A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.

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.

Intervention(s) in this Clinical Trial

• Drug: Glucovance (metformin HCl/glyburide)
• Drug: metformin HCl
• Drug: glyburide

• 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

Lead Investigator: Bristol-Myers Squibb Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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