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

NCT ID: NCT00035568

Last Updated: 2011-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2003-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Non-Insulin-Dependent

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Glucovance (metformin HCl/glyburide)

Intervention Type DRUG

or Metformin HCl alone

Intervention Type DRUG

or Glyburide alone.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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%
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Little Rock, Arkansas, United States

Site Status

Local Institution

Los Angeles, California, United States

Site Status

Local Institution

Chicago, Illinois, United States

Site Status

Local Institution

Indianapolis, Indiana, United States

Site Status

Local Institution

Brooklyn, New York, United States

Site Status

Local Institution

Rochester, New York, United States

Site Status

Local Institution

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution

Dallas, Texas, United States

Site Status

Local Institution

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.

Reference Type DERIVED
PMID: 32501595 (View on PubMed)

Other Identifiers

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CV138-062

Identifier Type: -

Identifier Source: org_study_id

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