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

NCT ID: NCT00035542

Last Updated: 2011-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2003-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Non-Insulin-Dependent

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Glucovance (metformin HCl/glyburide)

Intervention Type DRUG

metformin HCl

Intervention Type DRUG

glyburide

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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%
Minimum Eligible Age

9 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Childrens's Health System/Dept of PED/Diabetes/Endoncrinology

Birmingham, Alabama, United States

Site Status

Advanced Clinical Therapeutics

Tucson, Arizona, United States

Site Status

Hazan, Lydie

Beverly Hills, California, United States

Site Status

Bautista Research & Medical Center

Fresno, California, United States

Site Status

Health Care Link, Inc

La Jolla, California, United States

Site Status

Neufeld Medical Group

Los Angeles, California, United States

Site Status

National Institute Of Clinical Research

Los Angeles, California, United States

Site Status

Pasadena Pediatric Endocrinology Diabetes

Pasadena, California, United States

Site Status

A.R.I. Clinical Trials

Redondo Beach, California, United States

Site Status

Sutter Institute For Medical Research

Sacramento, California, United States

Site Status

Children's Hospital

Denver, Colorado, United States

Site Status

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

EDU Practice Pediatric Endocrinology

Tallahassee, Florida, United States

Site Status

Southeastern Endocrine and Diabetes

Atlanta, Georgia, United States

Site Status

University of Hawaii/Diabetes Research Group

‘Ewa Beach, Hawaii, United States

Site Status

St. James Diabetes Center

Chicago Heights, Illinois, United States

Site Status

Lutheran General Children's Hospital

Park Ridge, Illinois, United States

Site Status

Raymond Blank Children's Hospital

Des Moines, Iowa, United States

Site Status

Louisville Metabolic & Athersclerosis Research Center/Advanced Cardiovascular Institute

Louisville, Kentucky, United States

Site Status

Bay East Endocrinologists

Easton, Maryland, United States

Site Status

Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

JM Clinical Trials Inc

Swansea, Massachusetts, United States

Site Status

Center for Health Management

Gulfport, Mississippi, United States

Site Status

Medex Healthcare Research

St Louis, Missouri, United States

Site Status

Diabetes, Endocrine & Nutrition Core Physicians

Hampton, New Hampshire, United States

Site Status

Hackensack Medical Center

Hackensack, New Jersey, United States

Site Status

Endocrine & Diabetes Center

Jersey City, New Jersey, United States

Site Status

SUNY Downstate Medical Center / Dept of Endocrinology

Brooklyn, New York, United States

Site Status

Children's Hospital of Buffalo/Kaledia Health Diabetes Center

Buffalo, New York, United States

Site Status

Winthrop University Hospital, Clinical Trials Center

Mineola, New York, United States

Site Status

St Luke's Roosevelt Hospital/Westside Pediatrics Assoc/Clinical Pharmacology Program

New York, New York, United States

Site Status

Vassar Brothers Hospital

Poughkeepsie, New York, United States

Site Status

University of Rochester/Dpt Pediatrics, S.M.H.

Rochester, New York, United States

Site Status

Montefioe Medical Center - DIV / c/o BRANY

The Bronx, New York, United States

Site Status

East Carolina University School of Medicine Dept of Pediatrics

Greenville, North Carolina, United States

Site Status

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status

Metro Health Medical Center

Cleveland, Ohio, United States

Site Status

The Cleveland Clinic Children's Hospital/Dept of Pediatrics

Cleveland, Ohio, United States

Site Status

Forum Health/Western Reserve/TOD Children's Hospital

Youngstown, Ohio, United States

Site Status

Greenville Hospital System/Mountain View Clinical Research/Div of Pediatric Endocrinology

Greenville, South Carolina, United States

Site Status

Lebonheur Children's Medical Center

Memphis, Tennessee, United States

Site Status

South Texas Applied Research

Corpus Christi, Texas, United States

Site Status

Driscoll Children's Hospital/Division of Medical Education/William Riley

Corpus Christi, Texas, United States

Site Status

Tri Quest Research Inc

Houston, Texas, United States

Site Status

Wilford Hall USAF Medical Center

Lackland Air Force Base, Texas, United States

Site Status

Lance Sloan, MD

Lufkin, Texas, United States

Site Status

Diabetes & Glandular Disease Clinic

San Antonio, Texas, United States

Site Status

S.A.M. Clinical Research Center

San Antonio, Texas, United States

Site Status

Monarch Research Associates

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CV138-059

Identifier Type: -

Identifier Source: org_study_id

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