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

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

Detailed Description
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Placebo matching with Saxagliptin
* Drug: Metformin IR
* Drug: Metformin XR
* Drug: Saxagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Saxagliptin +Metformin XR/IR<br>Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg | Drug: Metformin IR<br>* Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52<br>Drug: Metformin XR<br>* Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52<br>Drug: Saxagliptin<br>* Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)<br>* Other names: BMS-477118;|
| Placebo Comparator: Arm 2: Placebo +Metformin XR/IR<br>Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg | Drug: Placebo matching with Saxagliptin<br>* Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52<br>Drug: Metformin IR<br>* Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52<br>Drug: Metformin XR<br>* Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in HbA1c From Baseline to Week 16 |  | 16 week short term treatment period |