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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Non-Insulin-Dependent

Intervention: Glucovance (metformin HCl/glyburide) (Drug); metformin HCl (Drug); glyburide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Summary

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.

Clinical Details

Study design: Primary Purpose: Treatment

Eligibility

Minimum age: 9 Years. Maximum age: 16 Years. Gender(s): Both.

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%

Locations and Contacts

Childrens's Health System/Dept of PED/Diabetes/Endoncrinology, Birmingham, Alabama 35233, United States

Advanced Clinical Therapeutics, Tucson, Arizona 85712, United States

Hazan, Lydie, Beverly Hills, California 90211, United States

Bautista Research & Medical Center, Fresno, California 93721, United States

Health Care Link, Inc, La Jolla, California 92037, United States

National Institute Of Clinical Research, Los Angeles, California 90806, United States

Neufeld Medical Group, Los Angeles, California 90048, United States

Pasadena Pediatric Endocrinology Diabetes, Pasadena, California 91105, United States

A.R.I. Clinical Trials, Redondo Beach, California 90277, United States

Sutter Institute For Medical Research, Sacramento, California 95816, United States

Children's Hospital, Denver, Colorado 80218, United States

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States

Children's National Medical Center, Washington, District of Columbia 20010, United States

EDU Practice Pediatric Endocrinology, Tallahassee, Florida 32308, United States

Southeastern Endocrine and Diabetes, Atlanta, Georgia 33028, United States

University of Hawaii/Diabetes Research Group, Ewa Beach, Hawaii 96706, United States

St. James Diabetes Center, Chicago Heights, Illinois 60411, United States

Lutheran General Children's Hospital, Park Ridge, Illinois 60068, United States

Raymond Blank Children's Hospital, Des Moines, Iowa 50309, United States

Louisville Metabolic & Athersclerosis Research Center/Advanced Cardiovascular Institute, Louisville, Kentucky 40217, United States

Bay East Endocrinologists, Easton, Maryland 21601, United States

Joslin Diabetes Center, Boston, Massachusetts 02215, United States

JM Clinical Trials Inc, Swansea, Massachusetts 02777, United States

Center for Health Management, Gulfport, Mississippi 39501, United States

Medex Healthcare Research, St Louis, Missouri 63108, United States

Diabetes, Endocrine & Nutrition Core Physicians, Hampton, New Hampshire 03842, United States

Hackensack Medical Center, Hackensack, New Jersey 07601, United States

Endocrine & Diabetes Center, Jersey City, New Jersey 07306, United States

Montefioe Medical Center - DIV / c/o BRANY, Bronx, New York 11021, United States

SUNY Downstate Medical Center / Dept of Endocrinology, Brooklyn, New York 11203, United States

Children's Hospital of Buffalo/Kaledia Health Diabetes Center, Buffalo, New York 16222, United States

Winthrop University Hospital, Clinical Trials Center, Mineola, New York 11502, United States

St Luke's Roosevelt Hospital/Westside Pediatrics Assoc/Clinical Pharmacology Program, New York, New York 10023, United States

Vassar Brothers Hospital, Poughkeepsie, New York 12603, United States

University of Rochester/Dpt Pediatrics, S.M.H., Rochester, New York 14642, United States

East Carolina University School of Medicine Dept of Pediatrics, Greenville, North Carolina 27858, United States

Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States

Metro Health Medical Center, Cleveland, Ohio 44109-1998, United States

The Cleveland Clinic Children's Hospital/Dept of Pediatrics, Cleveland, Ohio 44195, United States

Forum Health/Western Reserve/TOD Children's Hospital, Youngstown, Ohio 44501, United States

Greenville Hospital System/Mountain View Clinical Research/Div of Pediatric Endocrinology, Greenville, South Carolina 29615, United States

Lebonheur Children's Medical Center, Memphis, Tennessee 38106, United States

Driscoll Children's Hospital/Division of Medical Education/William Riley, Corpus Christi, Texas 78466-6530, United States

South Texas Applied Research, Corpus Christi, Texas 78411, United States

Tri Quest Research Inc, Houston, Texas 77036, United States

Wilford Hall USAF Medical Center, Lackland AFB, Texas 78236-5300, United States

Lance Sloan, MD, Lufkin, Texas 75901, United States

Diabetes & Glandular Disease Clinic, San Antonio, Texas 78229, United States

S.A.M. Clinical Research Center, San Antonio, Texas 78229, United States

Monarch Research Associates, Norfolk, Virginia 23510, United States

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2001
Last updated: April 7, 2011

Page last updated: August 23, 2015

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