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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Metformin IR; Drug: Metformin XR; Drug: Saxagliptin; Drug: Placebo matching with Saxagliptin

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Namur, Belgium
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Research Site
• India
  • Bangalore, India
    • Research Site
• Mexico
  • Aguascalientes, Mexico
    • Research Site
  • Meridas, Mexico
    • Research Site
  • Monterrey, Mexico
    • Research Site
  • Veracruz, Mexico
    • Research Site
• Taiwan
  • Taichung, Taiwan
    • Research Site
• United Kingdom
  • Leicester, United Kingdom
    • Research Site
• United States
  • California
    • Los Angeles, California, United States
      • Research Site
  • Florida
    • Tallahassee, Florida, United States
      • Research Site
  • Michigan
    • Dearborn, Michigan, United States
      • Research Site
  • Minnesota
    • St. Paul, Minnesota, United States
      • Research Site
  • New York
    • Mineola, New York, United States
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (Estimate): September 14, 2011

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Saxagliptin
• Other Study ID Numbers: CV181-147; 2010-024568-16 (EudraCT Number)