Phase I Multiple-Ascending Dose (Japan)

A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days

Inclusion Criteria:

• Japanese male and female subjects
• Ages 20 to 70 years old
• Established diagnosis of T2DM
• BMI < 32 kg/m2
• Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
• HbA1C 6.0 - 10.0%

Exclusion Criteria:

• Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
• History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
• History of incontinence or bladder dysfunction including nocturia