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:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035542
First received: May 3, 2002
Last updated: April 7, 2011
Last verified: April 2011
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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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035542
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| 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 June 18, 2013