NCT00035568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2002

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

April 15, 2011

Status Verified

April 1, 2011

Enrollment Period

1.3 years

First QC Date

May 3, 2002

Last Update Submit

April 7, 2011

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Keywords

Type 2 Diabetes Mellitus

Interventions

Glucovance (metformin HCl/glyburide)DRUG
or Metformin HCl aloneDRUG
or Glyburide alone.DRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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%

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Local Institution

Little Rock, Arkansas, United States

Location

Local Institution

Los Angeles, California, United States

Location

Local Institution

Chicago, Illinois, United States

Location

Local Institution

Indianapolis, Indiana, United States

Location

Local Institution

Brooklyn, New York, United States

Location

Local Institution

Rochester, New York, United States

Location

Local Institution

Pittsburgh, Pennsylvania, United States

Location

Local Institution

Dallas, Texas, United States

Location

Local Institution

San Antonio, Texas, United States

Location

Related Publications (1)

  • 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.

    PMID: 32501595DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

GlucovanceMetforminGlyburide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsSulfonylurea CompoundsUreaAmidesSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 3, 2002

First Posted

May 6, 2002

Study Start

February 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

April 15, 2011

Record last verified: 2011-04

Locations

US(9)