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...
Date First Received: May 3, 2002
Last Updated: September 27, 2007
Verified by: Bristol-Myers Squibb, September 2007
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Completed
Brief Summary
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment
Intervention(s) in this Clinical Trial
- Drug: Glucovance (metformin HCl/glyburide)
- Drug: metformin HCl
- Drug: glyburide
Criteria for Participation in this Clinical Trial
- 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%
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 9 Years
Maximum Age for this Clinical Trial: 16 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00035542
Study ID Number: CV138-059
ClinicalTrials.gov Identifier: NCT00035542
Health Authority: United States: Food and Drug Administration
BMS Clinical Trials Disclosure
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
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Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
