PK Study of Dapagliflozin in Pediatric Subjects With T2DM

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT01525238

Run by

AstraZeneca

People needed

53

Starts

2012-07-01

Expected to finish

2014-09-01

Last updated by the study team

2017-05-30

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• The Children Hospital Of Alabama — Birmingham, Alabama, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Nemours Childrens Hospital — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
• Lsuhsc-Shreveport — Shreveport, Louisiana, United States
• Childrens Mercy Hospital — Kansas City, Missouri, United States
• Women And Children'S Hopsital Of Buffalo — Buffalo, New York, United States
• Promedica Toledo Children'S Hospital — Toledo, Ohio, United States
• Mercy Children'S Hospital — Toledo, Ohio, United States
• Children'S Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States
• Children'S Hospital Of Pittsburgh Of Upmc — Pittsburgh, Pennsylvania, United States
• Methodist Le Bonheur Hlthcare — Memphis, Tennessee, United States
• Christus Santa Rosa Childrens Hospital — San Antonio, Texas, United States
• Local Institution — Guadalajara, Jalisco, Mexico
• Local Institution — Monterrey, Nuevo León, Mexico
• Local Institution — Veracruz, Mexico

Full record on ClinicalTrials.gov

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