Status:
COMPLETED
PK Study of Dapagliflozin in Pediatric Subjects With T2DM
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
10-17 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)
Detailed 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
Eligibility Criteria
Inclusion
- Clinical diagnosis of T2DM
- Male and female subjects ages 10-17
- Glycosylated Hemoglobin A1c (HbA1c) ≥6 to 10%
- Body weight ≥30 kg
Exclusion
- Fasting plasma glucose (FPG) \>240 mg/dL at screening
- Abnormal renal function
- Active liver disease and/or significant abnormal liver function
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01525238
Start Date
July 1 2012
End Date
September 1 2014
Last Update
May 30 2017
Active Locations (17)
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1
The Children Hospital Of Alabama
Birmingham, Alabama, United States, 35233
2
Axis Clinical Trials
Los Angeles, California, United States, 90036
3
Nemours Childrens Hospital
Orlando, Florida, United States, 32827
4
Emory University
Atlanta, Georgia, United States, 30322