Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief summary:
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

Detailed description:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy

Arms:
arm 1: Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg arm 2: Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg

Interventions: intervention 1: Placebo matching with Saxagliptin intervention 2: Metformin IR intervention 3: Metformin XR intervention 4: Saxagliptin
Intervention descriptions: intervention 1: Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52 intervention 2: Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52 intervention 3: Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52 intervention 4: Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)

Protocol document: