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

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