Status:
COMPLETED
Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
572 Patients enrolled
Trial Details
Trial ID
NCT00614939
Start Date
January 1 2008
End Date
March 1 2010
Last Update
May 19 2011
Active Locations (74)
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1
Research Site
Concord, California, United States
2
Research Site
Sacramento, California, United States
3
Research Site
Denver, Colorado, United States
4
Research Site
Topeka, Kansas, United States