Overview

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

Status:
Terminated
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
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) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Metformin
Saxagliptin
Criteria
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