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Completed

NCT Number: NCT01434186

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Namur, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo matching with Saxagliptin

Drug

Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52

Metformin IR

Drug

Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52

Metformin XR

Drug

Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52

Saxagliptin

Drug

Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)

Other names: BMS-477118

Primary outcomes

  1. Mean Change in HbA1c From Baseline to Week 16

    Time frame: 16 week short term treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2011
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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