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

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

sites

Osborne Research Center

Little Rock, Arkansas 72201

from

Little Rock, AR