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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

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ClinicalTrials.gov Identifier: NCT01434186
Recruitment Status : Completed
First Posted : September 14, 2011
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo matching with Saxagliptin Drug: Metformin IR Drug: Metformin XR Drug: Saxagliptin Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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U.S. FDA Resources

Arms and Interventions
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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 Name: BMS-477118
Placebo Comparator: Arm 2: Placebo +Metformin XR/IR
Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
 Drug: Placebo matching with Saxagliptin
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change in HbA1c From Baseline to Week 16 [ Time Frame: 16 week short term treatment period ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434186


Locations
United States, California
Research Site
Los Angeles, California, United States
United States, Florida
Research Site
Tallahassee, Florida, United States
United States, Michigan
Research Site
Dearborn, Michigan, United States
United States, Minnesota
Research Site
St. Paul, Minnesota, United States
United States, New York
Research Site
Mineola, New York, United States
United States, Ohio
Research Site
Cleveland, Ohio, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
Belgium
Research Site
Namur, Belgium
Canada, Alberta
Research Site
Calgary, Alberta, Canada
India
Research Site
Bangalore, India
Mexico
Research Site
Aguascalientes, Mexico
Research Site
Meridas, Mexico
Research Site
Monterrey, Mexico
Research Site
Veracruz, Mexico
Taiwan
Research Site
Taichung, Taiwan
United Kingdom
Research Site
Leicester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01434186     History of Changes
Other Study ID Numbers: CV181-147
2010-024568-16 ( EudraCT Number )
First Posted: September 14, 2011    Key Record Dates
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action