An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Astra Zeneca, Bristol-Myers Squibb
• Treatments: Dapagliflozin; Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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