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:

ClinicalTrials.gov Identifier:

NCT00035542

First Posted: May 6, 2002

Last Update Posted: April 15, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Bristol-Myers Squibb

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 Glyburide

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	9 Years to 16 Years (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


ClinicalTrials.gov Identifier:	NCT00035542 History of Changes
Other Study ID Numbers:	CV138-059
First Submitted:	May 3, 2002
First Posted:	May 6, 2002
Last Update Posted:	April 15, 2011
Last Verified:	April 2011

Keywords provided by Bristol-Myers Squibb:


Diabetes Mellitus, Type II

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Metformin Glyburide Hypoglycemic Agents Physiological Effects of Drugs

To Top