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.

First Received: May 3, 2002 Last Updated: September 27, 2007 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035542

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 III

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glyburide Glucovance Metformin Metformin hydrochloride

U.S. FDA Resources

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

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

Study ID Numbers:	CV138-059
Study First Received:	May 3, 2002
Last Updated:	September 27, 2007
ClinicalTrials.gov Identifier:	NCT00035542 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Diabetes Mellitus, Type II

Additional relevant MeSH terms:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin

Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009