Dose Ranging Study With LT, Monotherapy, PPAR
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
1 other identifier
interventional
1,260
16 countries
272
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2002
Typical duration for phase_2
272 active sites
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
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedSeptember 14, 2010
June 1, 2008
4.1 years
October 17, 2005
September 10, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2
Secondary Outcomes (1)
To assess, after 12 and 24 weeks of oral administration of double-blind therapy, the percent change from baseline in fasting lipids (total cholesterol,low density lipoprotein cholesterol,HDL-C, TG, non-HDL chol
Interventions
Eligibility Criteria
You may qualify if:
- \. HbA1c \> 7.0% and ≤ 10.0% obtained at the Screening visit.
- \. Men and women, 18-70 years of age Established Type 2 diabetes
You may not qualify if:
- \. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months.
- \. 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.
- \. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (272)
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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, CearĂ¡, Brazil
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Campo Grande, Mato Grosso, Brazil
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BelĂ©m, ParĂ¡, 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, SĂ£o Paulo, Brazil
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MarĂlia, SĂ£o Paulo, Brazil
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S. J. Rio Preto, SĂ£o Paulo, Brazil
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SĂ£o Paulo, SĂ£o Paulo, Brazil
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TaubatĂ©, SĂ£o 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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ÄŒeskĂ© BudÄ›jovice, 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-VĂ©ron, 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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GorzĂ³w, 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 GĂ³ra, 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
Related Publications (1)
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.
PMID: 20368213DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 18, 2005
Study Start
May 1, 2002
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
September 14, 2010
Record last verified: 2008-06