PPAR - Combination With Metformin

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Muraglitazar

• Study Type: Interventional
• Enrollment: 534
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Local Institution
  • Cordoba, Argentina
    • Local Institution
  • Mendoza, Argentina
    • Local Institution
  • Buenos Aires
    • Bahia Blanca, Buenos Aires, Argentina
      • Local Institution
  • Capital Federal
    • Buenos Aires, Capital Federal, Argentina
      • Local Institution
• Australia
  • New South Wales
    • Canberra, New South Wales, Australia
      • Local Institution
    • Sydney, New South Wales, Australia
      • Local Institution
    • Wollongong, New South Wales, Australia
      • Local Institution
  • Queensland
    • Brisbane, Queensland, Australia
      • Local Institution
    • Meadowbrook, Queensland, Australia
      • Local Institution
  • Western Australia
    • Perth, Western Australia, Australia
      • Local Institution
• Brazil
  • Para
    • Belem, Para, Brazil
      • Local Institution
  • Parana
    • Curitiba, Parana, Brazil
      • Local Institution
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Local Institution
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Local Institution
  • British Columbia
    • Coquitlam, British Columbia, Canada
      • Local Institution
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Local Institution
  • Newfoundland and Labrador
    • Manuels, Newfoundland and Labrador, Canada
      • Local Institution
    • ST. John's, Newfoundland and Labrador, Canada
      • Local Institution
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Local Institution
  • Ontario
    • Oakville, Ontario, Canada
      • Local Institution
    • Ottawa, Ontario, Canada
      • Local Institution
    • Thornhill, Ontario, Canada
      • Local Institution
    • Toronto, Ontario, Canada
      • Local Institution
  • Quebec
    • 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
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Local Institution
• France
  • 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
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Local Institution
• Mexico
  • Distrito Federal, Mexico
    • Local Institution
  • Durango, Mexico
    • Local Institution
  • Baja California
    • Tijuana, Baja California, Mexico
      • Local Institution
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico
      • Local Institution
  • Guanajuato
    • Leon, Guanajuato, Mexico
      • Local Institution
  • Morelos
    • Cuernavaca, Morelos, Mexico
      • Local Institution
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico
      • Local Institution
  • Yucatan
    • Merida, Yucatan, Mexico
      • Local Institution
• Peru
  • Arequipa, Peru
    • Local Institution
  • Lima, Peru
    • Local Institution
• Puerto Rico
  • 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
• Sweden
  • 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
• United Kingdom
  • Swan Lake, United Kingdom
    • Local Institution
  • Antrim
    • Carrickfergus, Antrim, United Kingdom
      • Local Institution
  • Cambridgeshire
    • Soham, Cambridgeshire, United Kingdom
      • Local Institution
  • Derbyshire
    • Doncaster, Derbyshire, United Kingdom
      • Local Institution
  • Devon
    • Paignton, Devon, United Kingdom
      • Local Institution
  • Down
    • Bangor, Down, United Kingdom
      • Local Institution
    • Downpatrick, Down, United Kingdom
      • Local Institution
  • East Sussex
    • Bexhill-On-Sea, East Sussex, United Kingdom
      • Local Institution
  • Fife
    • High Valleyfield, Fife, United Kingdom
      • Local Institution
  • Greater London
    • Sunbury on Thames, Greater London, United Kingdom
      • Local Institution
  • Hampshire
    • Aldershot, Hampshire, United Kingdom
      • Local Institution
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom
      • Local Institution
  • Lancashire
    • Blackpool, Lancashire, United Kingdom
      • Local Institution
    • Farnworth, Lancashire, United Kingdom
      • Local Institution
  • Middlesex
    • Harrow, Middlesex, United Kingdom
      • Local Institution
  • North Yorkshire
    • Doncaster, North Yorkshire, United Kingdom
      • Local Institution
  • Sussex
    • Hastings, Sussex, United Kingdom
      • Local Institution
  • Warwickshire
    • Atherstone, Warwickshire, United Kingdom
      • Local Institution
    • Nuneaton, Warwickshire, United Kingdom
      • Local Institution
  • Wiltshire
    • Bath, Wiltshire, United Kingdom
      • Local Institution
  • Worcestershire
    • Inkberrow, Worcestershire, United Kingdom
      • Local Institution
• United States
  • Alabama
    • Anniston, Alabama, United States
      • Local Institution
    • Birmingham, Alabama, United States
      • Local Institution
    • Haleyville, Alabama, United States
      • Local Institution
    • Mobile, Alabama, United States
      • Local Institution
  • Arizona
    • Mesa, Arizona, United States
      • Local Institution
    • Phoenix, Arizona, United States
      • Local Institution
    • Tucson, Arizona, United States
      • Local Institution
  • Arkansas
    • Fayette, Arkansas, United States
      • Local Institution
    • Little Rock, Arkansas, United States
      • Local Institution
  • California
    • 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
  • Colorado
    • 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
  • Connecticut
    • New Britain, Connecticut, United States
      • Local Institution
  • Delaware
    • Newark, Delaware, United States
      • Local Institution
    • Wilmington, Delaware, United States
      • Local Institution
  • Florida
    • 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
  • Georgia
    • Columbus, Georgia, United States
      • Local Institution
    • Dunwoody, Georgia, United States
      • Local Institution
  • Hawaii
    • Honolulu, Hawaii, United States
      • Local Institution
  • Kansas
    • Overland Park, Kansas, United States
      • Local Institution
    • Shawnee Mission, Kansas, United States
      • Local Institution
    • Wichita, Kansas, United States
      • Local Institution
  • Kentucky
    • Louisville, Kentucky, United States
      • Local Institution
    • Richmond, Kentucky, United States
      • Local Institution
  • Louisiana
    • SLidell, Louisiana, United States
      • Local Institution
  • Maryland
    • Chester, Maryland, United States
      • Local Institution
    • Silver Spring, Maryland, United States
      • Local Institution
  • Massachusetts
    • Ayer, Massachusetts, United States
      • Local Institution
    • Springfield, Massachusetts, United States
      • Local Institution
    • Sudbury, Massachusetts, United States
      • Local Institution
  • Michigan
    • Lansing, Michigan, United States
      • Local Institution
  • Minnesota
    • Arden Hills, Minnesota, United States
      • Local Institution
  • Mississippi
    • Gulfport, Mississippi, United States
      • Local Institution
    • Olive Branch, Mississippi, United States
      • Local Institution
    • Rolling Fork, Mississippi, United States
      • Local Institution
  • Missouri
    • Excelsior Springs, Missouri, United States
      • Local Institution
    • Kansas City, Missouri, United States
      • Local Institution
    • Springfield, Missouri, United States
      • Local Institution
    • St. Peters, Missouri, United States
      • Local Institution
    • St.Louis, Missouri, United States
      • Local Institution
  • Nebraska
    • Omaha, Nebraska, United States
      • Local Institution
  • New Jersey
    • Toms River, New Jersey, United States
      • Local Institution
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Local Institution
  • New York
    • 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
  • North Carolina
    • 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
  • Ohio
    • Cincinnati, Ohio, United States
      • Local Institution
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Local Institution
    • Tulsa, Oklahoma, United States
      • Local Institution
  • Oregon
    • Corvallis, Oregon, United States
      • Local Institution
    • Eugene, Oregon, United States
      • Local Institution
    • Hillsboro, Oregon, United States
      • Local Institution
    • Portland, Oregon, United States
      • Local Institution
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Local Institution
    • Warminster, Pennsylvania, United States
      • Local Institution
  • Rhode Island
    • Cranston, Rhode Island, United States
      • Local Institution
  • South Carolina
    • Duncan, South Carolina, United States
      • Local Institution
    • Greer, South Carolina, United States
      • Local Institution
    • Simpsonville, South Carolina, United States
      • Local Institution
  • Tennessee
    • Bristol, Tennessee, United States
      • Local Institution
    • Kingsport, Tennessee, United States
      • Local Institution
    • Memphis, Tennessee, United States
      • Local Institution
  • Texas
    • 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
  • Utah
    • Salt Lake City, Utah, United States
      • Local Institution
  • Virginia
    • Springfield, Virginia, United States
      • Local Institution
    • Virginia Beach, Virginia, United States
      • Local Institution
  • Washington
    • Olympia, Washington, United States
      • Local Institution
    • Renton, Washington, United States
      • Local Institution
    • Spokane, Washington, United States
      • Local Institution
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Study Completion (ACTUAL): May 1, 2004

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (ESTIMATE): September 13, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): April 27, 2012
• Last Update Submitted That Met QC Criteria: April 26, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Metabolics Diabetes New Onset
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CV168-022