Status:
COMPLETED
Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment
Detailed Description
All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as nee...
Eligibility Criteria
Inclusion
- Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
- Clinical diagnosis of moderate renal impairment
Exclusion
- AST and /or ALT \> 3.0 times the upper limit of normal
- Serum total bilirubin \> 1.5 times ULN
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
631 Patients enrolled
Trial Details
Trial ID
NCT00663260
Start Date
June 1 2008
End Date
June 1 2011
Last Update
February 10 2017
Active Locations (96)
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1
Vista Medical Research, Inc.
Mesa, Arizona, United States, 85206
2
Valley Research
Fresno, California, United States, 93720
3
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States, 94904
4
Office Of Richard Cherlin, Md
Los Gatos, California, United States, 95032