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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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035568
First received: May 3, 2002
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Study Start Date: February 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00035568     History of Changes
Other Study ID Numbers: CV138-062
Study First Received: May 3, 2002
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

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
 Glyburide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013