DIABETES - TYPE 1

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

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.

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

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 - 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 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.
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.

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.

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.