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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Saxagliptin; Drug: Metformin XR; Drug: Metformin IR; Drug: Placebo matching with Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01434186

2010-024568-16 (EudraCT Number)

CV181-147

Details and patient eligibility

About

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

Full 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

Enrollment: 32 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Arm 1: Saxagliptin +Metformin XR/IR

Experimental group

Description:

Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg

Treatment:

Drug: Metformin XR

Drug: Metformin IR

Drug: Saxagliptin

Arm 2: Placebo +Metformin XR/IR

Placebo Comparator group

Description:

Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg

Treatment:

Drug: Metformin XR

Drug: Metformin IR

Drug: Placebo matching with Saxagliptin