Status:
COMPLETED
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Astra Zeneca, Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
Eligibility Criteria
Inclusion
- Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit
- Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment
- C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
- BMI ≤ 45.0 kg/m2
Exclusion
- Urine albumin to creatinine ratio (UACR) \> 1,800 mg/g (203.4 mg/mmol/Cr)
- Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
- Alanine aminotransferase (ALT) \> 3X ULN
- Serum Total Bilirubin \> 2 mg/dL (34.2 μmol/l)
- Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00831779
Start Date
April 1 2009
End Date
August 1 2010
Last Update
April 24 2017
Active Locations (3)
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1
Va San Diego Healthcare System
San Diego, California, United States, 92161
2
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
3
Temple University General Clinical Research Center
Philadelphia, Pennsylvania, United States, 19140