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

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ClinicalTrials.gov Identifier: NCT00035568
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: Glucovance (metformin HCl/glyburide) Drug: or Metformin HCl alone Drug: or Glyburide alone. Phase 4

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : February 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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%
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00035568


Locations
United States, Arkansas
Local Institution
Little Rock, Arkansas, United States
United States, California
Local Institution
Los Angeles, California, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Indiana
Local Institution
Indianapolis, Indiana, United States
United States, New York
Local Institution
Brooklyn, New York, United States
Local Institution
Rochester, New York, United States
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States
United States, Texas
Local Institution
Dallas, Texas, United States
Local Institution
San Antonio, Texas, United States
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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: NCT00035568     History of Changes
Other Study ID Numbers: CV138-062
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by Bristol-Myers Squibb:
Type 2 Diabetes Mellitus

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