PK Study of Dapagliflozin in Pediatric Subjects With T2DM

A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

Primary purpose: The primary purpose is to assess the pharmacokinetics of a single dose of Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with T2DM

Inclusion Criteria:

• Clinical diagnosis of T2DM
• Male and female subjects ages 10-17
• Glycosylated Hemoglobin A1c (HbA1c) ≥6 to 10%
• Body weight ≥30 kg

Exclusion Criteria:

• Fasting plasma glucose (FPG) >240 mg/dL at screening
• Abnormal renal function
• Active liver disease and/or significant abnormal liver function