Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.

Detailed description:

Arms:
arm 1: Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) arm 2: Placebo matching saxagliptin tablet

Interventions: intervention 1: Saxagliptin intervention 2: Placebo (Saxagliptin) intervention 3: Metformin IR intervention 4: Placebo (Metformin) intervention 5: Metformin (Active Rescue)
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks intervention 2: Tablets, Oral, Once daily, 1-16 weeks intervention 3: Tablets, Oral, 500 mg, Once Daily, 17-52 weeks intervention 4: Tablets, Oral, Once daily, 1-16 weeks intervention 5: Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks

Protocol document: