PK Study of Dapagliflozin in Pediatric Subjects with T2DM

Study identifier:MB102-091

ClinicalTrials.gov identifier:NCT01525238

EudraCT identifier:2011-005225-40

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

No

Study drug

Dapagliflozin

Sex

All

Actual Enrollment

53

Study type

Interventional

Age

10 Years - 17 Years

Date

Study Start Date: 01 Jul 2012
Primary Completion Date: 01 Sept 2014
Study Completion Date: 01 Sept 2014

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Apr 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria