A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

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

Details

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

Criteria

Key Inclusion Criteria

• Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control

• Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks

• C-peptide ≥1.0 ng/mL

• Body mass index ≤45.0 kg/m^2

• Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

• Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal

• Serum total bilirubin level >2 mg/dL

• Creatinine kinase level >3 times upper limit of normal

• Symptoms of severely uncontrolled diabetes

• Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women

• Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases