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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01434186
First received: September 13, 2011
Last updated: October 17, 2016
Last verified: October 2016
  Purpose
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Mean change in Glycosylated hemoglobin (HbA1c) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in 2-hour Postprandial Glucose (PPG) Area under the curve (AUC) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • Mean change in FPG (Fasting plasma glucose) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • Percent of subjects with HbA1c < 7% in the short term treatment period [ Time Frame: At Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: May 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   10 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434186

  Show 69 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01434186     History of Changes
Other Study ID Numbers: CV181-147  2010-024568-16 
Study First Received: September 13, 2011
Last Updated: October 17, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Central Drugs Standard Control Organization
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: Swedish Data Inspection Board
Sweden: Swedish National Council on Medical Ethics
Taiwan: Department of Health
Taiwan: National Bureau of Controlled Drugs
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016