AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

NCT ID: NCT00241605

Last Updated: 2018-03-21

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

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-25

Study Completion Date

2005-12-16

Brief Summary

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This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rosiglitazone/metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
* Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
* Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.

Exclusion Criteria

* Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
* Have a known hypersensitivity to thiazolidinediones or biguanides.
* Currently using insulin or any oral anti-diabetic agent other than metformin.
* History of metabolic acidosis.
* History of substance abuse.
* Have active cancer other than localized squamous or basal cell carcinoma.
* Chronic disease requiring treatment with corticosteroids.
* Other criteria will be evaluated at the screening visit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Calgary, Alberta, Canada

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GSK Investigational Site

Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Medicine Hat, Alberta, Canada

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Aldergrove, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Fredericton, New Brunswick, Canada

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Houston, New Brunswick, Canada

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Neguac, New Brunswick, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Carbonear, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Dartmouth, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Truro, Nova Scotia, Canada

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Upper Tantallon, Nova Scotia, Canada

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Ajax, Ontario, Canada

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Brampton, Ontario, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Cambridge, Ontario, Canada

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Fort Erie, Ontario, Canada

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Hamilton, Ontario, Canada

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Innisfil, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Mississauga, Ontario, Canada

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North York, Ontario, Canada

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Oakville, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Rexdale, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Sutton, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Woodbridge, Ontario, Canada

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Woodstock, Ontario, Canada

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Woodstock, Ontario, Canada

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Brossard, Quebec, Canada

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Charlesbourg, Quebec, Canada

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Charlesbourg, Quebec, Canada

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Châteauguay, Quebec, Canada

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Courcelette, Quebec, Canada

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Cowansville, Quebec, Canada

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Hull, Quebec, Canada

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Lambton, Quebec, Canada

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Lle Perrot, Quebec, Canada

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Longueuil, Quebec, Canada

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Longueuil, Quebec, Canada

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Longueuil, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Pierrefonds, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Richelieu, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Saint-Jean-sur-Richelieu, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Sainte-Anne-de-Bellevue, Quebec, Canada

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Sainte-Catherine, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sainte-Henri de Levis, Quebec, Canada

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Salaberry-de-Valleyfield, Quebec, Canada

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Thetford-Mines, Quebec, Canada

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Vaudreuil, Quebec, Canada

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Ville Lasalle, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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GSK Investigational Site

Saskatoon, Saskatchewan, Canada

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GSK Investigational Site

Québec, , Canada

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Countries

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Canada

Other Identifiers

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712753/008

Identifier Type: -

Identifier Source: org_study_id

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