NCT00035542

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2001

Geographic Reach
1 country

50 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

April 15, 2011

Status Verified

April 1, 2011

Enrollment Period

1.8 years

First QC Date

May 3, 2002

Last Update Submit

April 7, 2011

Conditions

Keywords

Diabetes Mellitus, Type II

Interventions

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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%

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (50)

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

Birmingham, Alabama, 35233, United States

Location

Advanced Clinical Therapeutics

Tucson, Arizona, 85712, United States

Location

Hazan, Lydie

Beverly Hills, California, 90211, United States

Location

Bautista Research & Medical Center

Fresno, California, 93721, United States

Location

Health Care Link, Inc

La Jolla, California, 92037, United States

Location

Neufeld Medical Group

Los Angeles, California, 90048, United States

Location

National Institute Of Clinical Research

Los Angeles, California, 90806, United States

Location

Pasadena Pediatric Endocrinology Diabetes

Pasadena, California, 91105, United States

Location

A.R.I. Clinical Trials

Redondo Beach, California, 90277, United States

Location

Sutter Institute For Medical Research

Sacramento, California, 95816, United States

Location

Children's Hospital

Denver, Colorado, 80218, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

EDU Practice Pediatric Endocrinology

Tallahassee, Florida, 32308, United States

Location

Southeastern Endocrine and Diabetes

Atlanta, Georgia, 33028, United States

Location

University of Hawaii/Diabetes Research Group

‘Ewa Beach, Hawaii, 96706, United States

Location

St. James Diabetes Center

Chicago Heights, Illinois, 60411, United States

Location

Lutheran General Children's Hospital

Park Ridge, Illinois, 60068, United States

Location

Raymond Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

Louisville Metabolic & Athersclerosis Research Center/Advanced Cardiovascular Institute

Louisville, Kentucky, 40217, United States

Location

Bay East Endocrinologists

Easton, Maryland, 21601, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

JM Clinical Trials Inc

Swansea, Massachusetts, 02777, United States

Location

Center for Health Management

Gulfport, Mississippi, 39501, United States

Location

Medex Healthcare Research

St Louis, Missouri, 63108, United States

Location

Diabetes, Endocrine & Nutrition Core Physicians

Hampton, New Hampshire, 03842, United States

Location

Hackensack Medical Center

Hackensack, New Jersey, 07601, United States

Location

Endocrine & Diabetes Center

Jersey City, New Jersey, 07306, United States

Location

SUNY Downstate Medical Center / Dept of Endocrinology

Brooklyn, New York, 11203, United States

Location

Children's Hospital of Buffalo/Kaledia Health Diabetes Center

Buffalo, New York, 16222, United States

Location

Winthrop University Hospital, Clinical Trials Center

Mineola, New York, 11502, United States

Location

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

New York, New York, 10023, United States

Location

Vassar Brothers Hospital

Poughkeepsie, New York, 12603, United States

Location

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

Rochester, New York, 14642, United States

Location

Montefioe Medical Center - DIV / c/o BRANY

The Bronx, New York, 11021, United States

Location

East Carolina University School of Medicine Dept of Pediatrics

Greenville, North Carolina, 27858, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Metro Health Medical Center

Cleveland, Ohio, 44109-1998, United States

Location

The Cleveland Clinic Children's Hospital/Dept of Pediatrics

Cleveland, Ohio, 44195, United States

Location

Forum Health/Western Reserve/TOD Children's Hospital

Youngstown, Ohio, 44501, United States

Location

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

Greenville, South Carolina, 29615, United States

Location

Lebonheur Children's Medical Center

Memphis, Tennessee, 38106, United States

Location

South Texas Applied Research

Corpus Christi, Texas, 78411, United States

Location

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

Corpus Christi, Texas, 78466-6530, United States

Location

Tri Quest Research Inc

Houston, Texas, 77036, United States

Location

Wilford Hall USAF Medical Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Lance Sloan, MD

Lufkin, Texas, 75901, United States

Location

Diabetes & Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

S.A.M. Clinical Research Center

San Antonio, Texas, 78229, United States

Location

Monarch Research Associates

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

GlucovanceMetforminGlyburide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsSulfonylurea CompoundsUreaAmidesSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 3, 2002

First Posted

May 6, 2002

Study Start

December 1, 2001

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

April 15, 2011

Record last verified: 2011-04

Locations