PK Study of Dapagliflozin in Pediatric Subjects With T2DM

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01525238

2011-005225-40 (EudraCT Number)

MB102-091

Details and patient eligibility

About

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

Full description

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

Enrollment: 53 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

Dapagliflozin 2.5 mg

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

Dapagliflozin 5 mg

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

Dapagliflozin 10 mg

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin