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:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00035542

First received: May 3, 2002

Last updated: April 7, 2011

Last verified: April 2011

History of Changes

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:

Drug Information available for: Metformin Metformin hydrochloride Glyburide

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:


Study Start Date:	December 2001
Study Completion Date:	October 2003
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035542

Show 50 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases	Glyburide Metformin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015

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