PPAR - Combination With Metformin

Condition(s) targeted: Diabetes Mellitus

Intervention: Muraglitazar (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Local Institution, Buenos Aires, Argentina

Local Institution, Cordoba, Argentina

Local Institution, Mendoza, Argentina

Local Institution, Albens, France

Local Institution, Broglie, France

Local Institution, Chartres, France

Local Institution, Fabregues, France

Local Institution, Gemenos, France

Local Institution, Husseren Wesserling, France

Local Institution, Labarthe Sur Leze, France

Local Institution, Rosiers D'Egletons, France

Local Institution, Seoul, Korea, Republic of

Local Institution, Distrito Federal, Mexico

Local Institution, Durango, Mexico

Local Institution, Arequipa, Peru

Local Institution, Lima, Peru

Local Institution, Anasco, Puerto Rico

Local Institution, Carolina, Puerto Rico

Local Institution, Guaynabo, Puerto Rico

Local Institution, Ponce, Puerto Rico

Local Institution, Rio Piedras, Puerto Rico

Local Institution, Angelholm, Sweden

Local Institution, Bjuv, Sweden

Local Institution, Enskede, Sweden

Local Institution, Farsta, Sweden

Local Institution, Gothenburg, Sweden

Local Institution, Helsingborg, Sweden

Local Institution, Jarfalla, Sweden

Local Institution, Landskrona, Sweden

Local Institution, Leksand, Sweden

Local Institution, Linkoping, Sweden

Local Institution, Malmo, Sweden

Local Institution, Odeshog, Sweden

Local Institution, Savedalen, Sweden

Local Institution, Sjuntorp, Sweden

Local Institution, Stockholm, Sweden

Local Institution, Trollhattan, Sweden

Local Institution, Vallingby, Sweden

Local Institution, Swan Lake, United Kingdom

Local Institution, Anniston, Alabama, United States

Local Institution, Birmingham, Alabama, United States

Local Institution, Haleyville, Alabama, United States

Local Institution, Mobile, Alabama, United States

Local Institution, Calgary, Alberta, Canada

Local Institution, Carrickfergus, Antrim, United Kingdom

Local Institution, Mesa, Arizona, United States

Local Institution, Phoenix, Arizona, United States

Local Institution, Tucson, Arizona, United States

Local Institution, Fayette, Arkansas, United States

Local Institution, Little Rock, Arkansas, United States

Local Institution, Tijuana, Baja California, Mexico

Local Institution, Coquitlam, British Columbia, Canada

Local Institution, Bahia Blanca, Buenos Aires, Argentina

Local Institution, Concord, California, United States

Local Institution, Fountain Valley, California, United States

Local Institution, La Jolla, California, United States

Local Institution, Los Angeles, California, United States

Local Institution, Los Gatos, California, United States

Local Institution, Mission Viejo, California, United States

Local Institution, Pasadena, California, United States

Local Institution, Rolling Hills Estate, California, United States

Local Institution, Roseville, California, United States

Local Institution, San Diego, California, United States

Local Institution, Spring Valley, California, United States

Local Institution, Walnut Creek, California, United States

Local Institution, Soham, Cambridgeshire, United Kingdom

Local Institution, Buenos Aires, Capital Federal, Argentina

Local Institution, Colorado Springs, Colorado, United States

Local Institution, Denver, Colorado, United States

Local Institution, Littleton, Colorado, United States

Local Institution, Loveland, Colorado, United States

Local Institution, Wheat Ridge, Colorado, United States

Local Institution, New Britain, Connecticut, United States

Local Institution, Newark, Delaware, United States

Local Institution, Wilmington, Delaware, United States

Local Institution, Doncaster, Derbyshire, United Kingdom

Local Institution, Paignton, Devon, United Kingdom

Local Institution, Mexico, Distrito Federal, Mexico

Local Institution, Bangor, Down, United Kingdom

Local Institution, Downpatrick, Down, United Kingdom

Local Institution, Bexhill-On-Sea, East Sussex, United Kingdom

Local Institution, High Valleyfield, Fife, United Kingdom

Local Institution, Chipley, Florida, United States

Local Institution, Cooper City, Florida, United States

Local Institution, Kissimmee, Florida, United States

Local Institution, Melbourne, Florida, United States

Local Institution, Miami, Florida, United States

Local Institution, New Port Richey, Florida, United States

Local Institution, Ocala, Florida, United States

Local Institution, Orlando, Florida, United States

Local Institution, Winter Park, Florida, United States

Local Institution, Columbus, Georgia, United States

Local Institution, Dunwoody, Georgia, United States

Local Institution, Sunbury on Thames, Greater London, United Kingdom

Local Institution, Leon, Guanajuato, Mexico

Local Institution, Aldershot, Hampshire, United Kingdom

Local Institution, Honolulu, Hawaii, United States

Local Institution, Overland Park, Kansas, United States

Local Institution, Shawnee Mission, Kansas, United States

Local Institution, Wichita, Kansas, United States

Local Institution, Louisville, Kentucky, United States

Local Institution, Richmond, Kentucky, United States

Local Institution, Glasgow, Lanarkshire, United Kingdom

Local Institution, Blackpool, Lancashire, United Kingdom

Local Institution, Farnworth, Lancashire, United Kingdom

Local Institution, SLidell, Louisiana, United States

Local Institution, Winnipeg, Manitoba, Canada

Local Institution, Chester, Maryland, United States

Local Institution, Silver Spring, Maryland, United States

Local Institution, Ayer, Massachusetts, United States

Local Institution, Springfield, Massachusetts, United States

Local Institution, Sudbury, Massachusetts, United States

Local Institution, Lansing, Michigan, United States

Local Institution, Harrow, Middlesex, United Kingdom

Local Institution, Arden Hills, Minnesota, United States

Local Institution, Gulfport, Mississippi, United States

Local Institution, Olive Branch, Mississippi, United States

Local Institution, Rolling Fork, Mississippi, United States

Local Institution, Excelsior Springs, Missouri, United States

Local Institution, Kansas City, Missouri, United States

Local Institution, Springfield, Missouri, United States

Local Institution, St.Louis, Missouri, United States

Local Institution, St. Peters, Missouri, United States

Local Institution, Cuernavaca, Morelos, Mexico

Local Institution, Omaha, Nebraska, United States

Local Institution, Toms River, New Jersey, United States

Local Institution, Albuquerque, New Mexico, United States

Local Institution, Canberra, New South Wales, Australia

Local Institution, Sydney, New South Wales, Australia

Local Institution, Wollongong, New South Wales, Australia

Local Institution, Buffalo, New York, United States

Local Institution, New Hyde Park, New York, United States

Local Institution, West Seneca, New York, United States

Local Institution, Westfield, New York, United States

Local Institution, Manuels, Newfoundland and Labrador, Canada

Local Institution, ST. John's, Newfoundland and Labrador, Canada

Local Institution, Charlotte, North Carolina, United States

Local Institution, Durham, North Carolina, United States

Local Institution, Greensboro, North Carolina, United States

Local Institution, Greenville, North Carolina, United States

Local Institution, Hickory, North Carolina, United States

Local Institution, High Point, North Carolina, United States

Local Institution, Huntersville, North Carolina, United States

Local Institution, Salisbury, North Carolina, United States

Local Institution, Wilmington, North Carolina, United States

Local Institution, Winston Salem, North Carolina, United States

Local Institution, Doncaster, North Yorkshire, United Kingdom

Local Institution, Halifax, Nova Scotia, Canada

Local Institution, Monterrey, Nuevo Leon, Mexico

Local Institution, Cincinnati, Ohio, United States

Local Institution, Oklahoma City, Oklahoma, United States

Local Institution, Tulsa, Oklahoma, United States

Local Institution, Oakville, Ontario, Canada

Local Institution, Ottawa, Ontario, Canada

Local Institution, Thornhill, Ontario, Canada

Local Institution, Toronto, Ontario, Canada

Local Institution, Corvallis, Oregon, United States

Local Institution, Eugene, Oregon, United States

Local Institution, Hillsboro, Oregon, United States

Local Institution, Portland, Oregon, United States

Local Institution, Belem, Para, Brazil

Local Institution, Curitiba, Parana, Brazil

Local Institution, Philadelphia, Pennsylvania, United States

Local Institution, Warminster, Pennsylvania, United States

Local Institution, Chicoutimi, Quebec, Canada

Local Institution, Fleurimont, Quebec, Canada

Local Institution, Granby, Quebec, Canada

Local Institution, Laval, Quebec, Canada

Local Institution, Longueuil, Quebec, Canada

Local Institution, Montreal, Quebec, Canada

Local Institution, Pointe-Claire, Quebec, Canada

Local Institution, Sherbrooke, Quebec, Canada

Local Institution, Brisbane, Queensland, Australia

Local Institution, Meadowbrook, Queensland, Australia

Local Institution, Cranston, Rhode Island, United States

Local Institution, Porto Alegre, Rio Grande do Sul, Brazil

Local Institution, Saskatoon, Saskatchewan, Canada

Local Institution, Duncan, South Carolina, United States

Local Institution, Greer, South Carolina, United States

Local Institution, Simpsonville, South Carolina, United States

Local Institution, Hastings, Sussex, United Kingdom

Local Institution, Bristol, Tennessee, United States

Local Institution, Kingsport, Tennessee, United States

Local Institution, Memphis, Tennessee, United States

Local Institution, Dallas, Texas, United States

Local Institution, Houston, Texas, United States

Local Institution, Irving, Texas, United States

Local Institution, Lake Jackson, Texas, United States

Local Institution, Lubbock, Texas, United States

Local Institution, San Antonio, Texas, United States

Local Institution, Salt Lake City, Utah, United States

Local Institution, Springfield, Virginia, United States

Local Institution, Virginia Beach, Virginia, United States

Local Institution, Atherstone, Warwickshire, United Kingdom

Local Institution, Nuneaton, Warwickshire, United Kingdom

Local Institution, Olympia, Washington, United States

Local Institution, Renton, Washington, United States

Local Institution, Spokane, Washington, United States

Local Institution, Perth, Western Australia, Australia

Local Institution, bath, Wiltshire, United Kingdom

Local Institution, Milwaukee, Wisconsin, United States

Local Institution, Inkberrow, Worcestershire, United Kingdom

Local Institution, Merida, Yucatan, Mexico

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2003
Last updated: September 27, 2007