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

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