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

April 7, 2011 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (Estimate)

May 6, 2002

Study Record Updates

Last Update Posted (Estimate)

April 15, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV138-059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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