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

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

Study Overview

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

• Study Type: Interventional
• Enrollment: 1260
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Local Institution
  • Mendoza, Argentina
    • Local Institution
  • Buenos Aires
    • Chacabuco, Buenos Aires, Argentina
      • Local Institution
• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia
      • Local Institution
  • South Australia
    • Fullerton, South Australia, Australia
      • Local Institution
  • Victoria
    • Box Hill, Victoria, Australia
      • Local Institution
    • Fitzroy, Victoria, Australia
      • Local Institution
    • Melbourne, Victoria, Australia
      • Local Institution
    • Parkville, Victoria, Australia
      • Local Institution
  • Western Australia
    • Perth, Western Australia, Australia
      • Local Institution
• Brazil
  • Rio de Janeiro, Brazil
    • Local Institution
  • Sao Paulo, Brazil
    • Local Institution
  • Ceara
    • Fortaleza, Ceara, Brazil
      • Local Institution
  • Mato Grosso
    • Campo Grande, Mato Grosso, Brazil
      • Local Institution
  • Para
    • Belem, Para, Brazil
      • Local Institution
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Local Institution
  • SAO Paulo
    • Campinas, SAO Paulo, Brazil
      • Local Institution
  • Sao Paulo
    • Marilia, Sao Paulo, Brazil
      • Local Institution
    • S. J. Rio Preto, Sao Paulo, Brazil
      • Local Institution
    • Taubate, Sao Paulo, Brazil
      • Local Institution
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Local Institution
    • Edmonton, Alberta, Canada
      • Local Institution
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Local Institution
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
      • Local Institution
  • Ontario
    • Ottawa, Ontario, Canada
      • Local Institution
  • Quebec
    • Drummonville, Quebec, Canada
      • Local Institution
    • Longueuil, Quebec, Canada
      • Local Institution
    • Ottawa, Quebec, Canada
      • Local Institution
    • Sherbrooke, Quebec, Canada
      • Local Institution
• Czech Republic
  • Ceske Budejovice, Czech Republic
    • Local Institution
  • Jihlava, Czech Republic
    • Local Institution
  • Liberec, Czech Republic
    • Local Institution
  • Prague, Czech Republic
    • Local Institution
  • CZE
    • Brno, CZE, Czech Republic
      • Local Institution
• France
  • Albens, France
    • Local Institution
  • Orthez, France
    • Local Institution
  • Rennes, France
    • Local Institution
  • Rosiers D'Egletons, France
    • Local Institution
  • Savigny en Veron, France
    • Local Institution
  • Strasbourg, France
    • Local Institution
• Italy
  • Milano, Italy
    • Local Institution
  • Modena, Italy
    • Local Institution
  • Roma, Italy
    • Local Institution
• Mexico
  • Aguascalientes, Mexico
    • Local Institution
  • Distrito Federal, Mexico
    • Local Institution
  • Baja California
    • Tijuana, Baja California, Mexico
      • Local Institution
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico
      • Local Institution
• Netherlands
  • Deventer, Netherlands
    • Local Institution
  • Ewijk, Netherlands
    • Local Institution
  • Hengelo, Netherlands
    • Local Institution
  • Lichtenvoorde, Netherlands
    • Local Institution
  • Losser, Netherlands
    • Local Institution
  • Ryswyk, Netherlands
    • Local Institution
  • Utrecht, Netherlands
    • Local Institution
• Poland
  • Bydgoszcz, Poland
    • Local Institution
  • Lublin, Poland
    • Local Institution
  • Olsztyn, Poland
    • Local Institution
  • Szczecin, Poland
    • Local Institution
  • Warszawa, Poland
    • Local Institution
  • Wroclaw, Poland
    • Local Institution
  • Zabrze, Poland
    • Local Institution
  • Zielona Gora, Poland
    • Local Institution
  • Wielkopolski
    • Gorzow, Wielkopolski, Poland
      • Local Institution
  • Wola
    • Stalowa, Wola, Poland
      • Local Institution
• Puerto Rico
  • Ponce, Puerto Rico
    • Local Institution
  • San Juan, Puerto Rico
    • Local Institution
• South Africa
  • Gauteng
    • Noordheuwel, Gauteng, South Africa
      • Local Institution
    • Pretoria, Gauteng, South Africa
      • Local Institution
    • Vanderbijlpark, Gauteng, South Africa
      • Local Institution
  • Northern Cape
    • George, Northern Cape, South Africa
      • Local Institution
  • Western Cape
    • Tygerberg, Western Cape, South Africa
      • Local Institution
• Spain
  • Girona, Spain
    • Local Institution
  • Granada, Spain
    • Local Institution
  • Las Palmas de G.C., Spain
    • Local Institution
  • Madrid, Spain
    • Local Institution
  • Oviedo, Spain
    • Local Institution
  • De Compostela
    • Santiago, De Compostela, Spain
      • Local Institution
  • ESP
    • Barcelona, ESP, Spain
      • Local Institution
    • Cadiz, ESP, Spain
      • Local Institution
  • Queensland
    • Herston, Queensland, Spain
      • Local Institution
• Sweden
  • Gothenburg, Sweden
    • Local Institution
  • Helsingborg, Sweden
    • Local Institution
  • Linkoping, Sweden
    • Local Institution
  • Malmo, Sweden
    • Local Institution
  • Motala, Sweden
    • Local Institution
  • Savedalen, Sweden
    • Local Institution
  • Stockholm, Sweden
    • Local Institution
  • Vallingby, Sweden
    • Local Institution
• United Kingdom
  • Glasgow, United Kingdom
    • Local Institution
  • Armach
    • Newtonabbey, Armach, United Kingdom
      • Local Institution
  • Cambridgeshire
    • Ely, Cambridgeshire, United Kingdom
      • Local Institution
    • Soham, Cambridgeshire, United Kingdom
      • Local Institution
  • Central
    • Blantyre, Central, United Kingdom
      • Local Institution
    • Chapelhall, Central, United Kingdom
      • Local Institution
    • Paisley, Central, United Kingdom
      • Local Institution
    • Riddrie, Central, United Kingdom
      • Local Institution
  • Dumbartonshire
    • Cumbernauld, Dumbartonshire, United Kingdom
      • Local Institution
    • Moodiesburn, Dumbartonshire, United Kingdom
      • Local Institution
  • Dumfries & Galloway
    • Annan, Dumfries & Galloway, United Kingdom
      • Local Institution
    • Dunscore, Dumfries & Galloway, United Kingdom
      • Local Institution
    • Stranraer, Dumfries & Galloway, United Kingdom
      • Local Institution
  • Dumfriesshire
    • Moffat, Dumfriesshire, 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
  • Gwent
    • Caerleon, Gwent, United Kingdom
      • Local Institution
  • Lanarkshire
    • Burnbank, Lanarkshire, United Kingdom
      • Local Institution
    • Coatbridge, Lanarkshire, United Kingdom
      • Local Institution
  • Lothian
    • Edinburgh, Lothian, United Kingdom
      • Local Institution
    • Hamilton, Lothian, United Kingdom
      • Local Institution
  • Mid Glamorgan
    • Llandough, Mid Glamorgan, United Kingdom
      • Local Institution
    • Pontyclun, Mid Glamorgan, United Kingdom
      • Local Institution
  • Renfrewshire
    • Neilston, Renfrewshire, United Kingdom
      • Local Institution
    • Paisley, Renfrewshire, United Kingdom
      • Local Institution
  • Stirlingshire
    • Kilsyth, Stirlingshire, United Kingdom
      • Local Institution
  • Strathclyde
    • Lanarkshire, Strathclyde, United Kingdom
      • Local Institution
  • Surrey
    • East Horsley, Surrey, United Kingdom
      • Local Institution
  • Tyrone
    • Cookstown, Tyrone, United Kingdom
      • Local Institution
  • Warwickshire
    • Atherstone, Warwickshire, United Kingdom
      • Local Institution
    • Balsall Common, Warwickshire, United Kingdom
      • Local Institution
    • Stratford Upon Avon, Warwickshire, United Kingdom
      • Local Institution
  • West Midlands
    • Chelmsley wod, West Midlands, United Kingdom
      • Local Institution
  • Wiltshire
    • Chippenham, Wiltshire, United Kingdom
      • Local Institution
• United States
  • Alabama
    • Anniston, Alabama, United States
      • Local Institution
    • Birmingham, Alabama, United States
      • Local Institution
    • Huntsville, Alabama, United States
      • Local Institution
  • Arizona
    • Hot Springs, Arizona, United States
      • Local Institution
    • Mesa, Arizona, United States
      • Local Institution
    • Phoenix, Arizona, United States
      • Local Institution
    • Tempe, 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
    • Bakersfield, California, United States
      • Local Institution
    • Concord, California, United States
      • Local Institution
    • Encinitas, California, United States
      • Local Institution
    • Fair Oaks, California, United States
      • Local Institution
    • Fountain Valley, California, United States
      • Local Institution
    • Fresno, California, United States
      • Local Institution
    • La Jolla, California, United States
      • Local Institution
    • Los Gatos, California, United States
      • Local Institution
    • Orange, California, United States
      • Local Institution
    • Raleigh, California, United States
      • Local Institution
    • Riverside, California, United States
      • Local Institution
    • Rolling Hills Estate, California, United States
      • Local Institution
    • Roseville, California, United States
      • Local Institution
    • Sacramento, California, United States
      • Local Institution
    • San Diego, California, United States
      • Local Institution
    • Santa Ana, California, United States
      • Local Institution
    • Santa Barbara, California, United States
      • Local Institution
    • Spring Valley, California, United States
      • Local Institution
    • Tustin, California, United States
      • Local Institution
    • Walnut Creek, California, United States
      • Local Institution
  • Colorado
    • Colorado Springs, Colorado, United States
      • Local Institution
    • Golden, Colorado, United States
      • Local Institution
    • Littleton, Colorado, United States
      • Local Institution
    • Nederland, Colorado, United States
      • Local Institution
    • Wheat Ridge, Colorado, United States
      • Local Institution
  • Connecticut
    • New Britain, Connecticut, United States
      • Local Institution
  • Florida
    • Brandon, Florida, United States
      • Local Institution
    • Chipley, Florida, United States
      • Local Institution
    • Coral Gables, Florida, United States
      • Local Institution
    • Daytona Beach, Florida, United States
      • Local Institution
    • Ft. Lauderdale, Florida, United States
      • Local Institution
    • Hollywood, Florida, United States
      • Local Institution
    • Jacksonville, Florida, United States
      • Local Institution
    • Jupiter, Florida, United States
      • Local Institution
    • Melbourne, Florida, United States
      • Local Institution
    • Miami, Florida, United States
      • Local Institution
    • Ocala, Florida, United States
      • Local Institution
    • Ocoee, Florida, United States
      • Local Institution
    • Orlando, Florida, United States
      • Local Institution
    • Pensacola, Florida, United States
      • Local Institution
    • St. Petersburg, Florida, United States
      • Local Institution
    • Tallahassee, Florida, United States
      • Local Institution
    • Tamarac, Florida, United States
      • Local Institution
    • Titusville, Florida, United States
      • Local Institution
    • West Palm Beach, Florida, United States
      • Local Institution
  • Georgia
    • Atlanta, Georgia, United States
      • Local Institution
    • Dunwoody, Georgia, United States
      • Local Institution
  • Hawaii
    • Honolulu, Hawaii, United States
      • Local Institution
  • Illinois
    • Chicago, Illinois, United States
      • Local Institution
    • Vernon Hills, Illinois, United States
      • Local Institution
  • Kansas
    • Arkansas City, Kansas, United States
      • Local Institution
    • Shawnee Mission, Kansas, United States
      • Local Institution
    • Wichita, Kansas, United States
      • Local Institution
  • Kentucky
    • Bardstown, Kentucky, United States
      • Local Institution
    • Lexington, Kentucky, United States
      • Local Institution
    • Louisville, Kentucky, United States
      • Local Institution
    • Richmond, Kentucky, United States
      • Local Institution
  • Louisiana
    • Metairie, Louisiana, United States
      • Local Institution
    • Slidell, Louisiana, United States
      • Local Institution
  • Maine
    • Bangor, Maine, United States
      • Local Institution
  • Maryland
    • Baltimore, Maryland, United States
      • Local Institution
    • Chevy Chase, Maryland, United States
      • Local Institution
  • Massachusetts
    • Norwood, Massachusetts, United States
      • Local Institution
    • Springfield, Massachusetts, United States
      • Local Institution
    • Swansea, Massachusetts, United States
      • Local Institution
    • Worcester, Massachusetts, United States
      • Local Institution
  • Michigan
    • Birmingham, Michigan, United States
      • Local Institution
    • Petoskey, Michigan, United States
      • Local Institution
  • Minnesota
    • Arden Hills, Minnesota, United States
      • Local Institution
  • Mississippi
    • Bay Saint Louis, Mississippi, United States
      • Local Institution
    • Cleveland, Mississippi, United States
      • Local Institution
    • Jackson, 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. Louis, Missouri, United States
      • Local Institution
  • Nebraska
    • Omaha, Nebraska, United States
      • Local Institution
  • Nevada
    • Las Vegas, Nevada, 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
    • Camillus, New York, United States
      • Local Institution
    • Endicott, New York, United States
      • Local Institution
    • Johnson City, New York, United States
      • Local Institution
    • New Hyde Park, New York, United States
      • Local Institution
    • New York, New York, United States
      • Local Institution
  • North Carolina
    • Cary, North Carolina, United States
      • Local Institution
    • Charlotte, North Carolina, United States
      • Local Institution
    • Greensboro, North Carolina, United States
      • Local Institution
    • High Point, North Carolina, United States
      • Local Institution
    • Moorehead City, North Carolina, United States
      • Local Institution
    • Raleigh, North Carolina, United States
      • Local Institution
  • Ohio
    • Avon, Ohio, United States
      • Local Institution
    • Beavercreek, Ohio, United States
      • Local Institution
    • Bellbrook, Ohio, United States
      • Local Institution
    • Canton, Ohio, United States
      • Local Institution
    • Cincinnati, Ohio, United States
      • Local Institution
    • Cleveland, Ohio, United States
      • Local Institution
    • Colombus, Ohio, United States
      • Local Institution
    • Lyndhurst, Ohio, United States
      • Local Institution
    • Massillon, Ohio, United States
      • Local Institution
    • Zanesville, Ohio, United States
      • Local Institution
  • Oklahoma
    • Tulsa, Oklahoma, United States
      • Local Institution
  • Oregon
    • Eugene, Oregon, United States
      • Local Institution
    • Medford, Oregon, United States
      • Local Institution
    • Portland, Oregon, United States
      • Local Institution
  • Pennsylvania
    • Reading, Pennsylvania, United States
      • Local Institution
  • Rhode Island
    • Cranston, Rhode Island, United States
      • Local Institution
    • E. Providence, Rhode Island, United States
      • Local Institution
    • Johnston, Rhode Island, United States
      • Local Institution
    • Providence, Rhode Island, United States
      • Local Institution
  • South Carolina
    • Anderson, South Carolina, United States
      • Local Institution
    • Charleston, South Carolina, United States
      • Local Institution
    • Greer, South Carolina, United States
      • Local Institution
    • Simpsonville, South Carolina, United States
      • Local Institution
    • Spartanburg, South Carolina, United States
      • Local Institution
  • Tennessee
    • Bristol, Tennessee, United States
      • Local Institution
    • Johnson City, Tennessee, United States
      • Local Institution
    • Memphis, Tennessee, United States
      • Local Institution
  • Texas
    • Austin, Texas, United States
      • Local Institution
    • Corpus Christi, Texas, United States
      • Local Institution
    • Dallas, Texas, United States
      • Local Institution
    • Ft. Worth, Texas, United States
      • Local Institution
    • Houston, Texas, United States
      • Local Institution
    • Irving, Texas, United States
      • Local Institution
    • Lake Jackson, Texas, United States
      • Local Institution
    • San Antonio, Texas, United States
      • Local Institution
  • Utah
    • Salt Lake City, Utah, United States
      • Local Institution
  • Virginia
    • Richmond, Virginia, United States
      • Local Institution
    • Virginia Beach, Virginia, United States
      • Local Institution
  • Washington
    • Edmonds, Washington, United States
      • Local Institution
    • Federal Way, Washington, United States
      • Local Institution
    • Renton, Washington, United States
      • Local Institution
    • Spokane, Washington, United States
      • Local Institution
    • Walla Walla, Washington, United States
      • Local Institution
  • Wisconsin
    • Madison, Wisconsin, United States
      • Local Institution
    • New Berlin, 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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: October 17, 2005
• First Submitted That Met QC Criteria: October 17, 2005
• First Posted (Estimate): October 18, 2005

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 10, 2010
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: CV168-006