Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Saxagliptin

Criteria

Inclusion Criteria:

• Diagnosed with type 2 diabetes

• Documented history of CrCl <50 ml/min within the 3 months prior to enrollment

• HbA1c ≥7.0% and ≤11.0%

Exclusion Criteria:

• Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma

• Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.