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.

First Received on May 3, 2002. Last Updated on April 7, 2011 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035568

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 IV

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glyburide Glucovance Metformin Metformin hydrochloride

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 February 12, 2012