Research Projects 2000-2008 (Completed and Ongoing)
March 2008
Oral insulin study
A Five Period, Open Label, Placebo Controlled Study To Evaluate The Safety, Tolerability, Pharmacodynamics And Pharmacokinetics Of A Single Ascending Dose Of IN-105 Under Fed Conditions in T2DM Subjects.
January 2008
Bicifadine study
A Double-blind, Randomized, Placebo-controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients with Chronic Neuropathy Pain associated with Diabetic Peripheral Neuropathy. Study Code: XTL B07- 001.
January 2008
Soluble Insulin Basal Analogue study
A 16 week randomised, open-labelled, four-armed, treat-to-target, parallel-group trial comparing SIBA D once daily, SIBA E once daily, SIBA D Monday, Wednesday and Friday and insulin glargine once daily, all in combination with metformin in subjects with type 2 diabetes failing on OAD treatment.
December 2007
Teplizumab study
A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging
Study to Evaluate Efficacy and Safety of MGA031, a humanized, FcR Non-Binding, Anti-CD3 Monoclonal
Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus.
December 2007
Riviglitazone study
CS0011-A-U301 study: A Randomized Double-blind, Placebo and Active Comparator-Controlled Parallel-group study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type-2 Diabetes Mellitus.
December 2007
DPP inhibitor study
A Randomized, Double-Bind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients with Type 2 Diabetes Inadequately Controlled on Metformin Alone.
November 2007
Viaject study (ultra short acting insulin)
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAJECT™ and Regular Human Insulin in Patients with Type 2 Diabetes Mellitus. VIAJECT 08J, Version: 2, dated October 30, 2006.
November 2007
Viaject study (ultra short acting insulin)
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAJECT™ and Regular Human Insulin in Patients with Type 1 Diabetes Mellitus -06J, Version Date: 02 November 2006, Version no: 3.
November 2006
DPP inhibitor study
Protocol Number: PHX 1149 – PROT 202, A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T in Subjects with Type 2 Diabetes Mellitus
November 2006
Saxagliptin study
Protocol Number: CV 181 039, A Multicenter, Randomized, Dou-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control.
August 2006
Saxagliptin study
Protocol Number: CV 181 013, A Multicenter, Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118)InCombination With Thiazolidinedione Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedine Therapy Alone
June 2006
Liraglutide Study Protocol Number: NN2211-1572, Liraglutide Effect and Action
in Diabetes (LEAD-2): Effect on glycaemic control after once daily administration of liraglutide in combination with metformin versus metformin monotherapy versus metformin and glimepiride combination therapy in subjects with type 2 diabetes.
June 2004
ORIGIN study
(Outcome Reduction with an Initial Glargine Intervention)
