A Research Study to Assess the Mechanism By Which Glucovance, Metformin, and Glyburide Work To Control Glucose Levels In Patients With Type 2 Diabetes

The purpose of this clinical research study is to support earlier observations that Glucovance controls glucose levels after a mean, and improves overall glucose control better than metformin or glyburide therapy alone in adults with type 2 diabetes...

Date First Received: May 3, 2002

Last Updated: September 27, 2007

Verified by: Bristol-Myers Squibb, September 2007

Clinical Trial Phase: Phase 4 | Start Date: 

Overall Status: Completed

Brief Summary

The purpose of this clinical research study is to support earlier observations that Glucovance controls glucose levels after a mean, and improves overall glucose control better than metformin or glyburide therapy alone in adults with type 2 diabetes.

Study Type: Interventional

Study Design: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Glucovance (metformin HCl/glyburide)
  • Drug: or Metformin HCl alone
  • Drug: or Glyburide alone.

Criteria for Participation in this Clinical Trial

  • Adults 20-75 with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, and have an HbA1c greater than 6.7%

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 75 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/NCT00035568

Study ID Number: CV138-062

ClinicalTrials.gov Identifier: NCT00035568

Health Authority: United States: Food and Drug Administration

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