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 Glycemi

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Metformin; Saxagliptin

Criteria

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