Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 17
Updated:5/5/2014
Start Date:February 2013
End Date:July 2014
Contact:For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email:Clinical.Trials@bms.com

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Trial Summary
Trial Overview
Inclusion Criteria

Evaluation of the Pharmacokinetics of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus Following Oral Administration of Saxagliptin and Metformin XR Fixed Dose Combination Tablet and Co-Administration of Saxagliptin and Glucophage® (Metformin) IR Tablets

The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy
Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM)

The primary purpose is to assess the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin,
and Metformin in pediatric subjects aged 10 to 17 years with T2DM

Inclusion Criteria:

- Clinical diagnosis of T2DM

- Male and female subjects ages 10-17

- Body weight ≥50 kg

- Glycosylated hemoglobin (HbA1c) 6.5 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
10
sites
Children's Hospital of Pittsburgh of UPMC
4401 Penn Avenue
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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Kansas City, Missouri 64108
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Osborne Research Center
Little Rock, Arkansas 72201
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Los Angeles, California 90095
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Louisville, Kentucky 40202
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Neptune, New Jersey 07753
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Philadelphia, Pennsylvania 19102
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Seattle, Washington 98109
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Toledo, Ohio 43606
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Local Institution
Toledo, Ohio 43606
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