PK Study of Dapagliflozin in Pediatric Subjects With T2DM

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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