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

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

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

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

Inclusion Criteria:

• Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
• Previously diagnosed as having type 2 diabetes
• HbA1c ≥7.0% and ≤10.5%
• Body weight ≥ 30 kg
• Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
• Women must have a negative serum or urine pregnancy test
• Women must not be breastfeeding

Exclusion Criteria:

• Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)
• Fasting plasma glucose (FPG) > 255 mg/dL
• Diabetic ketoacidosis (DKA) within 6 months of study entry
• Abnormal renal function
• Active liver disease
• Anemia
• An abnormal Thyroid Stimulating Hormone (TSH)
• Creatinine kinase (CK) ≥ 3X ULN