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