald Brazg, MD  (Phase 4)

A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of Two Marketed and Approved Insulins in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with Oral Antidiabetic Drug(s) ± GLP-1 receptor agonist

2016 – PI – Leslie Klaff, MD, Ph.D  (Phase 3a)

Efficacy and Long-Term Safety of An Investigational Oral Medication Versus Sitagliptin in Subjects With Type 2 Diabetes.

2015 – PI – Leslie Klaff, MD, Ph.D  (Phase 3b)

Safety and Efficacy of An Approved Insulin Administered by Continuous Subcutaneuous Insulin Infusion Versus Multiple Daily Injections in Subjects with Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial.

2015 – PI – Ronald Brazg, MD  (Phase 2a)

Phase 2a Multicenter, Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of An Investigational Medication Injection in Adult Subjects with Type 2 Diabetes Mellitus.

2015 – PI – Allen Sussman, MD  (Phase 2)

Dose-Finding of An Investigational Medication Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes: A 26-week, Multicentre, Double-Blind, Randomised, Controlled Dose-Finding Trial.

2015 – PI – Ronald Brazg, MD  (Phase 2)

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Multiple Oral Bedtime Doses of An Investigational Insulin in Adult Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled with Diet and Metformin.

2015 – PI – Ronald Brazg,MD  (Phase 3)

Glycemic Control and Treatment Satisfaction Using An Insulin Delivery System Versus Pen for Initiating Bolus Insulin Dosing in Patients with Type 2 Diabetes Mellitus (T2DM) Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents (AHAs).

2015 – PI – Leslie Klaff, MD, Ph.D (Phase 2b)

A Randomized, Open-Label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of An Investigational Insulin Compared to Humalog Mix 75/25 in Subjects With Type 2 Diabetes.

2015 – PI – Leslie Klaff, MD, Ph.D (Phase 2b)

A Randomized, Open-Label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of An Investigational Insulin Compared to Humalog Mix 75/25 in Subjects With Type 2 Diabetes.

2015 – PI – Ronald Brazg, MD (Phase 4)

Effect of An Approved Oral Diabetes Medication On 24-Hour Blood Glucose in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Either Metformin Or Insulin.

2015 – PI – Ronald Brazg, MD (Phase 3)

Six-Month, Randomized, Open-label, Parallel-Group Comparison of An Investigational Insulin Analog to Humalog in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine.

2015 –PI – Leslie Klaff, MD, Ph.D (Phase 3)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension to Evaluate the Efficacy and Safety of An Approved Oral Diabetes Medication in Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy.

2014 –PI – Ronald Brazg, MD (Phase 3)

A Randomized, 30 Week, Active-Controlled, Open-Label, 3-Treatment Arm, Parallel-Group Multicenter Study Comparing the Efficacy and Safety of An Investigational Insulin Fixed Ratio Combination to Insulin Glargine Alone and to An Approved Diabetes Medication Alone on Top of Metformin in Patients with Type 2 Diabetes Mellitus. (T2DM).

2014 –PI – Ronald Brazg, MD (Phase 2a)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of An Investigational Medication Given as Monotherapy to Adults with Type 2 Diabetes Mellitus.

2014 –PI – Ronald Brazg, MD (Phase 2)

A Phase II, 12-Week, Double-Blind, Randomised, Parallel Group, Multi-Centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of An Investigational Medication Versus Placebo or Open-Label Liraglutide in Subjects with Type 2 Diabetes.

2014 –PI – Leslie Klaff, MD, Ph.D (Phase 3b)

An Approved Medication + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus.

2014 –PI – Leslie Klaff, MD, Ph.D (Phase 3b)

An Approved Medication Versus Placebo as Add-on to Intensified Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus.

2014 –PI – Leslie Klaff, MD, Ph.D (Phase 3)

A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center study to Compare the Efficacy, Safety, and Tolerability of An Investigational Medication to Sitagliptin as Add-on Therapy to Metformin in Patients with Type 2 Diabetes.

2014 –PI – Leslie Klaff, MD, Ph.D (Phase 3)

A Randomized, Double-Blind Trial Comparing the Effect of An Approved Diabetes Medication with Placebo On Glycemic Control in Patients with Type 2 Diabetes on Basal Insulin Glargine.

2014 –PI – Allen Sussman, MD (Phase 3)

Efficacy and Safety of An Investigational Medication Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-Naïve Subjects with Type 2 Diabetes.

2013 – PI – Ronald Brazg, MD (Phase 4)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Blood Pressure Reduction with Ambulatory Blood Pressure Monitoring (ABPM), Safety, and Tolerability of An Approved Diabetes Medication in Treatment of Subjects with Hypertension and Type 2 Diabetes Mellitus.

2013 –PI – Ronald Brazg, MD (Phase 2)

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of An Investigational Medication in Subjects with Type 2 Diabetes Mellitus

2013 –PI – Leslie Klaff, MD, Ph.D (Phase 4)

Two Treatment Approaches for An Approved Insulin (Thrice-Daily versus Twice-Daily) in Subjects with Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy with or without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial

2013 – PI – Leslie Klaff, MD, Ph.D (Phase 3b)

A Trial Comparing the Efficacy and Safety of An Investigational Insulin Combination Versus Insulin Glargine in Subjects with Type 2 Diabetes Mellitus.

2013 –PI – Leslie Klaff, MD, Ph.D (Phase 3)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of An Implanted Device That Administers an Approved Diabetes Medication in Patients with Type 2 Diabetes

2013 – PI – Allen Sussman, MD (Phase 3b)

A Randomized, Double Blind, Cross-Over Trial Comparing the Safety and Efficacy of An Investigational Insulin and Insulin Glargine Both in Combination with Metformin in Subjects with Type 2 Diabetes.

2013 –PI – Allen Sussman, MD (Phase 2)

A Double-Blind, Placebo Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of An Investigational Medication Administered Once Weekly By Subcutaneous Injection to Patients With Type 2 Diabetes Mellitus Being Treated with Metformin

2013 – PI – Ronald Brazg, MD

Pharmacokinetics of Insulin Lispro to Investigate Novel Insulin on Board Calculations

2012 – PI – Ronald Brazg, MD (Phase 3)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition to Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin

2012 –PI – Ronald Brazg, MD (Phase 2b)

Phase 2b Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Parallel-Group Study to Assess the Pharmacodynamics Response and Safety and Tolerability of Three Dose Levels of An Investigation Medication Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus

2012 – PI – Ronald Brazg, MD (Phase 2a)

A Randomized, 24-Week, Open-Label, 2-Arm Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of A Combination of Two Marketed Drugs Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

2012 – PI – Leslie Klaff, MD, Ph.D (Phase 3)

The Impact of An Investigational Medication Versus Insulin Glargine for Patients with Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin with Preprandial Insulin Lispro: a Double-Blind, Randomized, 26 Week Study

2012 –PI – Allen Sussman, MD (Phase 3)

A Phase 3, Multi-Center, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Efficacy and Safety of An Investigational Inhaled Prandial Insulin Versus Investigational Inhaled Insulin (Placebo) in Insulin Naïve Subjects with Type 2 Diabetes Mellitus Poorly Controlled with Oral Antidiabetic Agents Over a 24-week Treatment Period.

2012 – PI – Leslie Klaff, MD, Ph.D (Phase 3b)

The Effect of a Marketed GLP-1 Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects with Type 2 Diabetes.

2012 –  PI – Allen Sussman, MD (Phase 3)

Six-Month, Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of a New Formulation of A Marketed Basal Insulin and Lantus in Insulin-Naïve Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Non-Insulin Anti-hyperglycemic Drugs with a 6-month Safety Extension Period.

2011 –PI – Leslie Klaff, MD, Ph.D (Phase 2)

A Phase 2, Multicenter, Randomized, Double Blind, Parallel Group, Placebo-Controlled Study of An Investigational Medication in Subjects With Type 2 Diabetes and Inadequate Glycemic Control With Metformin Therapy

2011 –PI – Allen Sussman, MD (Phase 3b)

A Trial Comparing the Efficacy and Safety of An Investigational Insulin (200 U/mL) and An Investigational Insulin (100 U/mL) in Subjects with Type 2 Diabetes Mellitus

2011 –PI – Allen Sussman, MD (Phase 2)

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Safety and Efficacy Study of An Investigational Medication (10 mg and 25 mg administered orally once daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

2011 –PI – Allen Sussman, MD (Phase 2)

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase II Study of An Investigational Medication in Patients with Type 2 Diabetes Mellitus

2010 PI – Ronald Brazg, MD (Phase 3)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of An Investigational Medication Compared with Placebo in the Treatment of Older Subjects with Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy.

2010 PI – Leslie Klaff, MD, Ph.D (Phase 3)

The Impact of An Investigational Medication versus Insulin Glargine Both in Combination with Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus.

2010 PI – Leslie Klaff, MD, Ph.D (Phase 2)

A Phase 2 Study of An Investigational Medication Compared with Insulin Glargine in the Treatment of Type 2 Diabetes Mellitus.

2010 PI – Leslie Klaff, MD, Ph.D (Phase 2)

The Effect of An Investigational Medication on Blood Pressure and Heart Rate as Assessed by Ambulatory Blood Pressure Monitoring in Patients with Type 2 Diabetes Mellitus.

2010 PI – Allen Sussman, MD (Phase 2)

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety and Efficacy of An Investigational Medication in Subjects with Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

2010 PI- Leslie Klaff, MD, Ph.D (Phase 3a)

A Trial Comparing Efficacy and Safety of An Investigational Medication and Insulin Glargine in Subjects With Type 2 Diabetes

2010 –  PI – Ronald Brazg, MD (Phase 2)

A Phase IIb, Randomized, Place-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of An Investigational Medication in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

2009 PI – Allen Sussman, MD (Phase 4)

A 26 week randomized, multinational, open labeled, 2 armed, parallel group, treat-to-target once daily treatment trial with an approved insulin versus insulin glargine, both in combination with metformin in subjects with type 2 diabetes.

2009 PI – Allen Sussman, MD (Phase 3a)

A 52-Week Randomized, Controlled, Open Label, Multicentre, Multinational Treat-to-Target Trial Comparing Efficacy and Safety of An Investigational Insulin and Insulin Glargine Both Administered Once Daily in a Basal-Bolus Regimen with Insulin Aspart as Mealtime Insulin +/- Treatment with Metformin, +/- Pioglitazone in Subjects with Type 2 Diabetes Currently Treated with Insulin Qualifying for Intensified Treatment

2009 PI – Allen Sussman, MD (Phase 2a)

The Effects of An Investigational Nasal Insulin vs. Placebo on Blood Glucose Control in Patient Volunteers with Type 2 Diabetes Mellitus Currently Treated with Basal Insulin and Oral Antidiabetic Medications, Excluding Secretagogues, in a Phase IIa, Randomized, Parallel, Double Blind, Placebo Controlled, Multicenter Study

2009 PI – Ronald Brazg, MD

A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multi-Center Study to Evaluate the Safety and Efficacy of An Investigational Medication in Patients with Type 2 Diabetes Mellitus on Background Treatment with Glimepiride With or Without Metformin

2009 PI – Ronald Brazg, MD (Phase 2a)

A Phase 2a, Multicenter, Double-Blind, Randomized, Active Controlled, Parallel Arm Clinical Trial to Study the Efficacy and Safety of An Investigational Medication Compared to Sulfonylurea in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Therapy

2009 PI- Leslie Klaff, MD, Ph.D (Phase 3)

A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Long-Term Safety of An Investigational Medication Compared With Insulin in Subjects with Type 2 Diabetes Mellitus.

2009 PI- Leslie Klaff, MD, Ph.D (Phase 3)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of An Investigational Medication When Used in Combination with Pioglitazone with or without Metformin in Subjects with Type 2 Diabetes Mellitus.

2009 PI- Leslie Klaff, MD, Ph.D (Phase 3)

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of An Investigational Medication Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects with Type 2 Diabetes Mellitus.

2009 – PI – Leslie Klaff, MD, Ph.D (Phase 3)

A Phase III Randomized, Double-Blind, Placebo-Controlled, Parallel Group Efficacy and Safety Study of An Investigational Medication, Administered Orally Once Daily for at least 52 Weeks in Type 2 Diabetic Patients in Combination with Basal Insulin Therapy

2008 PI – Allen Sussman MD (Phase 3a)

A Multicentre, Randomised, Open Label, Crossover Study to Explore Effectiveness, Safety and Preference of a An Investigational Insulin Delivery Device vs. FlexPen in Subjects with Type 1 or Type 2 Diabetes

2008   PI – Ronald Brazg, MD (Phase 3)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter 12-Week Study Assessing the Efficacy and Safety of an investigational medication in Drug Naive Patients with Type 2 Diabetes

2008 PI – Ronald Brazg, MD (Phase 2b/3)

A Phase 2b/3, Multicenter, Randomized, Double Blind, Placebo Controlled, Dose Range Finding Clinical Trial of An Investigational Medication in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin

2008 PI – Ronald Brazg, MD (Phase 2a)

A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of an investigational medication in Combination with Sitagliptin or in Combination with Metformin in Patients with Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control

2008 PI – Ronald Brazg, MD (Phase 2a)

A Phase 2A, Randomized, Double-Blind, Comparator and Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of Two Dose Levels of An Investigational Medication in Type 2 Diabetic Patients

2008 PI – Ronald Brazg, MD (Phase 2a)

A Phase 2a, Multicenter, Double Blind, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of An Investigational Medication in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control

2008 PI – Ronald Brazg, MD (Phase 2)

A Randomized, Placebo-Controlled, 2-Arm Parallel-Group, Multicenter Study With a 24-Week Main Treatment Period and an Extension Assessing the Efficacy and Safety of An Investigational Medication in Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin.

2008   PI – Leslie Klaff, MD, Ph D (Phase 3)

A Randomized, Double-Blind, Active-Controlled Parallel Group Efficacy and Safety Study of an investigational medication (5.0 mg administered orally once daily) compared to glimperiride ( 1 to 4 mg once daily) over two years, in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy

2008   PI – Leslie Klaff, MD, Ph D (Phase 3)

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of an investigational medication at two Doses for 24 Weeks Treatment on the rate of Regeneration of Epidermal Nerve Fibers in Patients with Mild Diabetic Peripheral Neuropathy

2008   PI – Leslie Klaff, MD, Ph D (Phase 2b)

An 18-Week, Randomized, Double Blind, Multicenter, Comparator Study of Two Doses of An Oral Investigational Insulin and Placebo with Background Metformin Treatment in Patients with Type 2 Diabetes Mellitus

2008   PI – Leslie Klaff, MD, Ph D (Phase 2)

The Effect of Dose Titration of an investigational medication in Overweight and Obese Patients with Type 2 Diabetes Mellitus

2007 PI – Ronald Brazg, MD (Phase 2b)

A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of an Investigational Medication in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control.

2007 PI – Allen Sussman, MD (Phase 3)

A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for An Investigational Inhaled Insulin in Insulin-Naïve Patients with Type 2 Diabetes Mellitus.

2007 PI – Allen Sussman, MD (Phase 3)

A 16-Week Randomized, Open Labelled, Four-Armed, Treat-to-Target, Parallel-Group Trial Comparing Three Different Dosing Levels of An Investigational Insulin and Insulin Glargine Once Daily, All in Combination with Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

2007 – PI – Ronald Brazg, MD (Phase 3a)

Inhaled Mealtime Insulin with the AERx iDMS Plus Metformin & Glimepiride versus Rosiglitazone Plus Metformin & Glimepiride in Type 2 Diabetes: A 26-Week, Open Label, Multicentre, Randomized, Parallel Trial to Investigate Safety and Efficacy.

2007 – PI- Leslie Klaff, MD, Ph.D (Phase 3)

An Open Label, Multicenter, Randomized, Parallel Group Study Comparing the Efficacy and Safety of an Investigational Insulin and Regular Human Insulin in Patients with Type 2 Diabetes Mellitus.

2006 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallen-Group, Fixed-Dose Study Evaluating the Effect of One Dose of An Investigational Medication (20 mg/day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled with Insulin

2006 –PI – Allen Sussman, MD (Phase II)

A Multi-Center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmocokinetics of An Investigational Medication in Patients With Type 2 Diabetes Mellitus

2006 – PI – Allen Sussman, MD (Phase IIIb)

A Phase 3b, randomized, open-label, parallel group, multicenter trail assessing the efficacy of Exubera vs Lispro introduced into a Lantus based regimen in ssub optimallycontrolled patients with Type 2 Diabetes Mellitus

2006 – PI – Allen Sussman, MD (Phase IIIa)

Liraglutide Effect and Action in Diabetes (Lead 3): Effect on Glycemic Control of Liraglutide versus Glimepiride in Type 2 Diabetes [A Fifty-Two Week (with Fifty-Two Week Open-Label Extension), Double-Blinded, Multicenter, Randomized, Parallel Study to Investigate Safety and Efficacy]

2006 – PI – Allen Sussman, MD (Phase 3A)

A Prospective, Multicenter, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects with Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of An Investigational Insulin Vs. Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 24-Week Follow Up.

2006 – PI – Allen Sussman, MD (Phase 2)

A Pilot Study of the Efficacy and Safety of an Investigational Medication on Glycemic Control in Subjects with Type 2 Diabetes Treated Aggressively but not Controlled on Combination Antihyperglycemic Therapy with Metformin and/or Thiazolidinedione (TZD) and Insulin.

2006 – PI- Ronald Brazg, MD (Phase III)

A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients with Type 2 Diabetes Mellitus who have Inadequate Glycemic Control on Combination Therapy with Metformin and a PPAR? Agonist

2006 – PI- Ronald Brazg, MD (Phase IIa/b)

An Efficacy and Tolerability study An Investigational Medication in Patients with Type 2 Diabetes Mellitus who have Inadequate Glycemic Control

2006 – PI- Leslie Klaff, MD, Ph.D

The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine when added to Existing Oral Therapy in Patients with Type 2 Diabetes and Inadequate Glycemic Control.

2006 – PI- Leslie Klaff, MD, Ph.D (Phase IIb)

A randomized, double-blinded, placebo-controlled, five parallel group study investigating the efficacy and safety of An Investigational Medication (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks in drug naïve and treated patients with Type 2 diabetes with insufficient glycemic control ( study includes an open-label metformin treatment arm)

2005 – PI – Ronald Brazg, MD (Phase IIIb)

A 26 Week, Multi-center, Open-label, Parallel, 2:1 Randomized Treat-to-Target Trial Comparing Efficacy and Safety of an investigational medication Versus Insulin Glargine using a Basal-Bolus Regimen with Insulin Aspart as Mealtime Insulin in Subjects with Type 2 Diabetes

2005 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of An Investigational Medication to Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination with Metformin

2005 – PI – Ronald Brazg, MD (Phase III)

A Study to Assess the Efficacy and Tolerability of An Investigational Medication Co-Administered with Insulin in Patients with Type 2 Diabetes

2005 – PI – Leslie Klaff, MD, Ph.D. (Phase IIIb)

A Phase 3B Randomized, Open-Label, Comparator Controlled, Multicenter Study to Evaluate the Metabolic Effect of A Marketed Drug, Rosiglitazone, and A Marketed Drug Plus Rosiglitazone in Subjects with Type 2 Diabetes Mellitus Treated with Metformin

2005 –PI – Allen Sussman, MD (Phase IIIa)

Primary Outcomes Within a 2-Year Period In Subjects With Diabetes Mellitus Treated with An Inhaled Investigational Medication or Usual Antidiabetic Treatment and In Subjects With Abnormalities in Glucose Control

2005 –PI – Allen Sussman, MD (Phase IIb)

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 26-Week Dose-Response Study of an investigational medication with Active Comparator in Subjects with Type 2 Diabetes

2004 – PI – Ronald Brazg, MD. (Phase IIa)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of an investigational medication Monotherapy in Patients with Type 2 Diabetes Mellitus and Metabolic Syndrome

2004 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of an investigational medication to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

2004 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of an investigational medication to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

2004 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of an investigational medication to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy

2004 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of an investigational medication Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

2004 – PI – Ronald Brazg, MD (Phase II)

A Phase II Dose-Range Finding Study of an investigational medication in patients with Type 2 Diabetes.

2004 –PI – Leslie Klaff, MD, PhD (Phase IV)

Effects of Mixture Therapies on the Overall Glycemic Control of Patients with Type 2 Diabetes: A Comparison of an investigational medication to Once-Daily Insulin Glargine Plus Lispro

2004 – PI – Leslie Klaff, MD, PhD (Phase III)

A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 52 Weeks Treatment with an investigational medication to Metformin up to 1000 mg bid in Drug Naïve Patients with Type II Diabetes.

2004 –PI – Leslie Klaff, MD, PhD (Phase III)

Safety and Efficacy of an investigational medication in Patients with Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

2004 – PI – Leslie Klaff, MD, PhD (Phase III)

Standard Training versus Intensive Training for an investigational medication and device in Insulin-Naïve Patients with Type 2 Diabetes Mellitus

2004 –PI – Leslie Klaff, MD, PhD (Phase IIa))

A Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Twelve-Week Treatment with Two Different Doses of an investigational medication, in Patients with Type 2 Diabetes Mellitus Treatment With Metformin

2004 – PI – Leslie Klaff, MD, PhD (Phase II)

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety, and Tolerability of Pioglitazone HCL (Actos) in Combination With an investigational medication in Subjects With Type 2 Diabetes

2004 – PI – Allen Sussman, MD (Phase IIIb)

A Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of an investigational medication in Combination with Metformin and Pioglitazone to Metformin and Pioglitazone Alone in Insulin Naïve Subjects with Type 2 Diabetes

2004 – PI – Allen Sussman, MD (Phase III)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of an investigation medication in Type 2 Diabetics with Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination with Other Oral Anti-Diabetic Agents

2004 – PI – Allen Sussman (Phase III)

A Randomized, Double-Blind, Placebo-Controlled Trial to Assess Safety and Tolerability during Treatment of Type 2 Diabetes with Usual Diabetes Therapy and either investigational medication or Placebo

2004 – PI Allen Sussman (Phase III)

A 24-Week Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of an investigational Therapy When Added to Therapy of Patients with Type 2 Diabetes

2003 –PI – Ronald Brazg, MD (Phase IV)

Investigational Medication Titrate-To-Target: An observational study of the efficacy of an investigational medication in patients with Type 2 Diabetes Mellitus not achieving glycemic targets on OADs with/ without once daily basal insulin therapy.

2003 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of investigational medication to Patients with Type 2 Diabetes with Inadequate Glycemic Control on Metformin and Sulfonylurea Therapy in Combination with Simvastatin.

2003 – PI – Ronald Brazg, MD (Phase III)

A Double-Blind, Randomized, Active-Controlled investigational medication and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise

2003 – PI – Ronald Brazg, MD (Phase III)

Effect of an investigational medication compared with insulin glargine in patients with Type 2 Diabetes Also Using Combination Therapy with Sulfonylurea and Metformin.

2003 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of an investigational medication Added to Insulin in Patients With Inadequately Controlled Type 2 Diabetes Mellitus

2003 – PI – Ronald Brazg, MD (Phase III)

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of an investigational medication in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

2003 – PI – Ronald Brazg, MD (Phase IIa)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, cross-over Study With an investigational medication in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

2003 – PI – Leslie Klaff, MD, Ph.D (Phase IV)

Long-Term Effects of Insulin plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients with Type 2 Diabetes: A Comparison of Premeal investigational insulin to a Once-Daily Insulin Glargine

2003 – PI – Leslie Klaff, MD, Ph.D (Phase III)

An Open-Label Study of the Long Term Safety of an investigational medication Use in Patients with Type 1 or 2 Diabetes Mellitus

2003 – PI – Leslie Klaff, MD, Ph.D (Phase II)

The Efficacy and Safety of an investigational medication for the Treatment of Type 2 Diabetes

2003 – PI – Allen Sussman, MD (Phase III)

A Multicenter, Double-Blind, Randomized, Active-Controlled Parallel Study in Patients With Type 2 Diabetes to Evaluate the Cardiac and Metabolic Effects of an investigational medication

2003 –PI – Allen Sussman, MD (Phase III)

A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing an investigational medication vs. Avandia (rosiglitazone maleate) as Add-On Therapy vs. an investigational medication Substitution of Sulfonylurea in Patients with Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment.

2003 – PI – Allen Sussman, MD (Phase III)

A Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Trial of an investigational medication for Glycemic Control in Patients With Diabetes Mellitus Type 2 With and Without Metformin

2002 – PI – Leslie Klaff, MD, Ph.D. (Phase IV)

70/30 (biphasic insulin aspart 70/30) bid vs. (insulin glargine) : A Multicenter, Randomized, Open-Label, Parallel Group Study in Subjects with type 2 Diabetes Inadequately Treated with OAD therapy

2002 –PI – Leslie Klaff, MD, Ph.D. (Phase III)

A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of an investigational medication Given Two Times a Day in Subjects with Type 2 Diabetes Mellitus Treated With Sulfonylurea Alone

2002 –PI – Leslie Klaff, MD, Ph.D. (Phase III)

A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of an investigational medication Given Two Times a Day in Subjects with Type 2 Diabetes Mellitus Treated With Metformin Alone

2002 –PI – Allen Sussman, MD (Phase III)

Efficacy and Safety of an investigational medication Compared with Subcutaneous Human Insulin Therapy in Adult Subjects with Type 2 Diabetes Mellitus: A Two-year, Outpatient, Open-Label, Parallel-Group Comparative Trial

2002 –PI – Allen Sussman, MD (Phase II)

Dose Finding, Efficacy, and Safety of an investigational medication in Subjects with Type 2 Diabetes.

2002 PI – Ronald Brazg, MD

A Randomized, double-blind, dose ranging, dose comparison-controlled trial to determine the safety and efficacy of an investigational medication in subjects with Type 2 Diabetes.

2002 PI – Leslie Klaff MD

A study comparing safety and efficacy of three doses of an infused investigational medication to placebo given by continuous subcutaneous infusion in combination with Metformin and Sulfonylurea over 12 weeks in patients with Type 2 Diabetes Mellitus.

2001 PI – Ronald Brazg MD

A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of an Investigational Medication in Type 2 Diabetic Patients

2001 PI – Ronald Brazg MD

A multicenter, double-blind, randomized, placebo- and active-controlled, parallel study to evaluate the glucose and lipid-altering efficacy and safety of an investigational oral medication in patients with Type 2 Diabetes.

2001 PI – Ronald Brazg, MD

A Double-Blind, Randomized Study to Evaluate the Effect of An investigational Medication in Subjects With Type 2 diabetes Mellitus Who Have Inadequate Glycemic Control On Half-Maximum to Maximum of the Labeled Doses of Sulfonylurea Monotherapy

2001 PI – Ronald Brazg, MD

A 12-Week, Double Blind, Randomized, Placebo-Controlled, Multicenter Study of An Investigational Medication on Glucose Control In Patients with Type 2 Diabetes Mellitus Not Optimally Controlled on a Sulfonylurea

2001 PI – Leslie Klaff MD

Multicenter, Randomized, Double-Blind, Active Controlled Trial to compare the efficacy and safety of 104 weeks of nateglinide plus metformin vs. glyburide plus metformin in drug naïve subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

2001 PI – Leslie Klaff MD

Evaluation of diabetic retinopathy progression in subjects with type 2 diabetes mellitus treated with insulin.

2001 PI – Leslie Klaff MD

26 week, multinational, multicenter, controlled, open, 1:1 randomized, parallel clinical trial comparing investigational insulin with regular human insulin injected subcutaneously in subjects with Type 2 diabetes mellitus also using NPH insulin, and which will lead into a comparative 26 – week safety extension study.

2001 PI – Leslie Klaff, MD., PhD

Repaglinide vs. Nateglinide in Combination with Metformin: Comparative Efficacy and Safety: An Open Label, Randomized, Parallel Group, Multi-Center Study In the Treatment of Patients With Type 2 Diabetes Inadequately Controlled with Sulfonylurea or Metformin Monotherapy or Low-Dose Glucovance

2001 PI – Leslie Klaff, MD, Ph.D

A Comparison of Safety and Efficacy of An Investigational Insulin B.I.D. Injected Before vs. After Meals: A Multicenter, Randomized, Open-Label, cross-Over Design Study In Elderly Insulin-Treated Subjects With Type 2 Diabetes

2001 PI – Allen Sussman MD

Double-Blind, Randomized, Parallel Group Clinical Trial to Compare the Efficacy, Safety, and Tolerability of An Investigation Medication and Metformin Immediate Release Tablets in the Treatment of Type 2 Diabetes Mellitus

2001 PI – Allen Sussman, MD

Combination Therapy of Metformin With Once-Daily Evening Dose of An Investigational Insulin or Human Insulin NPH: Comparison of Safety and Efficacy in Subjects with Type 2 Diabetes Previously Inadequately Controlled With Monotherapy or Oral Combination Therapy With Metformin – A Randomized, Six-Month, Open-Label, Parallel Design Multicenter Trial

2000 PI – Ronald Brazg, MD

Repaglinide vs. Pioglitazone vs. the Combination In type 2 Diabetes Patients: A 24-Week, Randomized, Controlled Multicenter Trial

2000 PI – Ronald Brazg, MD

A Multicenter, Randomized, Open-Label, cross-over Trial in Insulin-Requiring (Type 1 and Type 2) Patients with Diabetes, Comparing the Injections With An Investigational Insulin Dosed With A Disposable Pen Delivery Device and Injections with Vial and Syringe

2000 PI – Ronald Brazg, MD

A Multicenter, Randomized, Open-Label, cross-over Trial in Insulin-Requiring (Type 1 and Type 2) Patients with Diabetes, Comparing the Injections With An Investigational Insulin Dosed With A Disposable Pen Delivery Device and Injections with Vial and Syringe

2000 PI – Ronald Brazg, MD

Repaglinide vs. Pioglitazone vs. the Combination In type 2 Diabetes Patients: A 24-Week, Randomized, Controlled Multicenter Trial

2000 PI – Leslie Klaff, MD, Ph.D

A Phase II Proof of Concept Trial on the Antidiabetic Properties of An Investigational Medication in Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study with Four Parallel Groups

2000 PI – Leslie Klaff, MD, Ph.D

The Safety and Efficacy of An Investigational Medication Versus Rosiglitazone: A One-Year, Randomized, Double Blind, Parallel Group, Active Comparator Study

2000 PI – Leslie Klaff, MD, Ph.D

The Safety and Efficacy of An Investigational Medication Versus Rosiglitazone: A One-Year, Randomized, Double Blind, Parallel Group, Active Comparator Study

2000 PI – Leslie Klaff, MD, Ph.D

A Phase II Proof of Concept Trial on the Antidiabetic Properties of An Investigational Medication in Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study with Four Parallel Groups

2000 PI – Leslie Klaff, MD, Ph.D.

Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia In Insulin Naïve Subjects With Type 2 Diabetes On Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin

2000 PI – Leslie Klaff, MD, Ph.D.

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Rosiglitazone Added on To A Background of An Investigational Medication in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin/Glyburide Therapy

2000 PI – Leslie Klaff, MD, Ph.D.

Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia In Insulin Naïve Subjects With Type 2 Diabetes On Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin

2000 PI – Leslie Klaff, MD, Ph.D.

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Rosiglitazone Added on To A Background of An Investigational Medication in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin/Glyburide Therapy

2000 PI – Allen Sussman, MD

The Effect of an Investigational Medication on HbA1c levels in Type 2 Diabetic Patients, A Double-Blind, Placebo-Controlled, Randomized, Multicenter Dose-Finding and Dose Frequency Study.

2000 PI – Allen Sussman, MD

Efficacy, Dose-Ranging, and Safety for An Investigational Medication in Type 2 Diabetic Subjects Inadequately Controlled on Diet, Metformin, or Sulfonylurea: A 24-Week Double-Blind, Randomized, Placebo-Controlled Study; Phase 2b

2000 PI – Allen Sussman, MD

A Dose-Finding, Efficacy, Safety and Pharmacokinetics of An Investigational Medication In Patients With Type 2 Diabetes

2000 PI – Allen Sussman, MD

A Dose-Finding, Efficacy, Safety and Pharmacokinetics of An Investigational Medication In Patients With Type 2 Diabetes

2000 PI – Allen Sussman, MD

The Effect of an Investigational Medication on HbA1c levels in Type 2 Diabetic Patients, A Double-Blind, Placebo-Controlled, Randomized, Multicenter Dose-Finding and Dose Frequency Study.

2000 PI – Allen Sussman, MD

Efficacy, Dose-Ranging, and Safety for An Investigational Medication in Type 2 Diabetic Subjects Inadequately Controlled on Diet, Metformin, or Sulfonylurea: A 24-Week Double-Blind, Randomized, Placebo-Controlled Study; Phase 2b

1999 PI – Ronald Brazg, MD

A Phase III, Randomized, Double-Blind, Active Control Trial to Evaluate the Safety and Efficacy of a Fixed Combination Metformin/Glyburide Product in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Maximum Dose Sulfonylurea Monotherapy

1999 PI – Ronald Brazg, MD

A Phase III, Randomized, Double-Blind, Active Control Trial to Evaluate the Safety and Efficacy of a Fixed Combination Metformin/Glyburide Product in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Maximum Dose Sulfonylurea Monotherapy

1999 PI – Leslie Klaff, MD

A Phase I-II Study of the Safety and Efficacy of Subcutaneous Administration of An Investigational Medication on Fasting Blood Glucose In Subjects With Type 2 Diabetes

1999 PI – Leslie Klaff, MD

A Phase I-II Study of the Safety and Efficacy of Subcutaneous Administration of An Investigational Medication on Fasting Blood Glucose In Subjects With Type 2 Diabetes

1999 PI – Leslie Klaff, MD, Ph.D

A Multicenter, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled, Clinical Evaluation of an Investigational Medication in Combination with Current Insulin Therapy for 26 Weeks Duration in Subjects with Type 2 Diabetes Mellitus Who are Inadequately Controlled with Insulin Alone

1999 PI – Leslie Klaff, MD, Ph.D.

A Multicenter, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled, Clinical Evaluation of an Investigational Medication in Combination with Current Insulin Therapy for 26 Weeks Duration in Subjects with Type 2 Diabetes Mellitus Who are Inadequately Controlled with Insulin Alone

1999 PI – Leslie J. Klaff, MD, Ph.D

A Phase I-II Study of the Safety and Efficacy of Subcutaneous Administration of an Investigational Medication on Fasting Blood Glucose in Subjects with Type 2 Diabetes

1999 PI – Leslie J. Klaff, MD, Ph.D.

A Phase I-II Study of the Safety and Efficacy of Subcutaneous Administration of an Investigational Medication on Fasting Blood Glucose in Subjects with Type 2 Diabetes

1999 PI – Allen Sussman, MD

A 2-year, Randomized, Double-Blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone Versus Placebo in Combination with Glipizide in Elderly Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Glipizide Therapy and Who Are Intolerant to Metformin or Have a Contraindication to Metformin

1999 PI – Allen Sussman, MD

Efficacy and Safety of Inhaled Human Insulin Therapy in Subjects with Type 2 Diabetes Mellitus Not Well Controlled with Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial

1999 PI – Allen Sussman, MD

Efficacy and Safety of Inhaled Compared with Subcutaneous Human Insulin Therapy in Subjects with Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Paralleled Comparative Trial

1999 PI – Allen Sussman, MD

A Double-Blind, Randomized Study of the Safety and Efficacy of a Combination of Metformin and 45mg of ACTOS (Pioglitazone HCI) Compared to a Combination of Metformin and 30mg of ACTOS (Pioglitazone HCI) in the Treatment of Patients with Type 2 (Non-Insulin Dependent) Diabetes Mellitus

1999 PI – Allen Sussman, MD

A 2-year, Randomized, Double-Blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone Versus Placebo in Combination with Glipizide in Elderly Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Glipizide Therapy and Who Are Intolerant to Metformin or Have a Contraindication to Metformin

1999 PI – Allen Sussman, MD

Efficacy and Safety of Inhaled Human Insulin Therapy in Subjects with Type 2 Diabetes Mellitus Not Well Controlled with Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial

1999 PI – Allen Sussman, MD

Efficacy and Safety of Inhaled Compared with Subcutaneous Human Insulin Therapy in Subjects with Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Paralleled Comparative Trial

1999 PI – Allen Sussman, MD

A Double-Blind, Randomized Study of the Safety and Efficacy of a Combination of Metformin and 45mg of ACTOS (Pioglitazone HCI) Compared to a Combination of Metformin and 30mg of ACTOS (Pioglitazone HCI) in the Treatment of Patients with Type 2 (Non-Insulin Dependent) Diabetes Mellitus

1998 PI – Ronald Brazg, MD

A Double-blind, Placebo-Controlled, Randomized Trial to Determine the Effects of a Range of Doses of Metformin Novel Oral Dose Form (biphasic tablet). Administered Either once or Twice a Day in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise.

1998 PI – Ronald Brazg, MD

A Double-blind, Placebo-Controlled, Randomized Trial to Determine the Effects of a Range of Doses of Metformin Novel Oral Dose Form (biphasic tablet). Administered Either once or Twice a Day in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise.

1998 PI – Leslie J. Klaff, MD, Ph.D.

A Double-blind, Randomized Study of the Effects of a Metformin Novel Oral Dosage Form in Patients with Type 2 Diabetes Who are Currently Treated with Immediate Release Metformin.

1998 PI – Leslie J. Klaff, MD, Ph.D.

A Double-blind, Randomized Study of the Effects of a Metformin Novel Oral Dosage Form in Patients with Type 2 Diabetes Who are Currently Treated with Immediate Release Metformin.

1998 PI – Allen Sussman, MD

A Randomized, Double-blind, Double-dummy Comparison of Sulfonylurea with a Titrated Dose of and Investigational Medication in Type 2 Diabetic Patients.

1998 PI – Allen Sussman, MD

A Randomized, Double-blind, Double-dummy Comparison of Sulfonylurea with a Titrated Dose of and Investigational Medication in Type 2 Diabetic Patients.

1997 PI – Ronald Brazg, MD

A Randomized, Double-blind, Placebo-Controlled, Six-Month Safety and Efficacy Trial of an Investigational Medication in Type II Diabetes Mellitus Patients.

1997 PI – Ronald Brazg, MD

A Randomized, Double-blind, Placebo-Controlled, Six-Month Safety and Efficacy Trial of an Investigational Medication in Type II Diabetes Mellitus Patients.

1997 PI – Ronald Brazg, MD

A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Metformin and an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.

1997 PI – Ronald Brazg, MD

A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Sulfonylurea and two doses of an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.

1997 PI – Ronald Brazg, MD

A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Insulin and Two Doses of an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.

1997 PI – Ronald Brazg, MD

A Randomized, Double-blind, Placebo-Controlled, Six-Month Safety and Efficacy Trial of an Investigational Medication in Type II Diabetes Mellitus Patients.

1997 PI – Ronald Brazg, MD

A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Metformin and an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.

1997 PI – Ronald Brazg, MD

A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Sulfonylurea and two doses of an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.

1997 PI – Ronald Brazg, MD

A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Insulin and Two Doses of an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.

1997 PI – Leslie J. Klaff, MD, Ph.D.

A 26 week Randomized, Double-blind, Multicentered, Study to Evaluate the Safety, Efficacy, and Tolerability of an Investigational Medication when administer to patients with Type II Diabetes Mellitus Patients who are inadequately controlled on insulin monotherapy.

1997 PI – Leslie J. Klaff, MD, Ph.D.

A 26 Week Randomized, Double blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of an Investigational Medication When Administered to Patients with Type II Diabetes Mellitus Who are Inadequately Controlled on a Maintenance Dose of Metformin.

1997 PI – Leslie J. Klaff, MD, Ph.D.

A 26 week Randomized, Double-blind, Multicentered, Study to Evaluate the Safety, Efficacy, and Tolerability of an Investigational Medication when administer to patients with Type II Diabetes Mellitus Patients who are inadequately controlled on insulin monotherapy.

1997 PI – Leslie J. Klaff, MD, Ph.D.

A 26 Week Randomized, Double blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of an Investigational Medication When Administered to Patients with Type II Diabetes Mellitus Who are Inadequately Controlled on a Maintenance Dose of Metformin.

1997 PI – Allen Sussman, MD

A 26 Week, Randomized, Double-blind, Multicenter, Placebo Controlled Study to Evaluate the Safety, Efficacy, and Tolerability of an Investigational Medication When Administered to Type II Diabetes Mellitus Using a Once Daily Dosing Regimen, and to Determine the Therapeutic Equivalence of the Once and Twice Daily Dosing Regimens.

1997 PI – Allen Sussman, MD

A 26 Week, Randomized, Double-blind, Multicenter, Placebo Controlled Study to Evaluate the Safety, Efficacy, and Tolerability of an Investigational Medication When Administered to Type II Diabetes Mellitus Using a Once Daily Dosing Regimen, and to Determine the Therapeutic Equivalence of the Once and Twice Daily Dosing Regimens.

1996 PI – Ronald Brazg, MD

A Randomized Double-blind, Placebo-Controlled, Six-Month Safety and Efficacy Trial of Investigational Medication in Type II Diabetes Mellitus Patients

1996 PI – Ronald Brazg, MD

A Randomized Double-blind, Placebo-Controlled, Six-Month Safety and Efficacy Trial of Investigational Medication in Type II Diabetes Mellitus Patients

1996 PI – Leslie Klaff, MD, Ph.D.

An Investigational Medication in Type II Diabetes: a Placebo Controlled, Double-blind, Randomized Six Month Fixed Dose Safety Study.

1996 PI – Leslie Klaff, MD, Ph.D.

A Multicenter, Double-blind, Randomized, Combination Study to Prospectively Evaluate the Safety and Efficacy of Two Oral Fixed Doses of an Investigational Medication Plus Glyburide Compared to Placebo Plus Glyburide in Subjects with Non-Insulin-Dependent Diabetes Mellitus on Sulfonylureas.

1996 PI – Leslie Klaff, MD, Ph.D.

An Investigational Medication in Type II Diabetes: a Placebo Controlled, Double-blind, Randomized Six Month Fixed Dose Safety Study.

1996 PI – Leslie Klaff, MD, Ph.D.

A Multicenter, Double-blind, Randomized, Combination Study to Prospectively Evaluate the Safety and Efficacy of Two Oral Fixed Doses of an Investigational Medication Plus Glyburide Compared to Placebo Plus Glyburide in Subjects with Non-Insulin-Dependent Diabetes Mellitus on Sulfonylureas.

1996 PI – Allen Sussman, MD

A 4-Year, Double-blind, Randomized, Placebo-Controlled Study of an Investigational Medication as Secondary Prevention of CHD in Patients with (Type II) Noninsulin- Dependent Diabetes Mellitus.

1996 PI – Allen Sussman, MD

A Multi-Center, Double-blind, Placebo-Controlled, Parallel Group Comparison Study to Investigate the Efficacy, Tolerability, and Safety of an Investigational Medication in the Treatment of Patients with Non-Insulin Dependent Diabetes Mellitus (Type II) Inadequately Controlled with Diet and Metformin.

1996 PI – Allen Sussman, MD

A Multi-Center, Double-blind, Placebo-Controlled, Parallel Group Comparison Study to Investigate the Efficacy, Tolerability, and Safety of an Investigational Medication in the Treatment of Patients with Non-Insulin Dependent Diabetes Mellitus (Type II) Inadequately Controlled with Diet and Metformin.

1996 PI – Allen Sussman, MD

A 4-Year, Double-blind, Randomized, Placebo-Controlled Study of an Investigational Medication as Secondary Prevention of CHD in Patients with (Type II) Noninsulin- Dependent Diabetes Mellitus.

1995-1996 PI – Ronald Brazg, MD

A Study to Evaluate the Safety and Efficacy of an Investigational Medication in the Treatment of Obese Type II Diabetics Maintained on Oral Hypoglycemic Agents.

1995-1996 PI – Ronald Brazg, MD

A 20 week, Double-blind, Randomized Study of an Investigational Medication in Patients With Non Insulin Dependent Diabetes.

1995-1996 PI – Ronald Brazg, MD

A 12 week, Double-blind Study of an Investigational Medication Versus Placebo in Noninsulin-dependent Diabetes Mellitus Patients Requiring Insulin.

1995-1996 PI – Ronald Brazg, MD

A Study to Evaluate the Safety and Efficacy of an Investigational Medication in the Treatment of Obese Type II Diabetics Maintained on Oral Hypoglycemic Agents.

1995-1996 PI – Ronald Brazg, MD

A 20 week, Double-blind, Randomized Study of an Investigational Medication in Patients With Non Insulin Dependent Diabetes.

1995-1996 PI – Ronald Brazg, MD

A 12 week, Double-blind Study of an Investigational Medication Versus Placebo in Noninsulin-dependent Diabetes Mellitus Patients Requiring Insulin.

1995-1996 PI – Leslie Klaff, MD

A Placebo-Controlled Safety and Efficacy Study of an Investigational Medication in Patients With Type II Diabetes Mellitus and Overt Diabetic Nephropathy.

1995-1996 PI – Leslie Klaff, MD

A Placebo-Controlled Safety and Efficacy Study of an Investigational Medication in Patients With Type II Diabetes Mellitus and Overt Diabetic Nephropathy.

1995-1996 PI – Allen Sussman, MD

Fifty-Two Week, Multicenter, Double-blind, Parallel Group, Placebo-Controlled and an Investigational Medication Dose Ranging Study to Evaluate Glycated Hemoglobin in Patients With Type II Diabetes Mellitus.

1995-1996 PI – Allen Sussman, MD

Fifty-Two Week, Multicenter, Double-blind, Parallel Group, Placebo-Controlled and an Investigational Medication Dose Ranging Study to Evaluate Glycated Hemoglobin in Patients With Type II Diabetes Mellitus.

1994-1996 PI – Allen Sussman, MD

A l-Year, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of an Investigational Medication in NIDDM Patients With Hyperlipidemia

1994-1996 PI – Allen Sussman, MD

A l-Year, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of an Investigational Medication in NIDDM Patients With Hyperlipidemia

1994-1995 PI – Allen Sussman, MD

A Multicenter, Double-blind, 26-Week Study Comparing the Efficacy and Safety of an Investigational Medication To Simvastatin in NIDDM Patients With Hyperlipidemia

1994-1995 PI – Allen Sussman, MD

A Multicenter, Double-blind, 26-Week Study Comparing the Efficacy and Safety of an Investigational Medication To Simvastatin in NIDDM Patients With Hyperlipidemia

1993-94 PI – Ronald Brazg, MD

A One Year, Multicenter-Center, Double-blind, Randomized, Parallel Group Comparison Extension Study To Investigate the Long-Term Efficacy, Tolerability and Safety of an Investigational Medication in Three Different Doses in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) who Have Satisfactorily Completed The Double-blind Treatment Phase of Study

1993-94 PI – Ronald Brazg, MD

A One Year, Multicenter-Center, Double-blind, Randomized, Parallel Group Comparison Extension Study To Investigate the Long-Term Efficacy, Tolerability and Safety of an Investigational Medication in Three Different Doses in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) who Have Satisfactorily Completed The Double-blind Treatment Phase of Study

1993 PI – Ronald Brazg, MD

A Multi-Center, Double-blind, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of an Investigational Medication in Three Different Doses in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) Inadequately Controlled With Maximum Daily Doses of Sulfonylurea and Diet

1993 PI – Ronald Brazg, MD

A Multi-Center, Double-blind, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of an Investigational Medication in Three Different Doses in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) Inadequately Controlled With Maximum Daily Doses of Sulfonylurea and Diet

1993 PI – Allen Sussman, MD

A One-Year, Multicenter, Double-blind, Randomized, Parallel Group Comparison Extension Study to Investigate the Long-Term Efficacy, Tolerability and Safety of an Investigational Medication As Compared to a Fixed Dose of Sulfonylurea, Alone and in Combination With an Investigational Medication, in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) who Have Satisfactorily Completed The Double-blind Treatment Phase of Study

1993 PI – Allen Sussman, MD

A One-Year, Multicenter, Double-blind, Randomized, Parallel Group Comparison Extension Study to Investigate the Long-Term Efficacy, Tolerability and Safety of an Investigational Medication As Compared to a Fixed Dose of Sulfonylurea, Alone and in Combination With an Investigational Medication, in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) who Have Satisfactorily Completed The Double-blind Treatment Phase of Study

1993 PI – Allen Sussman, MD

A Multi-Center, Double-blind, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of an Investigational Medication as Compared to a Fixed Dose of Sulfonylurea, Alone and in Combination With an Investigational Medication, in the Treatment of Patients With Mild Non-Insulin-Dependent Diabetes Mellitus (Type II) Inadequately Controlled With Diet Alone.

1993 PI – Allen Sussman, MD

A Multi-Center, Double-blind, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of an Investigational Medication as Compared to a Fixed Dose of Sulfonylurea, Alone and in Combination With an Investigational Medication, in the Treatment of Patients With Mild Non-Insulin-Dependent Diabetes Mellitus (Type II) Inadequately Controlled With Diet Alone.

1992-1993 PI – Leslie J. Klaff, MD, Ph.D

Randomized, Comparative Evaluation Of an investigational medication Combined With Insulin Versus Insulin Combined With Placebo In The Treatment of Patients With Non-Insulin Dependent Diabetes Mellitus.

1992-1993 PI – Leslie J. Klaff, MD, Ph.D

Randomized, Comparative Evaluation Of an investigational medication Combined With Insulin Versus Insulin Combined With Placebo In The Treatment of Patients With Non-Insulin Dependent Diabetes Mellitus.

1992-1993 PI – Leslie J. Klaff, MD, Ph.D.

Fifty-Six Week Open Label Study to Investigate the Long-Term Safety and Tolerability of an investigational medication in patients with Non-Insulin Dependent (Type II) Diabetes Mellitus, Treated With Diet Alone

1992-1993 PI – Leslie J. Klaff, MD, Ph.D.

A Multi-Center, Double-blind, Randomized, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of Three Different Doses of an Investigational Medication in Patients With Non-Insulin-Dependent (Type II) Diabetes Mellitus, Treated With Diet Alone

1992-1993 PI – Leslie J. Klaff, MD, Ph.D.

A Multi-Center, Double-blind, Randomized, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of Three Different Doses of an Investigational Medication in Patients With Non-Insulin-Dependent (Type II) Diabetes Mellitus, Treated With Diet Alone

1992-1993 PI – Leslie J. Klaff, MD, Ph.D.

Fifty-Six Week Open Label Study to Investigate the Long-Term Safety and Tolerability of an investigational medication in patients with Non-Insulin Dependent (Type II) Diabetes Mellitus, Treated With Diet Alone

1991-1994 PI – Allen Sussman, M.D.

Randomized, Comparative Evaluation Of The Efficacy and Safety Of an investigational medication Versus Glipizide in Patients With Non-Insulin Dependent Diabetes Mellitus

1991-1994 PI – Allen Sussman, M.D.

Randomized, Comparative Evaluation Of The Efficacy and Safety Of an investigational medication Versus Glipizide in Patients With Non-Insulin Dependent Diabetes Mellitus

Diabetes – Type 1

2018 – PI – Leslie Klaff, MD, Ph.D  (Phase 3b)

An Investigational Medication Compared to A Marketed Glucagon For Induced Hypoglycemia Rescue in Adults with Type 1 Diabetes: A Phase 3B Multi-centered, Randomized, Controlled, Single Blind, 2-Way Crossover Study to Evaluate Efficacy and Safety.

2017 – PI – Ronald Brazg, MD,  (Phase 3)

An Open-Label, Randomized, Multicenter, Phase III Study to Compare the Immunogenicity, Efficacy and Safety of A Biosimilar Insulin Glargine Injection to Lantus (Insulin Glargine Injection) in Adult Subjects with Type I Diabetes Mellitus.

2017 – PI – Leslie Klaff, MD, Ph.D  (Phase 3)

A Prospective, Randomized, Double Blind Comparison of An Investigational Insulin to Insulin Lispro With An Open-Label Postprandial Investigational Insulin Treatment Group in Combination with Insulin Glargine or Insulin Degludec in Adults with Type 1 Diabetes.

2017 – PI – Leslie Klaff, MD, Ph.D

Study Comparing Prandial Insulin Aspart vs Technosphere Insulin in Patients with Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real Life Pilot Study.

2017 – PI – Leslie Klaff, MD, Ph.D  (Phase 3)

An Investigational Glucagon Injection Compared to A Marketed Glucagon for Induced Hypoglycemia Rescue in Adult Patients with T1D. A Phase 3, Randomized, Blinded, 2-Way Crossover Study to Evluate Efficacy and Safety.

2016 – PI – Ronald Brazg, MD  (Phase 3b)

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of An Investigational FastActing Insulin compared to NovoRapid in Adults with Type 1 Diabetes.

2016 –PI – Ronald Brazg, MD  (Phase 2b)

A Phase 2b, Multicenter, Randomized, Double Blind, Titration Clinical Trial Evaluating the Efficacy and Safety of An Investigational Insulin Lispro in Combination with a Basal Insulin Versus Insulin Lispro in Combination with a Basal Insulin (Insulin Lispro, the Control Group), in Patients with Type 1 Diabetes Mellitus Over a 26-week Treatment Period.

2016 – PI – Ronald Brazg, MD  (Phase 4)

A Randomized, Active-Controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy And Safety Of The Morning Injection Of An Approved Basal Insulin Versus Lantus In Patients With Type 1 Diabetes Mellitus.

2016 – PI – Leslie Klaff, MD, Ph.D  (Phase 3a)

Efficacy and Safety of An Investigational Fast Acting Insulin Aspart Compared to NovoRapid Both in Combination With Insulin Degludec in Adults with Type 1 Diabetes.

2015 – PI – Leslie Klaff, MD, Ph.D  (Phase 3)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of An Investigational Medication as Adjunctive to Insulin Therapy Over 52 Weeks in Patients with Type 1 Diabetes Mellitus.

2015 –PI – Leslie Klaff, MD, Ph.D (Phase 3)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of An Investigational Medication as Adjunct Therapy in Adult Patients with Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control with Insulin Therapy.

2014 –PI – Leslie Klaff, MD, Ph.D (Phase 3)

An Open-Label, Randomized, Multicenter, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of An Investigational Insulin Glargine with Lantus in Type 1 Diabetes Mellitus Patients.

2014 –PI – Allen Sussman, MD (Phase 3a)

The Efficacy and Safety of An Approved Diabetes Medication Adjunct to Insulin Treatment in Type 1 Diabetes. A 26-Week Randomized, Insulin Capped, Placebo-Controlled, Double-Blind, Parallel Group, Multinational, Multicenter Trial.

2013 – PI – Ronald Brazg, MD (Phase 3a)

Efficacy and Safety of An Investigational Insulin Compared to Insulin Aspart Both in Combination with Insulin Detemir in Adults with Type 1 Diabetes.

2013 –PI – Leslie Klaff, MD, Ph.D (Phase 3b)

Evaluation of Metabolic Outcomes and Safety of An Investigational Compound Used as a Pre-Administration Infusion Site Treatment in Subjects with Type 1 Diabetes (T1DM) Using Continuous Subcutaneous Insulin Infusion (CSII)

2013 – PI – Leslie Klaff, MD, Ph.D (Phase 3)

A Phase III Clinical Trial to Study the Safety and Efficacy of An Investigational Insulin Compared to Lantus in Subjects With Type 1 Diabetes Mellitus.

2013 – PI – Allen Sussman, MD (Phase 3b)

A Randomized, Double Blind, Cross-Over Trial Comparing the Safety and Efficacy of An Investigational Insulin and Insulin Glargine, Both with Insulin Aspart as Mealtime Insulin in Subjects with Type 1 Diabetes.

2012 –PI – Ronald Brazg, MD (Phase 2)

A Randomized, Parallel Group Trial Evaluating Safety and Efficacy of An Investigational Insulin Compared to Insulin Lispro (Humalog) in Subjects with Type 1 Diabetes Using Basal-Bolus Insulin Injection Therapy

2012 –PI – Allen Sussman, MD (Phase 3)

Six-Month, Multicenter, Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of a New Formulation of A Marketed Basal Insulin and Lantus Injected in the Morning or Evening in Patients with Type 1 Diabetes Mellitus with a Six-Month Safety Extension Period.

2012 – PI – Leslie Klaff, MD, Ph.D (Phase 3)

The Impact of An Investigational Insulin Versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study

2012 – PI – Allen Sussman, MD (Phase 3)

A Phase 3, Multicenter, Open-Label, Randomized, Forced-Titration Clinical Trial Evaluating the Efficacy and Safety of An Investigational Insulin Inhalation Powder in Combination with a Basal Insulin Versus Insulin Aspart in Combination with a Basal Insulin in Subjects with Type 1 Diabetes Mellitus Over a 24-week Treatment Period.

2010 – PI – Leslie Klaff, MD, Ph.D (Phase IV)

Effects of A Marketed Glucose-Lowering Medication on Glucagon Suppression and GLP-1 Levels in Patients with Type 1 Diabetes

2010 – PI – Leslie Klaff, MD, Ph.D (Phase II)

A Phase 2 Study of An Investigational Medication Compared with Insulin Glargine in the Treatment of Type 1 Diabetes Mellitus

2009 -PI – Allen Sussman, MD (Phase IIIa)

A 52-Week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-Target Trial Comparing Efficacy and Safety of An Investigational Insulin and Insulin Glargine Both Administered Once Daily in a Basal-Bolus Regimen with Insulin Aspart as Mealtime Insulin in Subjects with Type 1 Diabetes

2007 – PI – Leslie Klaff, MD, Ph.D. (Phase III)

An Open Label, Multicenter, Randomized, Parallel Group Study Comparing the Efficacy and Safety of An Investigational Insulin and Regular Human Insulin in Patients with Type 1 Diabetes Mellitus

2007 PI – Ronald Brazg, MD (Phase III)

A 16-Week Randomized, Open Labeled, Three-Armed, Treat-to-Target, Parallel Group Trial Comparing Two Different Doses of An Investigational Insulin+NovoRapid and Insulin Glargine Once Daily+NovoRapid, All in a Basal/Bolus Regimen in Subjects with Type I Diabetes.

2006 – PI – Ronald Brazg, MD (Phase IIIa)

Inhaled Mealtime Insulin With the AERx®iDMS Versus Subcutaneous Injected Insulin Aspart Both In Combination With Insulin Detemir in Type 1 Diabetes: A 104-Week, Open-Label, Multicenter, Randomized, parallel Trial (Followed by a Twelve-Week Re-Randomized Extension) To Investigate Safety and Efficacy z

2006 – PI – Allen Sussman, M.D (Phase IIIa)

Pulmonary Outcomes within a 2-year period in Subjects with Diabetes Mellitus Treated with Technosphere®/Insulin or Usual Antidiabetic Treatment and in Subjects without Abnormalities in Glucose Control.

2005 – PI – Leslie Klaff, MD, Ph.D. (Phase III)

A Phase III Long-term Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients with Type 1 Diabetes Mellitus.

2003 – PI – Leslie Klaff, MD, Ph.D. (Phase II)

Safety and Efficacy of an investigational medication in Patients with Type 1 Diabetes Mellitus.

2002 –PI – Leslie Klaff, M.D., Ph.D. (Phase III)

A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of an investigational medication Treatment Employing investigational medication Dose-Titration Followed by Insulin Dose Optimization in Subjects with Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy.

2002 PI – Allen Sussman MD, Ph.D.

Safety of Novolog in CSH compared to basal/ bolus therapy with Novolog and Lantus in patients with type 1 diabetes previously treated with CSII; a randomized, cross-over trial.

2001 PI – Leslie J. Klaff MD, Ph.D.

12-week, multinational, multicenter, controlled, open, 1:1:1 randomized, parallel clinical trial to assess noninferiority between pre- and post-meal administration of an investigational insulin and pre-meal regular human insulin in subjects with type 1 diabetes mellitus receiving insulin glargine as the basal insulin therapy

2001 PI – Leslie J. Klaff MD, Ph.D.

A 26-Week, Multinational, Multicenter, Controlled Open, 1:1 Randomized, Parallel Clinical Trial Comparing An Investigational Insulin with Regular Human Insulin Injected Subcutaneously In Subjects With Type 2 Diabetes Mellitus Also Using NPH Insulin, and Which will Lead Into a Comparative 26-Week Safety Extension Study

2001 PI – Leslie J. Klaff MD, Ph.D.

A Randomized, Single-Blind, Controlled, Progressive, Dose-Escalation Study to Examine Dose Tolerability in Subjects with Type 1 Diabetes Mellitus Given An Investigational Medication Subcutaneously

1999 PI – Allen Sussman, M.D.

Efficacy and Safety of Inhaled Compared with Subcutaneous Human Insulin Therapy in Subjects with Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

1997 PI – Ronald Brazg, MD

A Randomized, Double-blind, Placebo-Controlled, Multicenter, Multi-dose Study of an Investigational Medication in Type I Diabetes Mellitus Patients.

1997 PI – Leslie J. Klaff, MD, Ph.D.

A 28 Week, Multicenter, Controlled, Randomized, Open Clinical Trial Comparing an Investigational Medication with NPH Insulin in Type I Diabetes Mellitus Patients.

1997 PI – Leslie J. Klaff, MD, Ph.D.

16-Week Multicenter, Controlled, Randomized, Open-Label Clinical Trial Comparing an Investigational Medication and NPH Human Insulin in Subjects with Type I Diabetes Treated with Insulin Lispro

1997 PI – Leslie J. Klaff, MD, Ph.D.

A Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Effects of an Investigational Medication on Glycemic Control as Determined by Glycated Hemoglobin in Type I Diabetes Mellitus Patients.

1996 PI – Allen Sussman, MD

A Long-Term, Multicenter Study to Evaluate the Tolerability of Investigational Medication in Patients With Type I Diabetes Mellitus.

1996 PI – Allen Sussman, MD

Comparison of Efficacy, Safety, and Tolerability of Two Formulations of an Investigational Medication in Comparison to NPH Insulin in Insulin Dependent Diabetes Mellitus (IDDM) Patients Receiving Basal Bolus Insulin Treatment.

1994-1995 PI – Allen Sussman, MD

A Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Continuous Subcutaneous Infusion and Preprandial Bolus Doses of an Investigational Medication or Placebo on Plasma Glucose Profiles in Juvenile-Onset Diabetes.

1994 PI – Leslie J. Klaff, MD, Ph.D.

A Double-blind, Randomized, Placebo Controlled, Dose Ranging Study to Assess the Tolerability, Pharmacokinetics, and Effects on a Hypoglycemic Challenge of Fourteen Days Multiple Dosing with an Investigational Medication in Subjects with Insulin Dependent Diabetes Mellitus.

Diabetic Complications

2016– PI – Leslie Klaff, MD, Ph D  (Phase 3)

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of An Investigational Medication in Subjects With Painful Diabetic Peripheral Neuropathy.

2015–PI – Allen Sussman, MD (Phase 2a)

A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of An Investigational Medication in Subjects with Painful Diabetic Peripheral Neuropathy.

2014–PI – Ronald Brazg, MD (Phase 2b)

A Multicenter Randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel-Group Study to Determine the Efficacy and Safety of An Investigational Topical Gel in the Treatment of Pain Associated with Painful Diabetic Neuropathy.

2014–PI – Ronald Brazg, MD (Phase 2)

A Randomized Double Blind Placebo and Active Controlled Parallel Group Phase 2 Study to Evaluate An Investigational Medication as a Monotherapy and as an Add-On to Pregabalin for the Treatment of Painful Diabetic Peripheral Neuropathy.

2013– PI – Allen Sussman, MD (Phase 2)

A Phase II Randomized, Double Blind, Parallel Group, Dose-Ranging, Placebo-Controlled Study to Assess the Safety and Effectiveness of An Investigational Medication in the Treatment of Subjects with Diabetic Neuropathy.

2013–PI – Leslie Klaff, MD, Ph D (Phase 2)

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of An Investigational Medication in Subjects with Painful Diabetic Peripheral Neuropathy

2012 –PI – Ronald Brazg, MD (Phase 2a)

A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of An Investigational Medication in Patients With Painful Diabetic Neuropathy

2012 –PI – Allen Sussman, MD (Phase 2)

A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of An Investigational Medication For Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

2011 – PI – Ronald Brazg, MD (Phase 2)

A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of An Investigational Medication to Placebo in Subjects with Diabetic Neuropathic Pain

2011 – PI – Leslie Klaff, MD, Ph D (Phase 3)

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of An Investigational Medication (10mg and 25mg administered once daily) As Add on to Pre-Existing Antidiabetic Therapy Over 52 Weeks in Patients with Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycemic Control

2010 – PI – Leslie Klaff, MD, Ph D (Phase 2b)

A Phase IIb Repeat Dosing Clinical Trial of An Investigational Medication in Subjects with Moderately Severe Diabetic Neuropathy

2009 PI – Leslie Klaff, MD, Ph.D (Phase 2b)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety,and Tolerability of An Investigational Medication in Subjects with Diabetic Peripheral Neuropathy, Followed by a Double-Blind Safety Extension and an Open-Label Safety Extension

2007 PI – Allen Sussman, MD (Phase II)

A Phase II Study of an Investigational Topical Medication for the Treatment of Symptomatic Diabetic Peripheral Neuropathy

2007   PI – Leslie Klaff, MD, Ph D (Phase 3)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine Whether, In Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, An FDA Approve Medication, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality

2007   PI – Leslie Klaff, MD, Ph D (Phase 2)

A Phase II Repeat Dosing Clinical Trial of An Investigational Medication in Subjects with Moderate to Severe Diabetic Neuropathy and Unmeasurable Nerve Conduction Velocity.

2007   PI – Leslie Klaff, MD, Ph D (Phase 2)

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of the Effect of An Investigational Medication At Two Doses for 24 Weeks Treatment on the Rate of Regeneration of Epidermal Nerve Fibers in Patients with Mild Diabetic Peripheral Neuropathy

2006   PI – Ronald Brazg, MD (Phase II)

A Phase II, Randomized, Double-Blinded, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20 mg, 40 mg and 80 mg of An Investigational Medication in Patients with Mild to Moderate Diabetic Polyneuropathy

2005 PI – Ronald Brazg, MD (Phase II)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 2 Study Designed to Assess the Efficacy and Safety of An Investigational Medication in Subjects with Painful Diabetic Neuropathy

2004   PI – Leslie Klaff, MD, PhD. (Phase III)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study of the Efficacy and Safety of an investigational medication in Patients With Diabetic Sensorimotor Polyneuropathy

2004   PI Ronald Brazg, MD (Phase II)

A Randomized, Double-Blind Placebo-Controlled, Flexible Dose Study of the efficacy and Safety of an investigational medication in Comparison to Gabapentin In Patients With Painful Diabetic Neuropathy

2003 PI – Ronald Brazg, MD (Phase IV)

A Multi-center, Double-blind, Randomized, Parallel Group Study to Evaluate the Effects of an investigational medication on Microalbuminuria in Hypertensive Subjects with Type 2 Diabetes Mellitus (DM)

2003 PI – Leslie Klaff, MD (Phase III)

Double-Blind Comparison of the efficacy and safety of an investigational medication versus Hydrochlorothiazide as add-on therapy to Ramipril 10 MG QD in Diabetic Hypertensive patients with Macroalbuminuria

2002 PI – Leslie Klaff, MD (Phase II)

An open – label dose escalation study of an investigational medication in patients with painful diabetic neuropathy.

2002 PI – Leslie Klaff, MD, Ph.D.

A randomized, double-blind, placebo-controlled, multi-center, 24-week study to evaluate the safety and tolerability of an investigational medication in patients with diabetic nephropathy associated with type 1 or type 2 diabetes.

2002 PI- Leslie Klaff, MD (Phase II)

A randomized, double-blind, placebo-controlled, multi-center, 24-week study to evaluate the safety and tolerability of an investigational medication in patients with diabetic nephropathy associated with type 1 or type 2 diabetes.

2001 PI – Leslie Klaff, MD, Ph.D

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of an Investigational Medication in Patients with Type 2 Diabetes and Diabetes-Associated Nephropathy

2001 PI – Leslie Klaff, MD, Ph.D

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of an Investigational Medication in Patients with Type 1 Diabetes and Diabetes-Associated Nephropathy

2001 PI – Leslie Klaff, MD, Ph.D.

Evaluation of the Safety and Efficacy of An Investigational Medication in the Treatment of Chronic Pain in Patients with Diabetic Neuropathy

2001 PI – Allen Sussman, MD.

A Multicenter, Efficacy and Safety Assessment of An Investigative Medication In Patients With Painful Diabetic Neuropathy

2000 PI – Ronald Brazg, MD

A Phase II Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of An Investigational Medication in Subjects with Diabetic Neuropathy

2000 PI – Leslie Klaff, MD, Ph.D

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of An Investigational Medication in Type 1 Diabetic Patients With Diabetes-Associated Nephropathy

1999 PI – Leslie Klaff, MD, Ph.D.

A Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of and Investigational Medication Versus Placebo in the Relief of Pain in Diabetic Peripheral Polyneuropathy

1999 PI – Leslie Klaff, MD, Ph.D.

A Multicenter, Blinded, Randomized, Placebo-Controlled Study of A Topical Gel in Patients With Painful Diabetic Neuropathy

1998 PI – Ronald Brazg, MD

A Phase II Randomized, Placebo-Controlled Dose-Ranging Trial of an Investigational Medication in Diabetic Patients with Painful Peripheral Neuropathy.

1996 PI – Leslie Klaff, MD, Ph.D.

A Multicenter, Double-blind, Placebo-Controlled, Parallel-Group Study of the Effects of an Oral Investigational Medication in Subjects With Peripheral Symmetrical Diabetic Polyneuropathy.

1993 PI – Ronald Brazg, MD

Randomized Study Comparing Two Dose Levels of an Investigational Medication and Vehicle For PC1020 Topical Gel in the Treatment of Diabetic Patients With Neuropathic Plantar Ulcers.

Diabetes Devices and Technology Studies

2018 – PI – Ronald Brazg, MD

A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of An Investigational Blood Glucose Monitoring Device (according to ISO 15197).

2018 – PI – Ronald Brazg, MD

An Investigational Sensor Based Glucose Monitoring System Characterization Study Using Capillary Glucose Reference.

2017 – PI – Ronald Brazg, MD

A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of An Investigational Blood Glucose Monitoring Device (according to ISO 15197).

2017 – PI – Ronald Brazg, MD

A Study to Evaluate the Functionality of An Investigational Automated Insulin Delivery (AID) System in Adult Patients with Type 1 Diabetes Mellitus.

2017 – PI – Leslie Klaff, MD, Ph.D

Precision of An Investigational Point of Care HbA1c Diagnostic Device in Fingerstick Samples.

2017 – PI – Ronald Brazg, MD

An Investigational Flash Glucose Monitoring System Accuracy Study.

2017 – PI – Ronald Brazg, MD

An Investigational Flash Glucose Monitoring System Accuracy Study.

2017 – PI – Ronald Brazg, MD

An Investigational Flash Glucose Monitoring System Accuracy Study.

2017 – PI – Leslie Klaff, MD, Ph.D

A Prospective, Multicenter Evaluation of Precision, Compression, Accuracy and Updated Algorithm of A Novel Continuous Implanted Glucose Sensor.

2017 – PI – Ronald Brazg, MD

Multicenter, Randomized, Parallel, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using An Investigational Hybrid Closed Loop System and Control (CSII, MDI and SAP) at Home.

2017 – PI – Ronald Brazg, MD

Study of An Investigational Device to Measure TSH Levels.

2017 – PI – Leslie Klaff, MD, Ph.D.

Evaluation of An Investigational Continuous Glucose Monitoring System with a Non-Interferent Sensor.

2016 – PI – Ronald Brazg, MD

A Sensor Based Glucose Monitoring System Characterization Study Using Capillary Glucose Reference.

2016 – PI – Leslie Klaff, MD, Ph.D.

Clinical Evaluation of the Accuracy of An Investigational Device to Measure Lipid Panels In A Point of Care Setting.

2016 – PI – Leslie Klaff, MD, Ph.D.

Effectiveness and Safety of An Investigational Continuous Glucose Monitoring System.

2016 – PI – Leslie Klaff, MD, Ph.D.

YSI Feasibility Study of An Investigational Continuous Glucose Monitoring (CGM) System In Non-Intensive Insulin Therapy Type 2 Diabetes Mellitus (T2DM) Adults.

2016 –PI – Leslie Klaff, MD, Ph.D.

YSI Feasibility Study of An Investigational Continuous Glucose Monitoring (CGM) System in Adults and Pediatrics with Diabetes Mellitus.

2016 –  PI – Ronald Brazg, MD

Design Verification/Validation of An Investigational Glucose Meter System and Test Strip Alternative Site Capillary Evaluation.

2016 – PI – Ronald Brazg, MD

Blood Glucose Monitor System Surveillance Program.

2016 – PI – Ronald Brazg, MD

Study of An Investigational Glucose Meter System and Test Strip Method Comparison/User Evaluation – US.

2016 – PI – Ronald Brazg, MD

Sensor Based Glucose Monitoring System Characterization Study Using Capillary Glucose Reference.

2016 – PI – Ronald Brazg, MD

Design Verification/Validation of An Investigational Glucose Meter and Test Strip Alternative Site Capillary Evaluation.

2015 – PI – Leslie Klaff, MD, Ph.D.

A Comparative, Controlled Study to Evaluate the Performance of An Investigational Glucose Meter Device.

2015 – PI – Leslie Klaff, MD, Ph.D.

A Prospective, Multicenter Evaluation of the Accuracy of a Novel Implanted Glucose Sensor.

2015 – PI – Allen Sussman, MD

Evaluation of Point of Care Lipid Testing Systems

2015 – PI – Ronald Brazg, MD

Study of an Investigational Glucose Meter System and Test Strip Method Comparison/User Evaluation – US.

2015 – PI – Ronald Brazg, MD

Safety Evaluation of An Investigational Closed Loop System in Type 1 Diabetes.

2015 – PI – Allen Sussman, MD

System Accuracy Evaluation of An Investigational Glucose Monitoring System in Non-Diabetic Subjects

2015 – PI – Ronald Brazg, MD

Sensor Based Glucose Monitoring System Characterization Study Using Capillary Glucose Reference

2015 – PI – Ronald Brazg, MD

Effectiveness and Safety Study of An Investigational Sensor Based Glucose Monitoring System – Personal and Professional Systems.

2015 – PI – Ronald Brazg, MD

A Sensor Based Glucose Monitoring System Characterization Study Using Capillary Glucose Reference.

2015 – PI – Ronald Brazg, MD

A Feasibility Study of A New Subcutaneous Glucose Sensor and Recorder.

2015 – PI – Ronald Brazg, MD

A Performance Evaluation of An Investigational Sensor to Support a Full 168 Hours (7 Days) of Use.

2015 – PI – Ronald Brazg, MD

Glucose Monitor Meter with the Glucose Monitor Test Strip Alternative Site Capillary Evaluation.

2015 – PI – Ronald Brazg, MD

In-Clinic Evaluation of An Investigational System in Adult and Pediatric Insulin Requiring Patients with Diabetes using An Investigational Sensor.

2014 –PI – Ronald Brazg, MD

A Performance Evaluation of the Two Investigational Glucose Sensors to Support a Full 144 hours (6 Days) of Use in Children.

2014 –PI – Ronald Brazg, MD

Feasibility Study of New Subcutaneous Glucose Sensor and Recorder.

2014 –PI – Ronald Brazg, MD

In-Clinic Feasibility Study to Observe An Investigational Overnight Closed Loop System.

2014 –PI – Ronald Brazg, MD

In-Clinic Evaluation of An Investigational Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients with Diabetes.

2014 –PI – Leslie Klaff, MD, Ph.D

Evaluation of the Accuracy of An Investigational Sensor Based Interstitial Glucose Monitoring System.

2014 –PI – Leslie Klaff, MD, Ph.D

User Performance of An Investigational Contour Blood Glucose Monitoring System.

2014 –PI – Leslie Klaff, MD, Ph.D

User Performance of An Investigational Blood Glucose Monitoring System.

2014 –PI – Leslie Klaff, MD, Ph.D

User Study for Evaluation of An Investigational HbA1c Point of Care Systems in a Waived Laboratory Setting.

2014 –PI – Leslie Klaff, MD, Ph.D

User Performance of An Investigational Blood Glucose Monitoring System.

2013 –PI – Ronald Brazg, MD

Pilot Evaluation of An Investigational Device on Healthy Volunteers Performing Exercise Testing.

2013 –PI – Ronald Brazg, MD

In-Clinic Feasibility Study to Observe An Investigational Overnight Closed Loop System

2013 –PI – Ronald Brazg, MD

An Investigational Glucose Monitoring System with An Investigational Test Strip Capillary Accuracy Testing

2013 –PI – Ronald Brazg, MD

User Performance Evaluation of Two Investigational Blood Glucose Monitoring Systems for Finger Blood Beta-Ketone and AST Blood Glucose Testing

2013 –PI – Leslie Klaff, MD, Ph.D

A Study of An Investigational Glucose Monitoring System with An Investigational Test Strip Alternative Site Capillary Evaluation.

2013 –PI – Leslie Klaff, MD, Ph.D

A Study of An Investigational Glucose Monitoring System With An Investigational Test Strip Alternative Site Capillary Evaluation.

2013 –PI – Leslie Klaff, MD, Ph.D

A Comparison of An Investigational Device for Lipid Profile Testing.

2013 –PI – Leslie Klaff, MD, Ph.D

Evaluation of the Accuracy of the An Investigational Sensor Based Interstitial Glucose Monitoring Systems Compared to Venous and Capillary Glucose

2013 –PI – Leslie Klaff, MD, Ph.D

A Clinical Trial to Evaluate the Performance and Safety of Two Intradermal Delivery Devices

2013 –PI –Leslie Klaff, MD,Ph.D

Performance of An Investigational Blood Glucose Monitoring System

2013 – PI – Leslie Klaff, MD, Ph.D (Phase 3b)

A Study of the Safety and Effective Use of An Investigational Single Use Injection Device in Patients with Type 2 Diabetes Who are Injection Naïve

2013 –PI – Allen Sussman, MD

A Study of An Investigational Glucose Monitoring System with An Investigational Test Strip ISO 15197 Section 8 User Performance Evaluation.

2012 –PI – Ronald Brazg, MD

Accuracy and User Performance Evaluation of A Marketed Blood Glucose Meter and β-ketone Monitoring System

2012 –PI – Ronald Brazg, MD

Accuracy Evaluation of A Marketed Blood Glucose Monitoring System with Venous Blood

2012 –PI – Ronald Brazg, MD

Accuracy and User Performance Evaluation of the A Modified Marketed Blood Glucose Test Strip with An Insulin Pump System for Finger and Alternative Site Capillary Blood Testing

2012 – PI – Ronald Brazg, MD

User Evaluation of Several Features of An Investigational Blood Glucose Monitoring System

2012 –PI – Ronald Brazg, MD

Pivotal In-Home Study to Determine Safety and Efficacy of the LGS Feature in Sensor-Augmented Pumps

2012 –PI –Leslie Klaff, MD, Ph.D

Modified Labeling Validation Study Protocol of a Blood Glucose Meter

2012 –PI –Leslie Klaff, MD, Ph.D

Clinical Evaluation of Blood Glucose Meters Compatible with An Investigational Test Strip and BGMs from other Companies

2012 –PI –Leslie Klaff, MD, Ph.D

Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade in Normal Subjects

2012 – PI –Leslie Klaff, MD, Ph.D

Clinical Evaluation of the Whole Blood and Serum Precision on an Investigational POC Lipid Panel Analyzer

2012 – PI –Leslie Klaff, MD, Ph.D

Clinical Evaluation of the Accuracy of An Investigational POC Lipid Panel Analyzer in a Point-of-Care Setting

2011 –PI – Ronald Brazg, MD

Blood Glucose Competitive System Capillary Accuracy Testing

2011 –PI – Ronald Brazg, MD

A Performance Evaluation of An Investigational Glucose Sensor to Support A Full 144 Hours (6 Days) of Use

2011 – PI – Ronald Brazg, MD

Accuracy Evaluation of the An Investigational Blood Glucose Monitoring System for Venous Blood

2011 – PI – Ronald Brazg, MD

Phase I Performance and Safety Evaluation of An Investigational Intradermal Delivery Device

2011 – PI – Ronald Brazg, MD

Accuracy and User Performance Evaluation of the An Investigational Blood Glucose Test Strip for Finger Capillary Blood Testing

2011 – PI – Leslie Klaff, MD, Ph.D

A Regulatory Clinical Evaluation – Lay User and Professional Comparison to a Validated Method.

2011 – PI – Leslie Klaff, MD, Ph.D

A Regulatory Clinical Evaluation – Human Factors, Instructions for Use, and Marketing Claims Study

2011 – PI – Allen Sussman, MD

Comparison of Insulin Dose Derived From An Investigational Glucose Meter Software and Conventional Manual Calculation

2010 – PI – Ronald Brazg, MD

A Study of An Investigational Glucose Test Strip Patient Vs. Technician Capillary Evaluation

2010 –PI – Ronald Brazg, MD

An Investigatonal Test Strip with A Blood Glucose Monitoring System Alternative Site Capillary Evaluation

2010 –PI – Ronald Brazg, MD

An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor

2010 – PI – Leslie Klaff, MD, Ph.D

A Regulatory Clinical Evaluation of An Investigational Blood Glucose Meter – Lay User and Professional Comparison to a Validated Method, Instructions for Use, Human Factors, and Marketing Claims Study

2010 –PI – Leslie Klaff, MD, Ph.D

A Regulatory Clinical Evaluation of An Investigational Blood Glucose Meter – Lay User and Professional Comparison to a Validated Method and Instructions for Use Evaluation

2010 –PI – Allen Sussman, MD

A Study of A Blood Glucose Monitoring System with the An Investigational Test Strip Alternative Site Capillary Evaluation Patient vs. Technician

2010 – PI Ronald Brazg, MD

Accuracy and User Performance Evaluation of An Investigational Modified Blood Glucose Test Strip for Alternative Site Capillary Blood Testing (included 9 subjects with blood glucose under 75 mg/dL)

2010 –  PI –  Ronald Brazg, MD

An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor

2010 –PI –  Ronald Brazg, MD

Project Gemini (Gen 1 meter)- GDHFAD System) Blood Glucose Monitoring System: Comparison of Lay User and Professional Glucose Results to a Validated Method

2010 –PI –  Ronald Brazg, MD

Accuracy and User Performance Evaluation of the Modified FreeStyle Blood Glucose Test Strip for Finger and Alternative Site Capillary Blood Testing

2010 –PI-Ronald Brazg, MD

A Study of An Investigational Glucose Test Strip with An Approved Glucose Meter Alternative Site Capillary Evaluation Patient vs. Technician.

2010 – PI –  Leslie Klaff, MD, Ph.D

Labeling Comprehension and Human Factors Clinical Regulatory Study

2010 –PI –  Allen Sussman, MD

Protocol for User Evaluation of the Performance of An Investigational Blood Glucose Monitoring System

2010 PI – Ronald Brazg, MD

Design Validation Study of the An Investigational Continuous Glucose Monitoring System

2010 PI – Ronald Brazg, MD

An In-Clinic, Randomized, Cross-Over Study to Assess the Efficacy of the Low Glucose Suspend (LGS) Feature of An Investigational Insulin Pump System with Hypoglycemic Induction from Exercise.

2009 – PI – Ronald Brazg, MD

Accuracy and User Performance Evaluation of An Investigational Blood Glucose Test Strip for Finger and Alternative Site Capillary Blood Testing

2009 – PI – Ronald Brazg, MD

Accuracy and User Performance Evaluation of An Investigational Blood Glucose Test Strip for Finger and Alternative Site Capillary Blood Testing

2009 – PI – Leslie Klaff, MD, Ph.D

Ultrasound Evaluation of the Skin and Subcutaneous Layer Thickness of Anatomical Sites Commonly Used for Subcutaneous Insulin Injections.

2009 –PI – Leslie Klaff, MD, Ph.D

Comparison of Glycemic Control Among Diabetics Using An Investigational Pen Needle Versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle

2009 –PI – Leslie Klaff, MD, Ph.D

Accuracy Evaluation of the Modified Investigational Blood Glucose Test Strip for Venous Blood Testing

2009 –PI – Leslie Klaff, MD, Ph.D

An Investigational Blood Glucose Monitoring System Professional and Lay User Performance, Labeling Comprehension, AST, and Marketing Claims Regulatory Study

2009 – PI – Ronald Brazg, MD

An Inpatient Evaluation of a Six-Day Subcutaneous Glucose Sensor Performance

2009 – PI – Leslie Klaff, MD, Ph.D

A Study to Determine the Comprehensibility of the User Instructions for the A Marketed Home Collection Kit

2009 – PI – Ronald Brazg, MD

A Study of An Investigational Glucose Test Strip Patient Vs. Technician Capillary Evaluation

2008 –PI – Ronald Brazg, MD

Patient Reporting of Type 2 Diabetes Symptoms

2008 – PI – Ronald Brazg, MD

In Clinic Evaluation of An Investigational Continuous Glucose Monitoring System

2008 – PI – Leslie Klaff, MD, Ph D

A Study of an Investigational Blood Glucose Monitoring System Lay User and Professional Clinical Accuracy, Labeling Comprehension, Human Factors, and AST Regulatory Study

2007 – PI – Ronald Brazg, MD

An Evaluation of An Investigational Six-Day Subcutaneous Glucose Sensor Performance in Subjects with Type 1 Diabetes Mellitus.

2007 – PI – Ronald Brazg, MD

A Randomized, Parallel Study to Compare Performance An Investigational Continuous Glucose Sensor to An Approved Continuous Glucose Sensor

2007 – PI – Leslie Klaff, MD, Ph D

Blood Glucose Monitoring System Clinical Accuracy, Labeling Comprehension, and Human Factors Study

2006- PI – Ronald Brazg, MD

Clinical Study of Perceived Pain with An Investigational Continuous Glucose Monitoring System Compared to Lifescan and Roche Blood Glucose Monitoring Systems.

2005– PI – Leslie Klaff, MD, Ph.D

Multi-Center, Randomized, Home-Use Study of the Investigational 31 Gauge Thin, Wall x3mm Pen Needle and Currently Marketed 31 Gauge, Thin Wall x 5mm Pen Needle To Compare Glycemic Control in Subjects with Diabetes Mellitus

2005 –PI – Ronald Brazg, MD

Clinical Evaluation of the Accuracy of An Investigational Continuous Glucose Monitoring System

2004 – PI – Ronald Brazg, MD

Clinical Evaluation of an investigational Glucose Meter

2004 – PI – Leslie Klaff, MD, Ph.D

Clinical Evaluation of an Investigational Glucose Monitor.

2002 –PI – Ronald Brazg, MD (Phase 1)

Clinical Evaluation of an Investigational Glucose Monitoring System

Epilepsy

2017 –PI – David Vossler, MD (Phase 3)

A Multicenter, Double-Blind, Randomized, Placebo Controlled Trial With An Open-Label Extension Phase of An Investigational Medication as Adjunctive Treatment in Subjects at Least 2 Years of Age With Inadequately Controlled Seizures Associated with Lennox-Gastaut Syndrome.

2016 –PI – David Vossler, MD (Phase 3)

An Open Label, Multicenter, Safety and Pharmacokinetic Study of An Investigational Medication as Adjunctive Therapy in Subjects with Partial Onset Seizures.

2015 –PI – David Vossler, MD (Phase 2b)

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of An Approved Medication as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects with Idiopathic Generalized Epilepsy.

2015 –PI – David Vossler, MD (Phase 2b)

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of An Approved Medication as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects with Idiopathic Generalized Epilepsy.

2015 –PI – David Vossler, MD (Phase 2)

An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of An Investigational Nasal Spray in Adolescents and Adults with Cluster Seizures.

2013 – PI – David Vossler, MD (Phase 2b)

A Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Determine the Efficacy and Safety of An Investigational Medication as Adjunctive Therapy for Adults with Drug-Resistant Partial-Onset Seizures Followed by Long-term Open-Label Treatment.

2013 – David Vossler, MD (Phase 3)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Trial of An Approved Medication as Adjunctive Therapy in Pediatric and Adult Subjects with Primary Generalized Tonic-Clonic Seizures

2012 –PI – David Vossler, MD (Phase 3)

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of An Investigational Medication in Subjects With Treatment-Resistant Partial Epilepsy

2012 –PI – David Vossler, MD (Phase 3)

A Historical-Controlled, Multicenter, Double-Blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to An Investigational Medication Monotherapy in Subjects with Partial-onset Seizures

2012 –PI – David Vossler, MD (Phase 3)

Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of An Investigational Medication Monotherapy in Subjects with Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

2011 –PI – David Vossler, MD (Phase 3)

Efficacy and Safety of An Investigational Medication As Adjunctive Therapy for Refractory Partial Seizures in a Double Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre Clinical Trial

2010 –PI – David Vossler, MD (Phase 2)

An Open Label Pilot Study To Assess the Safety of An Oral Investigational Medication as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects with Idiopathic Generalized Epilepsy

2010 –  PI – David Vossler, MD (Phase 2)

A Historical-Controlled, Multicenter, Double-Blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to An Investigational Medication 400mg/day Monotherapy in Subjects with Partial-Onset Seizures

Gastroenterology

2000 PI – William Pearce, MD

A Comparative Efficacy Study of An Investigational Medication and Lansoprazole (30 mg qd) in Patients with Erosive Esophagitis

1999 PI – William Pearce, MD

A Comparative Efficacy and Safety Study of H199/18 (40 mg) and Omeprazole (20 mg) in Study Subjects with Erosive Esophagitis

1997 PI – William Pearce, MD

A Multicenter, Randomized, Double-Blind, Eight Week Comparative Efficacy and Safety Study of an Investigational Medication 20 mg, an Investigational Medication 40 mg and Omeprazole 20 mg in Study Subjects with Erosive Esophagitis

1993 PI – Duane Carlson, MD

A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of an Investigational Medication Compared with Ranitidine and GR88502X for the Prophylaxis of Nonsteroidal Anti-Inflammatory Drug-Associated Gastric or Duodenal Ulcers in Patients with Osteo- or Rheumatoid Arthritis and Without a History of Gastric or Duodenal Ulcers

Herpes Zoster

2016 –PI – Leslie Klaff, MD, Ph.D (Phase 3b)

A Phase IIIB, Non-Randomized, Open-Label, Multi-Country, Multi-Centric Cross-Vaccination Study to Evaluate the Safety of An Investigational Vaccine for Herpes Zoster When Administered Intramuscularly on a Two-Dose Schedule to Subjects Who Previously Received Placebo in the Base Study.

1994 PI’s – Peter Jones, MD & Ronald Brazg, MD

A Double-Masked, Double-Dummy, Randomized, Acyclovir Controlled, Parallel Group Study to Compare the Efficacy and Safety of an Investigational Medication with Acyclovir in the Treatment of Patients with Ophthalmic Zoster.

Hypercholesterolemia

2015– PI – Leslie Klaff, MD, Ph D (Phase 2)

A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding An Investigational Medication to 180 MG to Atorvastatin 80 MG Background Therapy in Statin-Treated Patients.

2015– PI – Allen Sussman, MD  (Phase 2a)

Randomized Evaluation of An Investigational Medication to Suppress LDL Cholesterol in Patients with Dyslipidemia.

2015 –PI – Ronald Brazg, MD (Phase 2)

A 12-Week, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability and Actual Use of An Investigational Medication and An Autoinjector (Pre-Filled Pen) in Subjects with Primary Hyperlipidemia or Mixed Dyslipidemia

2013 – PI – Ronald Brazg, MD (Phase 3)

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Long-Term Safety and Tolerability of An Investigational Medication in Subjects with Primary Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events.

2013 –PI – Ronald Brazg, MD (Phase 2)

A Double-Blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety and Efficacy of An Investigational Medication in Subjects With a 10 Year Framingham Risk Score of 10% or Less and Currently Not Receiving Prescription Lipid-lowering Therapy

2013 –PI – Allen Sussman, MD (Phase 3)

A Randomized, Double-Blind Study of the Efficacy and Safety of An Investigational Medication Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin

2013 – PI – Allen Sussman, MD (Phase 2)

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of An Investigational Medication, Ezetimibe and the Combination in Hypercholesterolemia Patients With or Without Statin Intolerance.

2012 –PI – Ronald Brazg, MD (Phase 2)

A Double-Blind, Randomized, Placebo -Controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of An Investigational Subcutaneously Injected Medication on LDL-C in Hypercholesterolemic Subjects

2011 – PI – Ronald Brazg, MD (Phase II)

A Randomized, Placebo and Ezetimibe Controlled, Dose-Ranging Study to Evaluate Tolerability and Efficacy of An Investigational Subcutaneously Injected Medication on LDL-C in Hypercholesterolemic Subjects with a 10 year Framingham Risk Score of 10% or Less

2011 – PI – Leslie Klaff, MD, Ph.D (Phase III)

A Randomized, Double-Blind, Active-Controlled, Multicenter, Crossover Study to Evaluate the Efficacy and Safety of A Fixed-Dose Combination Tablet Compared to Co-administration of Marketed Ezetimibe 10 mg and Atorvastatin 20 mg in Patients with Primary Hypercholesterolemia

2009   PI – Allen Sussman, MD

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of an Investigational Extended-Release oral medication in Patients with Dyslipidemia

2008   PI – Ronald Brazg, MD (Phase III)

A Multicenter, Randomized, Placebo-Controlled, “factorial”design, 12-Month Study to Evaluate the Efficacy and Safety of an investigational medication 25mg/Day and 50mg/Day co-administered with all registered Atorvatatin Stengths Ranging from 10mg to 80mg in Patients with Primary Hypercholesterolemia

2008   PI – Leslie Klaff, MD, Ph D (Phase III)

A Multicenter, Double-Blind, Randomized, 12-Month, Placebo-Controlled Study to Evaluate the Lipid-Lowering Effect, Safety, and Tolerability of an investigational medication 25mg/Day and 50mg/Day When Added to Ongoing Stable Statin Therapy (HMG-CoA reductase inhibitors) in Patients With Primary Hypercholesterolemia

2008   PI – Allen Sussman, MD (Phase III)

A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added on to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients with Hypercholesterolemia at Risk for Coronary Heart Disease

2008   PI – Allen Sussman, MD (Phase IIa)

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Tolerability of an investigational medication Co-Administered with Atorvastatin in Patients with Primary Hypercholesterolemia

2007 PI – Ronald Brazg, MD (Phase III)

A Multicenter, Prospective, Longitudinal, Randomized, Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of Pravastatin 40mg or Fenofibrate 160 mg or An Investigational Combination Medication for 12 Weeks Followed by a 52-Week Open Label Safety Phase of the Investigational Combination Medication Alone in the Treatment of Combined Hyperlipidemia.

2007 PI – Ronald Brazg, MD (Phase II)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of the Combination of an Investigational Medication and Atorvastatin 20mg vs. Monotherapy in Subjects With Moderate Hypercholesterolemia.

2007 PI – Allen Sussman, MD (Phase III)

A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10mg When Added to Atorvastatin 10mg Versus Titration to Atorvastatin 20mg and to 40mg in Elderly Patients with Hypercholesterolemia at High Risk for CHD.

2006- PI – Allen Sussman, MD (Phase IIb)

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Does-Ranging Study to Assess the Efficacy, Safety, and Tolerability of An Investigational Medication in Patients with Primary Hypercholesterolemia or Mixed Hyperlipidemia

2006 – PI – Leslie Klaff, MD, PhD (Phase III)

A Phase 3, Open-Label, Multi-Center, Randomized, Parallel Group Study of The Efficacy and Safety of Fixed Combination Investigational Medication/Atorvastatin Administered Once Daily (QD) Compated to Fixed Combination Ezetimibe/Simvastatin for 6 Week In Subjects with Dyslipidemia

2006 –PI – Allen Sussman (Phase III)

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of An Investigational Medication in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

2006 PI – Leslie Klaff, MD, PhD (Phase III)

A Multicenter, Randomized, Double-Blinded, Prospective Study Comparing the Safety and Efficacy of An Investigational Combination Therapy to Fenofibric Acid and Simvastatin Monotherapy in subjects with Mixed Dyslipidemia

2006 – PI – Leslie Klaff, MD, PhD (Phase III)

A Multicenter, Randomized, Double-Blinded, Prospective Study Comparing the Safety and Efficacy of An Investigational Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in subjects with Mixed Dyslipidemia

2005 – PI – Ronald Brazg, MD (Phase III)

A Multicenter, Randomized, Double-Blind, Parallel-Group, 6-Week Study to Evaluate the Efficacy and Safety an Investigational Medication Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia

2005 – PI – Ronald Brazg, MD (Phase III)

Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of An Investigational Medication, for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Intima-Media Thickness (CIMT), in Overweight Patients With Additional Risk Factors

2005 – PI – Leslie Klaff, MD, Ph.D (Phase III)

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of An Investigational Medication When Co-Administered With Atorvastatin (10mg to 40mg) In Subjects With Primary Hypercholesterolemia

2005 – PI – Allen Sussman, MD (Phase IIa)

A Multicenter, Randomized, Double-Blind, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of an investigational medication Compared to NIASPAN

2004 – PI – Ronald Brazg, MD (Phase 3)

A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of an investigational medication Versus Rosuvastatin in Patients With Primary Hypercholesterolemia.

2004 – PI – Leslie Klaff, MD, Ph.D (Phase III)

A Phase 3, double-blind, placebo-controlled, randomized, parallel group, multicenter study of the efficacy, safety and tolerability of an investigational medication administered orally, once daily for 24 weeks, compared to atorvastatin alone or placebo, in subjects with Frederickson Type IIa dyslipidemia.

2004 –PI – Allen Sussman, MD (Phase III)

A Study to Evaluate the Efficacy and Safety of an investigational medication Coadministration in Patients With Mixed Hyperlipidemia

2004 – PI – Allen Sussman, MD (Phase IIb)

Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of an investigational medication Compared to Placebo. Part B: A Dose-Ranging Study to Evaluate the Tolerability of an investigational medication and its Effects on Niacin-Induced Flushing in Lipid Clinic Patients.

2003 – PI – Leslie Klaff, MD, Ph.D.. (Phase 4)

A Multicenter, Double-Blind, Randomized, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of An Investigational Medication Tablet Versus Atorvastatin in Patients With Hypercholesterolemia.

2003 – Leslie Klaff, MD, Ph.D. (Phase 3)

Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-Mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination Investigational medication, Administered Orally, Once Daily (QD) for 24 Months, Compared with Atorvastatin Alone, in Subjects with Mixed Hyperlipidemia

2002 –PI – Ronald Brazg, MD (Phase II)

Phase 2 multi-center, double-blind investigational medication, placebo-controlled, randomized, parallel group, dose ranging study of the efficacy, safety, tolerability, and pharmacokinetics of an investigational medication and open-label atorvastatin when concurrently administered orally once daily (QD) for 12 weeks to subjects with elevated low-density lipoprotein cholesterol and without overt cardiovascular disease

2002 – PI – Allen Sussman, MD (Phase 2)

An 8-Week, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of an investigational medication Administered in Combination With Atorvastatin or Alone to Hypercholesterolemic Patients

2002 – (PI – Ronald Brazg, MD (Phase II)

Phase 2 multi-center, double-blind investigational medication, placebo-controlled, randomized, parallel group, dose ranging study of the efficacy, safety, tolerability, and pharmacokinetics of the investigational medication and open-label atorvastatin when concurrently administered orally twice daily (BID) for 12 weeks to subjects with elevated low-density lipoprotein cholesterol and without overt cardiovascular disease

2002 PI – Ronald Brazg, MD

Phase 2 multi-center, double-blind, placebo-controlled, randomized, parallel group, dose ranging study of the safety, efficacy and tolerability of an oral formulation of an investigational medication administered once a day for 8 weeks to subjects with moderate elevations in low-density lipoprotein cholesterol levels and without overt cardiovascular disease.

2002 PI – Ronald Brazg, MD

A multicenter, double-blind, randomized, placebo- and active-controlled, parallel study to evaluate the lipid altering efficacy and safety of an investigational medication in patients with metabolic syndrome and dyslipidemia.

2002 PI – Ronald Brazg, MD

A Randomized, double – blind, parallel, multicenter study to evaluate the efficacy and safety of Simvastatin monotherapy compared with simvastatin plus an investigational medication in Type 2 Diabetic patients treated with Thiazolidinediones.

2002 PI – Leslie Klaff MD, PhD.

A multicenter, randomized, double-blind, placebo-and-active-controlled parallel group dose-ranging study of an investigational medication in the treatment of hyperlipidemia.

2002 PI – Allen Sussman, MD

A comparison of treatment with an investigational medication and Simvastatin coadministration versus Simvastatin in attaining the National Cholesterol Educational Program (NCEP) Adult Treatment Panel (ATP) III coronary heart disease (CHD) or CHD risk equivalent strata low-density lipoprotein cholesterol (LDL-C) Target Level.

2001 PI – Ronald Brazg, MD

A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group, Study of the Safety and Efficacy of Cerivastatin in Combination with Fenofibrate Alone and Placebo in a Population of Type 2 Diabetic Men and Women

2001 PI – Leslie Klaff, MD, Ph.D.

A 6-week, Open-Label, Dose-Comparison Study to Evaluate Statins in Subjects With Hypercholesterolemia

2000 PI – Ronald Brazg, MD

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced-Titration Study of the Safety and Effectiveness of An Investigational Medication vs. Placebo in Japanese-American and Caucasian-American Patients With Hypercholesterolemia

2000 PI – Ronald Brazg, MD

An Open-Label Randomized Study of the Relative Efficacy of An Investigational Medication compared to Simvastatin and Atorvastatin

2000 PI – Leslie Klaff, MD, Ph.D.

A Double-Blind Comparison of An Investigational Medication with Placebo in Hypercholesterolemic Subjects

2000 – PI Allen Sussman, MD

A Randomized, Double-Blind, Placebo-Controlled, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Treatment With A Lipid-Lowering Medication In Thiazolidinedione-Treated (Pioglitazone or Rosiglitazone) Type 2 Diabetic Patients

1999 PI – Ronald L. Brazg, MD

Evaluation of the Safety and Efficacy of Nicostatin (a combination tablet of niacin extended-release/lovastatin immediate release): A Dose Ranging Study

1999 PI – Leslie J. Klaff, MD, Ph.D.

A 12-week Randomized Double-blind Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of ZD4522 (5 and 10mg) and Atorvastatin (10mg) in the treatment of Subjects with Hypercholesterolemia.

1998 PI – Leslie J. Klaff, MD, Ph.D.

An Open-Label, Community-Based Clinical Practice Study of Niaspan in Patients with Hyperlipidemia

1997 PI – Ronald L. Brazg, MD

A Randomized, Double-Blind, Parallel Group Evaluation of an Investigational Medication 0.8 mg Compared to an Investigational Medication 0.4 mg and Placebo/Pravastatin 20 mg Once Daily in Patients with Hypercholesterolemia

1996 PI – Leslie Klaff, MD, Ph.D.

A Randomized, Double-blind, Parallel Group Evaluation of an Investigational Medication compared to Fluvastatin 40 mg and Placebo Daily in Patients with Hypercholesterolemia

1995-1996 PI – Allen Sussman, MD

Third Long-Term Extension to: A Double-blind Dose-Ranging Study of an Investigational Medication Compared to Placebo and to Lovastatin taken once daily in Patients with Hypercholesterolemia.

1995 PI – Allen Sussman, MD

A Double-blind Dose-Ranging Study of an Investigational Medication Compared to Placebo and to Lovastatin taken Once Daily in Patients with Hypercholesterolemia.

1993-94 PI – Nancy L. Purcell, MD

A Double Blind Dose-Ranging Study of an Investigational Medication taken Once Daily Compared to Placebo and to Lovastatin taken Once Daily in Patients with Hypercholesterolemia

1991-1992 PI – Leslie J. Klaff, MD, Ph.D.

A Double-blind Pilot Dose Ranging Study of an investigational medication taken Once Daily Compared to Placebo and to Lovastatin taken Once Daily in Patients With Hypercholesterolemia

Hypertension

2012 –PI – Ronald Brazg, MD (Phase I)

Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety,Tolerability, Pharmacokinetics and Pharmacodynamic Response of An Investigational Injection Following a Single Subcutaneous Doses in Adult Subjects with Stage 1 or Stage 2 Essential Hypertension

2009 –PI – Leslie Klaff, MD, Ph.D (Phase IV)

An 8-Week Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients with Stage 2 Hypertension

2009 – PI – Ronald Brazg, MD (Phase IV)

A Prospective, Open-Label Titration Study to Evaluate the Efficacy and Safety of An Investigational Medication in Multiple Subgroups of Hypertensive Subjects who are Non-Responders to Anti-Hypertensive Monotherapy.

2008 –PI – Ronald Brazg, MD (Phase IIb)

A Worldwide, Multicenter, Double Blind, Randomized, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of An Investigational Medication When Added to Ongoing Therapy With Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) in Patients With Diabetes and Hypertension

2007 PI – Allen Sussman, MD (Phase III)

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of An Investigational Medication When Co-Administered with Amlodipine 5 mg in Subjects with Essential Hypertension.

2007 PI – Allen Sussman, MD (Phase III)

An 8-Month Phase 3, Open-Label Study With a Blinded Reversal Phase to Evaluate the Safety and Tolerability of An Investigational Medication in Subjects with Essential Hypertension

2006- PI – Leslie Klaff, MD, Ph. D (Phase II)

A Phase II, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-491 in Subjects with Mild to Moderate Uncomplicated Essential Hypertension

2006- PI – Allen Sussman, MD (Phase III)

An 8-week, multicenter, randomized, double-blinded, parallel-group study to evaluate the efficacy and safety of the combination of Valsartan/HCTZ/Amlodipine compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in patients with moderate to severe hypertension

2005 –PI – Leslie Klaff, MD, Ph. D. (Phase IV)

A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of an investigational medication Combination as Compared to an investigational medication in Patients with Essential Hypertension.

2005 – PI – Allen Sussman, MD (Phase IV)

A 26 week, double-blind, randomized, multicenter, parallel group, active-controlled study comparing an investigational medication to ramipril with optional addition of hydrochlorothiazide, followed by a 4 week double-blind, randomized, placebo-controlled withdrawal in patients with essential hypertension.

2002 –PI – Ronald Brazg, MD (Phase IV)

A Multicenter, Randomized, Double-Blind, Parallel Group Study Comparing the Safety and Efficacy of Lotrel versus Amlodipine in the treatment of Moderate to Severe Hypertension.

2001 PI – Leslie Klaff, MD

A Randomized, Double-Blind Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients with Type II Diabetes Mellitis

2000 PI – Ronald Brazg, MD

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel 9-Week, Dose Ranging Study of An Investigational Medication in the Treatment of Mild to Moderate Hypertension

2000 PI – Ronald Brazg, MD

A Randomized, Double-Blind Safety and Efficacy Study of Two Approved Antihypertensive Medications as First-Line Therapy After 6 Weeks in Patients With Severe Hypertension

1998 PI – Ronald Brazg, MD

A Multicenter, Randomized, Double-blind, Amlodipine and Placebo-Controlled, 10 Week Study of an Investigational Medication in the Treatment of Mild to Moderate Hypertension.

1997 PI – Allen Sussman, MD

A Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Parallel Dose-Ranging Study of an Investigational Medication in the Treatment of Mild to Moderate Hypertension.

1997 PI – Allen Sussman, MD

A 12 week, Multicenter, Double-blind, Parallel, Positive-Controlled, Dose-Titration Study of an Investigational Medication compared to Enalapril in Patients with Severe Systolic Hypertension.

1997 PI – Allen Sussman, MD

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Nine Week Study of an Investigational Medication in the Treatment of Mild to Moderate Hypertension

1996 PI – Ronald Brazg, MD

A Fifty-Two Week, Multicenter, Double-blind, Placebo-Controlled, Parallel-Group Study to Compare the Effects of an Investigational Medication With Those of Placebo in Mild to Moderate Obese Patients Whose Hypertension is Controlled by an Angiotensin-Converting Enzyme Inhibitor, With or Without Concomitant Thiazide Diuretic Therapy.

1995-1996 PI – Allen Sussman, MD

A Randomized, Double-blind, Outpatient, Dose-Titration Trial of an Investigational Medication Versus Placebo in Patients with Essential Hypertension.

1992-1993 PI – Nancy L. Purcell, MD

Accupril Decision on Pharmacotherapy for Hypertension

Hypogonadism

2017 – PI – Ronald Brazg, MD (Phase 3)

A 12-Month, Randomized, Active Controlled, Open Label Study of the Efficacy and Safety of An Investigational Oral Testosterone Undecanoate in Hypogonadal Men.

2017 – PI – Ronald Brazg, MD (Phase 1)

Dosing Flexibility Study of An Investigational Oral Testosterone in Hypogonadal Men.

2016 – PI – Ronald Brazg, MD (Phase 1)

Validation of Dosing Regimen of An Investigational Oral Testosterone in Hypogonadal Men.

2015 – PI – Allen Sussman, MD (Phase 3)

A 6-Month Safety Study of An Investigational Medication Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism.

2014 –PI – Allen Sussman, MD (Phase 3)

A Double-Blind, Multiple-Dose, 52-Week Study to Evaluate the Efficacy and Safety of An Investigational Testosterone Medication Administered Subcutaneously Once Each Week to Adult Males with Hypogonadism.

2013 –PI – Allen Sussman , MD (Phase 3)

Phase III, Open-Label Study of the Safety and Efficacy of An Oral Investigational Medication in Hypogonadal Men

2011 –PI – Allen Sussman, MD (Phase 3)

A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of An Intranasal Investigational Medication in the Treatment of Male Hypogonadism with Sequential Safety Extension Periods of 90 and 180 Days

Insomnia

2007 – PI – Leslie Klaff, MD, Ph.D (Phase III)

Efficacy and Safety of 2 mg/day of An Investigational Medication on Sleep Maintenance Insomnia with a Sub-Study of the Effect of An Investigational Medication on Stable Type II Diabetes Mellitus: A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.

Metabolic Syndrome

2006 PI – Ronald Brazg, MD (Phase 3)

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter study Evaluating the Efficacy and Safety of Three Doses of an Investigational Medication in Abdominally Obese Patients with Atherogenic Dyslipidemia.

2006 PI – Ronald Brazg, MD (Phase 3)

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter study Evaluating the Efficacy and Safety of Three Doses of an Investigational Medication in Abdominally Obese Patients with Atherogenic Dyslipidemia.

2005 PI – Ronald Brazg, MD (Phase 3)

Randomized, multicenter, double-blind, placebo-controlled, two-arm parallel group trail of rimonabant 20-mg od, for inhibitor of atherosclerosis progression assessed by carotid artery intima-media thickness (CIMT), in overweight patients with additional risk factors.

Osteoporosis

2011 –PI – Leslie Klaff, MD, Ph.D (Phase I)

A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalating Study Of An Investigational Medication in Postmenopausal Women with Osteoporosis

Other Indications

2012 – Leslie Klaff, MD, Ph.D.

A Randomized, Double Blinded, Negative and Positive Controlled Study for Evaluation of the Allergenicity of A Marketed Medication in Healthy Volunteers Using Intradermal Skin Test

2010 – PI – Leslie Klaff, MD, Ph D (Phase 3)

A Phase III, Randomized, Observer-Blind, Placebo-Controlled, Multicenter, Clinical Vaccination Trial to Assess the Prophylactic Efficacy, Safety, and Immunogenicity of An Investigational Vaccine When Administered Intramuscularly on a 0, 2-Month Schedule in Adults aged 50 Years and Older.

2010 –PI – Leslie Klaff, MD, Ph D (Phase 3)

A Phase III, Randomized, Observer-Blind, Placebo-Controlled, Multicenter, Clinical Vaccination Trial to Assess the Prophylactic Efficacy, Safety, and Immunogenicity of An Investigational Vaccine When Administered Intramuscularly on a 0, 2-Month Schedule in Adults aged ≥ 70 Years.

Panic Disorder

1997 PI – Barnett Kaplan, MD

A Double-blind, Placebo Controlled, Flexible Dosing Trial to Evaluate the Efficacy of an Investigational Medication in the Treatment of Panic Disorder.

Phase 1

2017 –PI – Leslie Klaff, MD, Ph D (Phase I)

A Randomized, Placebo-Controlled, Double-Blind, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of a single and Repeated Subcutaneous Doses of An Investigational Medication in Subjects with Type 2 Diabetes Mellitus.

2014 –PI – Ronald Brazg, MD (Phase I)

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of An Investigational Medication in Subjects with Type 2 Diabetes.

2013 –PI – Leslie Klaff, MD, Ph D (Phase I)

A Phase 1, Randomized, Double-blind, Placebo Controlled Parallel-Group Study to Evaluate thePharmacodynamic and Pharmacokinetic Effects of An Investigational Medication in Subjects with Type 2 Diabetes Mellitus and Moderate to Severe Renal Impairment

2012 –PI – Ronald Brazg, MD (Phase I)

Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Response of An Investigational Injection Following a Single Subcutaneous Doses in Adult Subjects with Stage 1 or Stage 2 Essential Hypertension

2011 – PI – Ronald Brazg, MD (Phase 1/2A)

Phase 1/2A, Randomized, Double-Bind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Response of An Investigational Injection Following Single and Multiple Ascending Subcutaneous Doses in Adult Subjects with Type 2 Diabetes Mellitus

2011 – PI – Leslie Klaff, MD, Ph.D (Phase I)

A Phase 1 Study in Patients with Type 1 Diabetes Mellitus to Evaluate the Single and Multiple Dose Pharmacokinetics and Safety of An Investigational Medication After Subcutaneous Administration

2011 –PI – Leslie Klaff, MD, Ph.D (Phase I)

A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalating Study Of An Investigational Medication in Postmenopausal Women with Osteoporosis

2011 – PI – Allen Sussman, MD (Phase I)

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of An Investigational Medication Alone and With Atorvastatin

Thyroid

1999 PI – Allen M. Sussman, MD

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study of the Safety and Efficacy of Synthroid in Patients with Mild Thyroid Failure

Weight Loss / Obesity

2017 – PI – Ronald Brazg, MD (Phase 2b)

A Randomized, Double Blind, Dose Finding Study to Evaluate the Change in Weight After 24 Weeks Treatment With 8 Doses of An Investigational Medication Compared to Placebo in Obese or Overweight Adults Followed by 24 Weeks Treatment With 2 Doses of An Investigational Medication and Placebo.

2017 – PI – Ronald Brazg, MD

A Randomized, Double Blind, Placebo Controlled, Parallel Group Study Assessing the Effect of An Investigational Device on Body Weight in Overweight and Obese Subjects with Prediabetes and Metformin-Treated Type 2 Diabetes.

2014 – PI – Leslie Klaff, MD, Ph D (Phase 2)

A 20-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial to Assess the Safety and Efficacy of An Investigational Medication on Body Weight in Obese Subjects Without Diabetes.

2013 –PI – Leslie Klaff, MD, Ph D (Phase 2)

A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of A Novel Investigational Medication in Obese Patients

2011 –PI – Allen Sussman, MD (Phase 3a)

Effect of An Investigational Medication on Body Weight in Non-Diabetic Obese Subjects or Overweight Subjects With Comorbidities: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre, Multinational Trial with Stratification of Subject to Either One or Three Years of Treatment Based on Pre-Diabetes Status at Randomization.

2010 –PI – Ronald Brazg, MD (Phase 2b)

A Double Blind, Multi-Center, Randomized, Parallel-Group, Study to Assess the Efficacy and Safety 400 mg of An Investigational Medication and 120 mg of Orlistat Administered Individually or Combined Orally Three Times Per Day with a Reduced Calorie Diet (RCD) in Obese Subjects.

2010 –PI – Ronald Brazg, MD (Phase 2b)

A Double Blind, Multi-Center, Randomized, Parallel-Group, Study to Assess the Efficacy and Safety 400 mg of An Investigational Medication and 120 mg of Orlistat Administered Individually or Combined Orally Three Times Per Day with a Reduced Calorie Diet (RCD) in Obese Subjects.

2009 –PI – Allen Sussman, MD (Phase 3a) – Study Awarded

Effect of An Investigational Medication on Body Weight in Non-Diabetic Obese Subjects or Overweight Subjects With Comorbidities: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre, Multinational Trial with Stratification of Subject to Either One or Three Years of Treatment Based on Pre-Diabetes Status at Randomization.

2008 PI – Leslie Klaff, MD, Ph D (Phase 2)

The Effect of Dose Titration of an Investigational Medication in Overweight and Obese Patients with Type 2 Diabetes Mellitus

2008 PI – Ronald Brazg, MD (Phase 2)

A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Efficacy and Safety Trial to Evaluate the Effect of an investigational medication on Weight in Obese and Overweight Subjects

2007 PI – Ronald Brazg, MD (Phase 3)

A Double-Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Asssess the Efficacy and Safety of An Investigational Medication Administered Orally Once Daily with A Reduced Calorie Diet in Obese Males and Females.

2007 PI – Allen Sussman, MD (Phase 3)

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Safety and Efficacy of An Investigational Medication in the Treatment of Obesity in Adults with Obesity-Related Co-Morbid Conditions

2007 PI – Allen Sussman, MD (Phase 3)

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Safety and Efficacy of An Investigational Medication in the Treatment of Obesity in An Adult Population with BMI>35

2006- PI – Ronald Brazg, MD

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter study Evaluating the Efficacy and Safety of Three Doses of An Investigational Medication in Abdominally Obese Patients with Atherogenic Dylsipidemia.

2006 – PI – Ronald Brazg, MD (Phase IIa)

A Study to Assess the Safety, Tolerability, and Efficacy of An Investigational Medication in Obese Patients

2006 – PI – Ronald Brazg, MD (Phase 2)

Study to Assess the Efficacy and Tolerability of An Investigational Medication in Maintaining Weight Loss Induced by Diet in Obese Patients

2006 – PI – Leslie Klaff, MD, Ph.D. (Phase IV)

Effect on Weight Loss of An Approved Medication vs. Placebo in Subjects with Type 2 Diabetes Participating in a Lifestyle Modification Program.

2006 – PI – Leslie Klaff, MD, Ph.D (Phase III)

A 1-Year, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of An Investigational Medication in the Treatment of Overweight, Oral Agent-Treated Subjects with Type 2 Diabetes Mellitus.

2006 – PI – Leslie Klaff, MD, Ph.D (Phase III)

A 2-Year, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of An Investigational Medication in the Treatment of Obese Subjects.

2005- (Phase III) PI – Ronald Brazg, MD

Randomized, multicenter, double-blind, placebo-controlled, two-arm parallel group trail of rimonabant 20-mg od, for inhibitor of atherosclerosis progression assessed by carotid artery intima-media thickness (CIMT), in overweight patients with additional risk factors.

2005 –PI – Ronald Brazg, MD (Phase II)

A Double-Blind, Multicenter Randomized Parallel Group, 16-Week Study of An Investigational Medication Administered Orally Once A Day With or Without a Low Calorie Diet Lead –In Obese Males and Females

2005 – PI – Ronald Brazg, MD (Phase Ib)

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of An Investigational Nasal Spray in Obese Patients

2005 – PI – Leslie Klaff, MD,Ph.D (Phase IIa)

A Dose Titration Study to Assess the Efficacy, Safety and Tolerability of An Investigational Medication in Obese Patients

2005 – PI – Allen Sussman, MD (Phase III)

A Two-Year Study (One Year Weight Loss followed by One Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of An Investigational Medication in Obese Patients

2004 – PI – Ronald Brazg, MD (Phase IIa)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Assess the Efficacy and Safety of an investigational medication in the Treatment of Obese, Type 2 Diabetic Subjects Managed with Diet or Metformin.

2004 –PI – Ronald Brazg, MD (Phase IIa)

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of an investigational medication in Obese Patients

2003 – Ronald Brazg, MD (Phase III)

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of an investigational medication in Obese Patients

2003 – PI – Ronald Brazg, MD (Phase III)

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of an investigational medication in Maintaining Weight Loss Induced by a Very Low Calorie Diet in Obese Patients

2002 –PI – Ronald Brazg, MD (Phase IIa)

A dose range-finding, double-blind, randomized, placebo-controlled, multicenter study to assess the safety, tolerability, and efficacy of an investigational medication in obese subjects

2001 PI – Ronald Brazg, MD

A Phase III, Multicenter, Two-Arm Study to Assess the Efficacy and Safety of An Investigational Oral Medication in the Treatment of Obesity in Subjects With Hypertension and/or Dyslipidemia

2001 PI – Ronald Brazg, MD

A Phase III, 12-month, double blind, randomized, parallel group, placebo controlled, efficacy and safety study of an investigational medication in overweight and obese subjects with a 12-month open-label extension phase.

2001 PI – Allen Sussman, MD

An Investigational Medication Dose-Response, Efficacy, and Safety: A 12-Week Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group Study of Metformin and Five Doses of an Investigational Medication in Previously Treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

2001 PI – Allen Sussman, MD

A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, multicenter study of weight-reducing and prevention of weight regain effects and safety of an investigational drug in obese patients with or without comorbidities.

1999 PI – Ronald Brazg, MD

A Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Four Doses of an Investigational Medication in Obese Patients

1999 PI – Allen M. Sussman, MD

A Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Safety and Efficacy of Subcutaneously Administered A-300 in Obese Subjects.

1996 PI – Ronald Brazg, MD

A Fifty-Two Week, Multicenter, Double-blind, Placebo-Controlled, Parallel-Group Study to Compare the Effects of an Investigational Medication With Those of Placebo in Mild to Moderate Obese Patients Whose Hypertension is Controlled by a Calcium-Channel Blocker, With or Without Concomitant Thiazide Diuretic Therapy.

1992-1993 PI – Allen Sussman, MD

Evaluation of an investigational medication Versus Placebo for Gallstone Prophylaxis During Very Low Calorie Diet-Induced Rapid Weight Loss

Attention Deficit Hyperactivity Disorder (Pediatric)

1997 PI – John Dunne, MD

A Double-Blind Flexible Dose Study of a Transdermal Investigative Medication in the Treatment of Children with Attention-Deficit Hyperactivity Disorder.

Asthma and COPD

2014 –PI- William Park, MD (Phase 3)

A Phase III, 52 Week, Randomized, Double-Blind, 3-Arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination With the Fixed Dose Dual Combination, All Administered Once-Daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease.

2013 –PI- William Park, MD (Phase 3b)

A Randomized, Multicenter, Double Blind, Double Dummy, Parallel Group Study to Evaluate the Efficacy and Safety of An Investigational Combination Inhalation Powder Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects with COPD

2012 –PI – William Park, MD (Phase 3)

A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of An Investigational Inhalation Powder Once Daily Compared with Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

2004 – PI – William Park, MD (Phase II)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study of Efficacy and Safety of an investigational medication for Inhalation in Adults with Chronic Obstructive Pulmonary Disease

2004 – PI – William Park, MD (Phase II)

A Four-Week, Double-Blind, Placebo-Controlled Exploratory Evaluation of FEV Changes and Safety of an investigational medication in Patients with Chronic Obstructive Pulmonary Disease (COPD).

2003 – William Park, MD (Phase II)

A Double-Blind, Randomized, Multicenter, Two-Part, Parallel-Group, Dose-Ranging Study of Twice-Daily and Once-Daily investigational medication in the Treatment of Subjects with Chronic Obstructive Pulmonary Disease (COPD

1997 PI – Mary Horan, MD

A Multicenter, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety , Tolerability and Efficacy of an Investigational Medication for Four Weeks in Out-Patients with Chronic Obstructive Pulmonary Disease

1995-1996 PI – Steven McClean, MD

A Comparison Study of Adding an Investigational Medication Versus Doubling the Dose of Beclovent in Asthmatic Subjects Symptomatic on Existing Inhaled Corticosteriods.

Chronic Pain

2013 – PI – Allen Sussman, MD (Phase 2)

A Four-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of A Novel Investigational Medication in Subjects with Osteoarthritis of the Knee

2013 – PI – Leslie Klaff, MD, Ph D (Phase 2b)

A Randomized, Double-Blind, Placebo- and Active- Controlled Study to Evaluate the Safety and Efficacy of An Investigational Medication in Patients with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

2010 – PI – Leslie Klaff, MD, Ph D (Phase 2a)

A Phase 2A Randomized Double-Blinded, Placebo and Active Controlled Two Cohort Two Doses Cross-Over Multi-Center Clinical Study to Assess Efficacy of a Once Daily Administration of an Investigational Medication for the Treatment of Vasospasm in Primary and Secondary Raynaud’s Phenomenon.

2009 PI – Allen Sussman, MD (Phase IIb)

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of An Investigational Medication as Adjunctive Therapy in Subjects with Inadequately Controlled, Moderate to Severe, Chronic, Low Back Pain.

2009 PI – Allen Sussman, MD (Phase II)

A Multicenter, Randomized, Double-Blind, Long Term Study of the Safety of Subcutaneous Administration of An Investigational Medication in Patients with Osteoarthritis of the Knee or Hip

2008 PI – Barry Bockow, MD (Phase IIIb)

Randomized, Double Blind, Parallel Group, Placebo Controlled Multicenter Study Evaluating the Efficacy of An Investigational Medication BID and Celecoxib 300 mg QD in Patients with Osteoarthritis of the Knee

2007 PI – Leslie Klaff, MD, Ph D (Phase II)

A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial of An Investigational Medicated Tape for Treatment of Chronic Low Back Pain

2006 – PI Leslie Klaff, MD, PhD (Phase III)

Phase II Dose-Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503 in the Treatment of Raynauds Phenomenon

2006 – PI – Allen Sussman, MD (Phase III)

A Randomized, Double-Blind, Active Control, Parallel Arm, 90 Day Safety Study of An Investigational Medication Immediate Release (IR) or Oxycodone IR in Subjects with Chronic Pain from Low Back Pain (LBP) or Osteoarthritis (OA) of the Hip or Knee.

2005 –PI – Leslie Klaff, MD, PhD (Phase II)

A Multicenter, Two-Phase, Randomized, Enriched, Enrollment, Double-Blind, Vehicle-Controlled Trial of An Investigational Medication Tape for the Treatment of Pain Due to Carpal Tunnel Syndrome and its Symptoms

2005 – PI – Allen Sussman, MD (Phase IV)

Double-Blind, Parallel-Group, Randomized, Study of the Efficacy and Safety of Continuous Use of Celecoxib vs. the “Usual Use” of Celecoxib in the Treatment of Subjects with Chronic Osteoarthritis of the Hip or Knee Who Require An Anti-Inflammatory Medication for Control of the Their Pain

2004 –PI – Allan Sussman, MD (Phase IIb)

A 4-Week Randomized, Multicenter, Double-blind, Placebo-and Active-controlled, Parallel – group, Forced-titration Phase IIB Study Comparing the Efficacy and Safety of Ascending Doses of an investigational medication and Oxycodone Prolonged release up to 20 mg BID to Placebo in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthrits of the Knee

2003 – PI- Allen Sussman, MD (Phase IV)

A randomized, multiple-dose, double-blind, placebo-controlled, parallel-group study comparing the safety and efficacy of an investigational medication and Duragesic in subjects with Non-Malignany Pain.

2003 – PI-Allen Sussman, MD (Phase 2)

Safety Evaluation of an investigational medication in Opioid Tolerant Patients

1998 PI – Allen Sussman, MD

A Multicenter, Open-Label Study Evaluating the Safety and Tolerability of Tramadol Hydrochloride Controlled-Release Tables in Patients With Chronic Pain.

Bacteria Vaginosis

1995-1996 PI – John Vander Heyden, MD

An Open-Label, Randomized, Controlled, Multi-Center Clinical Trial to Evaluate an Investigational Medication Compared to Cleocin in the Treatment of Bacterial Vaginosis.

Depression

1995-1996 PI – Barnett Kaplan, MD

A Placebo-Controlled Trial of an Investigational Medication and Fluoxetine (Prozac) in the Treatment of Patients with Major Depression

Cardiac Studies

2012 –PI – Gerald Lorch, MD (Phase 3)

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of An Investigational Medication Versus Ezetimibe in High Cardiovascular Risk Patients with Hypercholesterolemia Not Adequately Controlled with their Statin Therapy

2011 –  PI – Gerald Lorch, MD (Phase II)

A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Trial of A Quarterly Subcutaneous Investigational Medication in the Prevention of Recurrent Cardiovascular Events Among Stable Post-Myocardial Infarction Patients With Elevated hsCRP

2010 – PI – Gerald Lorch, MD (Phase II)

A Phase II, Open-Label, Dose Exposure Confirmation Study to Evaluate the Pharmacokinetics and Safety and Tolerability of An Investigational Medication in Adult Patients with Non-Valvular Atrial Fibrillation or Atrial Flutter

2009 PI – Leslie Klaff, MD, Ph D (Phase III)

A Clinical Outcomes Study of An Investigational Medication Versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

2009 PI – Leslie Klaff, MD, Ph D (Phase II)

A Phase II Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Evaulation of the Efficacy and Safety of An Investigational Medication by High Resolution Magnetic Resonance Imaging (MRI) in Carotid Atherosclerotic Plaque

2008 PI – Terrance A. Block, MD (Phase III)

A Phase 3, Randomized, Double Blind, Double Dummy, Parallel Group, Multicenter, Multinational Study for Evaluation of Efficacy and Safety of An Investigational Medication Versus Warfarin In Subjects with Atrial Fibrillation – Effective aNticoaGulation with factor xA next Generation in Atrial Fibrillation (ENGAGE-AF)

1998 PI – Terrance Block, MD

A Phase II Double-blind, Placebo-Controlled, Randomized Efficacy Study of an Investigational Medication in Patients Undergoing Direct Percutaneous Transluminar Coronary Angioplasty Following Acute Myocardial Infarction

1997 PI – Allen Sussman, MD

A Multicenter, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety , Tolerability and Efficacy of an Investigational Medication for Four Weeks in Out-Patients with Chronic Obstructive Pulmonary Disease.

1995-1996 PI – Terence Block, MD

A Study to Determine the Efficacy and Safety of an Investigational Medication in Non- Q-Wave Coronary Events: A Double-blind, Randomized, Parallel Group, Multicenter Study Comparing an Investigational Medication and Intravenous Unfractionated Heparin