Diabetes MellitusPhase 3NCT00162240

PPAR - Combination With Metformin

A Phase 3 study testing Muraglitazar in people with Diabetes Mellitus, run by Bristol-Myers Squibb at 203 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Muraglitazar
How many people: 534 participants
Where: 203 sitesin 12 countries
Study dates: Jun 2003to May 2004
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 Diabetes
HbA1c > - 7.0% and < - 10.0 %
Mean serum triglyceride < - 600 mg/dL
Body mass index < - 41 kg/m2
Fasting c-peptide > - 1.0 ng/mL

Who cannot join

History of myocardial infarction (MI)
coronary angioplasty or bypass graft(s)
valvular disease or repair
unstable angina pectoris
transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months
Congestive heart failure NYHA Class III and IV
Uncontrolled hypertension
History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease

Trial locations and contacts

203 sites in 12 countries.

Country

City, postcode or hospital

203 sites in 12 countries

United States108 sites

Local Institution
Albuquerque, New Mexico
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Anniston, Alabama
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Arden Hills, Minnesota
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Ayer, Massachusetts
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Birmingham, Alabama
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Bristol, Tennessee
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Buffalo, New York
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Charlotte, North Carolina
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Chester, Maryland
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Chipley, Florida
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Cincinnati, Ohio
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City of Saint Peters, Missouri
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Colorado Springs, Colorado
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Columbus, Georgia
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Concord, California
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Cooper City, Florida
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Corvallis, Oregon
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Cranston, Rhode Island
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Dallas, Texas
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Denver, Colorado
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Duncan, South Carolina
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Dunwoody, Georgia
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Durham, North Carolina
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Eugene, Oregon
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Excelsior Springs, Missouri
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Fayette, Arkansas
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Fountain Valley, California
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Greensboro, North Carolina
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Greenville, North Carolina
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Greer, South Carolina
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Gulfport, Mississippi
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Haleyville, Alabama
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Hickory, North Carolina
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High Point, North Carolina
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Hillsboro, Oregon
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Honolulu, Hawaii
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Houston, Texas
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Huntersville, North Carolina
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Irving, Texas
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Kansas City, Missouri
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Kingsport, Tennessee
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Kissimmee, Florida
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La Jolla, California
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Lake Jackson, Texas
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Lansing, Michigan
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Little Rock, Arkansas
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Littleton, Colorado
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Los Angeles, California
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Los Gatos, California
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Louisville, Kentucky
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Loveland, Colorado
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Lubbock, Texas
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Melbourne, Florida
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Memphis, Tennessee
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Mesa, Arizona
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Miami, Florida
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Milwaukee, Wisconsin
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Mission Viejo, California
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Mobile, Alabama
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New Britain, Connecticut
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New Hyde Park, New York
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New Port Richey, Florida
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Newark, Delaware
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Ocala, Florida
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Oklahoma City, Oklahoma
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Olive Branch, Mississippi
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Olympia, Washington
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Omaha, Nebraska
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Orlando, Florida
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Overland Park, Kansas
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Pasadena, California
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Portland, Oregon
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Renton, Washington
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Richmond, Kentucky
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Rolling Fork, Mississippi
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Rolling Hills Estate, California
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Roseville, California
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Salisbury, North Carolina
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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Shawnee Mission, Kansas
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Silver Spring, Maryland
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Simpsonville, South Carolina
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Slidell, Louisiana
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Spokane, Washington
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Spring Valley, California
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Springfield, Massachusetts
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Springfield, Missouri
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Springfield, Virginia
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St Louis, Missouri
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Sudbury, Massachusetts
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Toms River, New Jersey
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Tucson, Arizona
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Tulsa, Oklahoma
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Virginia Beach, Virginia
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Walnut Creek, California
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Warminster, Pennsylvania
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West Seneca, New York
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Westfield, New York
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Wheat Ridge, Colorado
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Wichita, Kansas
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Wilmington, Delaware
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Wilmington, North Carolina
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Winston-Salem, North Carolina
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Winter Park, Florida

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United Kingdom21 sites

Local Institution
Aldershot, Hampshire
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Atherstone, Warwickshire
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Bangor, Down
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Bath, Wiltshire
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Bexhill-on-Sea, East Sussex
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Blackpool, Lancashire
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Carrickfergus, Antrim
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Doncaster, Derbyshire
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Doncaster, North Yorkshire
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Downpatrick, Down
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Farnworth, Lancashire
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Glasgow, Lanarkshire
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Harrow, Middlesex
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Hastings, Sussex
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High Valleyfield, Fife
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Inkberrow, Worcestershire
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Nuneaton, Warwickshire
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Paignton, Devon
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Soham, Cambridgeshire
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Sunbury-on-Thames, Greater London
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Swan Lake

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Canada19 sites

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Calgary, Alberta
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Chicoutimi, Quebec
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Coquitlam, British Columbia
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Fleurimont, Quebec
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Granby, Quebec
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Halifax, Nova Scotia
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Laval, Quebec
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Longueuil, Quebec
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Manuels, Newfoundland and Labrador
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Montreal, Quebec
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Oakville, Ontario
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Ottawa, Ontario
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Pointe-Claire, Quebec
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Saskatoon, Saskatchewan
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Sherbrooke, Quebec
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St. John's, Newfoundland and Labrador
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Thornhill, Ontario
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Toronto, Ontario
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Winnipeg, Manitoba

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Sweden17 sites

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Ängelholm
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Bjuv
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Enskede
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Färsta
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Gothenburg
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Helsingborg
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Jarfalla
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Landskrona
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Leksand
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Linköping
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Malmö
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Ödeshög
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Sävedalen
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Sjuntorp
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Stockholm
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Trollhättan
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Vällingby

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France8 sites

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Albens
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Broglie
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Chartres
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Fabrègues
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Gémenos
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Husseren-Wesserling
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Labarthe-sur-Lèze
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Rosiers-d'Égletons

Other trials in France

Mexico8 sites

Local Institution
Cuernavaca, Morelos
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Distrito Federal, Mexico City
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Durango, Durango
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León, Guanajuato
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Mérida, Yucatán
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Mexico City, Mexico City
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Monterrey, Nuevo León
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Tijuana, Estado de Baja California

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Australia6 sites

Local Institution
Brisbane, Queensland
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Canberra, New South Wales
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Meadowbrook, Queensland
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Perth, Western Australia
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Sydney, New South Wales
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Wollongong, New South Wales

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Argentina5 sites

Local Institution
Bahía Blanca, Buenos Aires
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Buenos Aires, Buenos Aires
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Buenos Aires, Buenos Aires F.D.
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Córdoba, Córdoba Province
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Mendoza, Mendoza Province

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Puerto Rico5 sites

Local Institution
Anasco
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Carolina
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Guaynabo
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Ponce
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Rio Piedras

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Brazil3 sites

Local Institution
Belém, Pará
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Curitiba, Paraná
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Porto Alegre, Rio Grande do Sul

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Peru2 sites

Local Institution
Arequipa, Arequipa
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Lima, Lima Province

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South Korea1 site

Local Institution
Seoul

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About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Conditions: Diabetes Mellitus
Being tested: Muraglitazar
Keywords: Metabolics Diabetes New Onset
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MuraglitazarDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin

Secondary outcomes (1)

change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2003May 2004

First posted13 Sep 2005 (estimated)
Study startJun 2003
Study completionMay 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 534 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00162240
Sponsor's protocol ID: CV168-022
Status last verified: Apr 2012
First submitted: 9 Sep 2005
Last updated: 27 Apr 2012
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
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Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
ClinicalTrials.gov ID: NCT00162240
Acronym / sponsor ID: CV168-022
Conditions: Diabetes Mellitus
Keywords: Metabolics Diabetes New Onset
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 534 participants
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Jun 2003
Study completion: May 2004 (actual)
First posted: 13 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Type 2 Diabetes
HbA1c > - 7.0% and < - 10.0 %
Mean serum triglyceride < - 600 mg/dL
Body mass index < - 41 kg/m2
Fasting c-peptide > - 1.0 ng/mL

Key exclusion criteria (8 listed)

History of myocardial infarction (MI)
coronary angioplasty or bypass graft(s)
valvular disease or repair
unstable angina pectoris
transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Muraglitazar	Drug	–

Primary outcome

compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin

1 secondary outcome

change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.

Related trials for Diabetes Mellitus

Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

203 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Muraglitazar in people with Diabetes Mellitus, run by Bristol-Myers Squibb at 203 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 203 sites in United States, United Kingdom, Canada, Sweden, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00162240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.