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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin/Metformin XR FDC; Drug: Saxagliptin; Drug: Metformin immediate release (IR); Drug: Metformin IR; Drug: Metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01525225

CV181-153

Details and patient eligibility

About

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

Full description

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 following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets

Enrollment: 4 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

4 participants in 1 patient group

Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC

Experimental group

Treatment:

Drug: Metformin XR

Drug: Metformin IR

Drug: Metformin immediate release (IR)

Drug: Saxagliptin

Drug: Saxagliptin/Metformin XR FDC