A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035542
First received: May 3, 2002
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

The purpose of this clinical research study is to see if Glucovance, a medication currently approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and effectively in children 9 to 16 years of age.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Glucovance (metformin HCl/glyburide)
Drug: metformin HCl
Drug: glyburide
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: December 2001
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Children ages 9-16 years with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, with or without oral hypoglycemic therapy, and have an HbA1c greater than 6.4%

  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: NCT00035542

  Hide Study Locations
Locations
United States, Alabama
Childrens's Health System/Dept of PED/Diabetes/Endoncrinology
Birmingham, Alabama, United States, 35233
United States, Arizona
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
United States, California
Hazan, Lydie
Beverly Hills, California, United States, 90211
Bautista Research & Medical Center
Fresno, California, United States, 93721
Health Care Link, Inc
La Jolla, California, United States, 92037
Neufeld Medical Group
Los Angeles, California, United States, 90048
National Institute Of Clinical Research
Los Angeles, California, United States, 90806
Pasadena Pediatric Endocrinology Diabetes
Pasadena, California, United States, 91105
A.R.I. Clinical Trials
Redondo Beach, California, United States, 90277
Sutter Institute For Medical Research
Sacramento, California, United States, 95816
United States, Colorado
Children's Hospital
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
EDU Practice Pediatric Endocrinology
Tallahassee, Florida, United States, 32308
United States, Georgia
Southeastern Endocrine and Diabetes
Atlanta, Georgia, United States, 33028
United States, Hawaii
University of Hawaii/Diabetes Research Group
Ewa Beach, Hawaii, United States, 96706
United States, Illinois
St. James Diabetes Center
Chicago Heights, Illinois, United States, 60411
Lutheran General Children's Hospital
Park Ridge, Illinois, United States, 60068
United States, Iowa
Raymond Blank Children's Hospital
Des Moines, Iowa, United States, 50309
United States, Kentucky
Louisville Metabolic & Athersclerosis Research Center/Advanced Cardiovascular Institute
Louisville, Kentucky, United States, 40217
United States, Maryland
Bay East Endocrinologists
Easton, Maryland, United States, 21601
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
JM Clinical Trials Inc
Swansea, Massachusetts, United States, 02777
United States, Mississippi
Center for Health Management
Gulfport, Mississippi, United States, 39501
United States, Missouri
Medex Healthcare Research
St Louis, Missouri, United States, 63108
United States, New Hampshire
Diabetes, Endocrine & Nutrition Core Physicians
Hampton, New Hampshire, United States, 03842
United States, New Jersey
Hackensack Medical Center
Hackensack, New Jersey, United States, 07601
Endocrine & Diabetes Center
Jersey City, New Jersey, United States, 07306
United States, New York
Montefioe Medical Center - DIV / c/o BRANY
Bronx, New York, United States, 11021
SUNY Downstate Medical Center / Dept of Endocrinology
Brooklyn, New York, United States, 11203
Children's Hospital of Buffalo/Kaledia Health Diabetes Center
Buffalo, New York, United States, 16222
Winthrop University Hospital, Clinical Trials Center
Mineola, New York, United States, 11502
St Luke's Roosevelt Hospital/Westside Pediatrics Assoc/Clinical Pharmacology Program
New York, New York, United States, 10023
Vassar Brothers Hospital
Poughkeepsie, New York, United States, 12603
University of Rochester/Dpt Pediatrics, S.M.H.
Rochester, New York, United States, 14642
United States, North Carolina
East Carolina University School of Medicine Dept of Pediatrics
Greenville, North Carolina, United States, 27858
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Metro Health Medical Center
Cleveland, Ohio, United States, 44109-1998
The Cleveland Clinic Children's Hospital/Dept of Pediatrics
Cleveland, Ohio, United States, 44195
Forum Health/Western Reserve/TOD Children's Hospital
Youngstown, Ohio, United States, 44501
United States, South Carolina
Greenville Hospital System/Mountain View Clinical Research/Div of Pediatric Endocrinology
Greenville, South Carolina, United States, 29615
United States, Tennessee
Lebonheur Children's Medical Center
Memphis, Tennessee, United States, 38106
United States, Texas
South Texas Applied Research
Corpus Christi, Texas, United States, 78411
Driscoll Children's Hospital/Division of Medical Education/William Riley
Corpus Christi, Texas, United States, 78466-6530
Tri Quest Research Inc
Houston, Texas, United States, 77036
Wilford Hall USAF Medical Center
Lackland AFB, Texas, United States, 78236-5300
Lance Sloan, MD
Lufkin, Texas, United States, 75901
Diabetes & Glandular Disease Clinic
San Antonio, Texas, United States, 78229
S.A.M. Clinical Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Monarch Research Associates
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00035542     History of Changes
Other Study ID Numbers: CV138-059
Study First Received: May 3, 2002
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Diabetes Mellitus, Type II

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glyburide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014