A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

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

Details

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

Criteria

Inclusion Criteria:

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

• Drug naive or treated with anti-diabetic medication for < 24 weeks

• C-peptide ≥ 1.0 ng/mL

• Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

• AST and/or ALT > 3 times ULN

• Serum total bilirubin > 2 mg/dL

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

• Creatine kinase ≥ 3 times ULN

• Symptoms of severely uncontrolled diabetes

• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases