A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

NCT00295633 Phase 3 COMPLETED Results posted

The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	565
Start date	2006-03
Completion	2008-10

Conditions

• Diabetes Mellitus, Type 2

Interventions

• Saxagliptin
• Saxagliptin
• Placebo
• pioglitazone
• rosiglitazone
• metformin

Primary outcomes

• Change From Baseline in Hemoglobin A1c (A1C) at Week 24 — Baseline, Week 24
  Mean change from baseline in A1C at Week 24, adjusted for baseline value.

Countries

United States, Argentina, Canada, India, Mexico, Peru, Philippines, Puerto Rico