PK Study of Dapagliflozin in Pediatric Subjects With T2DM
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 11/8/2014 |
| Start Date: | July 2012 |
| End Date: | August 2014 |
| Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: |
| Email: | Clinical.Trials@bms.com |
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
The purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in
pediatric subjects with type 2 diabetes mellitus (T2DM)
pediatric subjects with type 2 diabetes mellitus (T2DM)
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
Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with
T2DM
Inclusion Criteria:
- Clinical diagnosis of T2DM
- Male and female subjects ages 10-17
- Glycosylated Hemoglobin A1c (HbA1c) >6 to <10%
Exclusion Criteria:
- Fasting plasma glucose (FPG) >240 mg/dL at screening
- Abnormal renal function
- Active liver disease and/or significant abnormal liver function
We found this trial at
15
sites
Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Mercy Children's Hospital Mercy Children's Hospital is a regional resource for advanced pediatric care located...
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