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Dose Ranging Study With LT, Monotherapy, PPAR

NCT ID: NCT00240383

Last Updated: 2010-09-14

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

PHASE2/PHASE3

Total Enrollment

1260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2006-06-30

Brief Summary

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A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes

Detailed Description

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Conditions

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Diabetes Mellitus II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Muraglitazar

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. HbA1c \> 7.0% and ≤ 10.0% obtained at the Screening visit.
* 2\. Men and women, 18-70 years of age Established Type 2 diabetes

Exclusion Criteria

* 1\. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months.
* 2\. Administration of antihyperglycemic agents (other than thiazolidinediones) for more than three consecutive or a total of seven non-consecutive days during the four weeks prior to screening.
* 3\. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Hot Springs, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Fayette, Arkansas, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Concord, California, United States

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Encinitas, California, United States

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Fair Oaks, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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Los Gatos, California, United States

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Orange, California, United States

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Raleigh, California, United States

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Riverside, California, United States

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Rolling Hills Estate, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Santa Barbara, California, United States

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Spring Valley, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Golden, Colorado, United States

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Littleton, Colorado, United States

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Nederland, Colorado, United States

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Wheat Ridge, Colorado, United States

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New Britain, Connecticut, United States

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Brandon, Florida, United States

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Chipley, Florida, United States

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Coral Gables, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Ocoee, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Tamarac, Florida, United States

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Titusville, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Dunwoody, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Vernon Hills, Illinois, United States

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Arkansas City, Kansas, United States

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Shawnee Mission, Kansas, United States

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Wichita, Kansas, United States

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Bardstown, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Richmond, Kentucky, United States

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Metairie, Louisiana, United States

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Slidell, Louisiana, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Chevy Chase, Maryland, United States

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Norwood, Massachusetts, United States

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Springfield, Massachusetts, United States

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Swansea, Massachusetts, United States

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Worcester, Massachusetts, United States

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Birmingham, Michigan, United States

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Petoskey, Michigan, United States

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Arden Hills, Minnesota, United States

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Bay Saint Louis, Mississippi, United States

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Cleveland, Mississippi, United States

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Jackson, Mississippi, United States

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Olive Branch, Mississippi, United States

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Rolling Fork, Mississippi, United States

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Excelsior Springs, Missouri, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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Camillus, New York, United States

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Endicott, New York, United States

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Johnson City, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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High Point, North Carolina, United States

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Moorehead City, North Carolina, United States

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Raleigh, North Carolina, United States

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Avon, Ohio, United States

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Beavercreek, Ohio, United States

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Bellbrook, Ohio, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Colombus, Ohio, United States

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Lyndhurst, Ohio, United States

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Massillon, Ohio, United States

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Zanesville, Ohio, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Reading, Pennsylvania, United States

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Cranston, Rhode Island, United States

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East Providence, Rhode Island, United States

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Johnston, Rhode Island, United States

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Providence, Rhode Island, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Bristol, Tennessee, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Edmonds, Washington, United States

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Federal Way, Washington, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Walla Walla, Washington, United States

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Madison, Wisconsin, United States

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New Berlin, Wisconsin, United States

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Buenos Aires, Buenos Aires, Argentina

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Chacabuco, Buenos Aires, Argentina

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Mendoza, Mendoza Province, Argentina

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Wollongong, New South Wales, Australia

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Fullerton, South Australia, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Perth, Western Australia, Australia

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Fortaleza, Ceará, Brazil

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Campo Grande, Mato Grosso, Brazil

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Belém, Pará, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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Marília, São Paulo, Brazil

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S. J. Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Taubaté, São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Ottawa, Ontario, Canada

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Drummonville, Quebec, Canada

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Longueuil, Quebec, Canada

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Ottawa, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Brno, CZE, Czechia

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České Budějovice, , Czechia

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Jihlava, , Czechia

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Liberec, , Czechia

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Prague, , Czechia

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Albens, , France

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Orthez, , France

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Rennes, , France

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Rosiers-d'Égletons, , France

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Savigny-en-Véron, , France

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Strasbourg, , France

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Milan, , Italy

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Modena, , Italy

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Roma, , Italy

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Aguascalientes, Aguascalientes, Mexico

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Tijuana, Estado de Baja California, Mexico

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Distrito Federal, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Deventer, , Netherlands

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Ewijk, , Netherlands

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Hengelo, , Netherlands

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Lichtenvoorde, , Netherlands

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Losser, , Netherlands

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Ryswyk, , Netherlands

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Utrecht, , Netherlands

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Gorzów, Wielkopolski, Poland

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Stalowa, Wola, Poland

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Bydgoszcz, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Zielona Góra, , Poland

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Ponce, , Puerto Rico

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San Juan, , Puerto Rico

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Noordheuwel, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Vanderbijlpark, Gauteng, South Africa

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George, Northern Cape, South Africa

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Tygerberg, Western Cape, South Africa

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Santiago, De Compostela, Spain

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Barcelona, ESP, Spain

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Cadiz, ESP, Spain

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Herston, Queensland, Spain

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Girona, , Spain

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Granada, , Spain

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Las Palmas de Gran Canaria, , Spain

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Madrid, , Spain

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Oviedo, , Spain

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Gothenburg, , Sweden

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Helsingborg, , Sweden

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Linköping, , Sweden

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Malmo, , Sweden

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Motala, , Sweden

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Sävedalen, , Sweden

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Stockholm, , Sweden

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Vällingby, , Sweden

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Newtonabbey, Armach, United Kingdom

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Ely, Cambridgeshire, United Kingdom

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Soham, Cambridgeshire, United Kingdom

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Blantyre, Central, United Kingdom

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Chapelhall, Central, United Kingdom

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Paisley, Central, United Kingdom

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Riddrie, Central, United Kingdom

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Cumbernauld, Dumbartonshire, United Kingdom

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Moodiesburn, Dumbartonshire, United Kingdom

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Annan, Dumfries & Galloway, United Kingdom

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Dunscore, Dumfries & Galloway, United Kingdom

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Stranraer, Dumfries & Galloway, United Kingdom

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Moffat, Dumfriesshire, United Kingdom

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Bexhill-on-Sea, East Sussex, United Kingdom

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High Valleyfield, Fife, United Kingdom

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Sunbury-on-Thames, Greater London, United Kingdom

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Caerleon, Gwent, United Kingdom

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Burnbank, Lanarkshire, United Kingdom

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Coatbridge, Lanarkshire, United Kingdom

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Edinburgh, Lothian, United Kingdom

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Hamilton, Lothian, United Kingdom

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Llandough, Mid Glamorgan, United Kingdom

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Pont-y-clun, Mid Glamorgan, United Kingdom

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Neilston, Renfrewshire, United Kingdom

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Paisley, Renfrewshire, United Kingdom

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Kilsyth, Stirlingshire, United Kingdom

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Lanarkshire, Strathclyde, United Kingdom

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East Horsley, Surrey, United Kingdom

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Cookstown, Tyrone, United Kingdom

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Atherstone, Warwickshire, United Kingdom

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Balsall Common, Warwickshire, United Kingdom

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Stratford-upon-Avon, Warwickshire, United Kingdom

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Chelmsley Wod, West Midlands, United Kingdom

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Chippenham, Wiltshire, United Kingdom

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Glasgow, , United Kingdom

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Countries

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United States Argentina Australia Brazil Canada Czechia France Italy Mexico Netherlands Poland Puerto Rico South Africa Spain Sweden United Kingdom

References

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Rubin CJ, Viraswami-Appanna K, Fiedorek FT. Efficacy and safety of muraglitazar: a double-blind, 24-week, dose-ranging study in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Jul;6(3):205-15. doi: 10.1177/1479164109336048.

Reference Type DERIVED
PMID: 20368213 (View on PubMed)

Other Identifiers

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CV168-006

Identifier Type: -

Identifier Source: org_study_id