Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01204775
First received: September 16, 2010
Last updated: July 23, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
Drug: Saxagliptin
Drug: Placebo (Saxagliptin)
Drug: Metformin IR
Drug: Placebo (Metformin)
Drug: Metformin (Active Rescue)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) as Monotherapy in Pediatric Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare after 16 weeks of oral double-blind treatment the change from baseline in HbA1c achieved with Saxagliptin and placebo [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the AUC change from baseline in 2-hour PPG levels, as determined from samples obtained during Mixed Meal Tolerance Test (MMTT). [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
    Area under the curve (AUC), Postprandial Glucose (PPG)

  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the change from baseline in Fasting Plasma Glucose (FPG). [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the percent of subjects who achieved Glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: June 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saxagliptin or Placebo Drug: Saxagliptin
Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks
Other Names:
  • BMS-477118
  • Onglyza
Drug: Placebo (Saxagliptin)
Tablets, Oral, 0 mg, Once daily, 1-52 weeks
Active Comparator: Metformin IR or Placebo Drug: Metformin IR
Tablets, Oral, 500 mg, Once Daily, 17-52 weeks
Drug: Placebo (Metformin)
Tablets, Oral, 0 mg, Once daily, 1-52 weeks
Metformin IR
Active Rescue
Drug: Metformin (Active Rescue)
Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
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 32 weeks of age at the time of randomization.
  • HbA1c ≥7.0% and ≤10.5%

Exclusion Criteria:

  • Current use of anti-diabetic medications or use within the specified timeframe prior to screening.
  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: NCT01204775

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 74 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01204775     History of Changes
Other Study ID Numbers: CV181-058, 2010-020360-38
Study First Received: September 16, 2010
Last Updated: July 23, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
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: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
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 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
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014