Status:
COMPLETED
An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-77 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Dia...
Eligibility Criteria
Inclusion
- Males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
- Drug naive or treated with anti-diabetic medication for \< 24 weeks since original diagnosis
- C-peptide ≥ 1.0 ng/mL
- Body Mass Index ≤ 45.0 kg/m
- Serum creatinine \< 1.50 mg/dL for men or \< 1.40 mg/dL for women
Exclusion
- AST and/or ALT \>3.0 times the upper limit of normal (ULN)
- Serum total bilirubin \> 2.0 mg/dL
- Creatine kinase \> 3X the upper limit of normal (ULN)
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
994 Patients enrolled
Trial Details
Trial ID
NCT00643851
Start Date
June 1 2008
End Date
August 1 2009
Last Update
January 30 2023
Active Locations (99)
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1
Greystone Medical Research, Llc
Birmingham, Alabama, United States, 35242
2
Winston Technology Research, Llc
Haleyville, Alabama, United States, 35565
3
Clinical Research Advantage, Inc.
Tempe, Arizona, United States, 85282
4
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520