PPAR-COMBO With Sulfonylurea

NCT ID: NCT00162175

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-11-30

Brief Summary

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A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.

Detailed Description

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Conditions

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Metabolics Diabetes Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Muraglitazar

Intervention Type DRUG

Eligibility Criteria

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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 . 1.5 ng/mL.

Exclusion Criteria

* History of MI (myocardial infarction), 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 or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Anniston, Alabama, United States

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Hoover, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Encinitas, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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Walnut Creek, California, United States

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Westlake Village, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Loveland, Colorado, United States

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Wheat Ridge, Colorado, United States

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Chipley, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Pinellas Park, Florida, United States

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Vero Beach, Florida, United States

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Winter Park, Florida, United States

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Dunwoody, Georgia, United States

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Chicago, Illinois, United States

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Overland Park, Kansas, United States

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Lexington, Kentucky, United States

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Slidell, Louisiana, United States

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Chester, Maryland, United States

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Silver Springs, Maryland, United States

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Springfield, Massachusetts, United States

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Berkley, Michigan, United States

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Detroit, Michigan, United States

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Arden Hills, Minnesota, United States

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Gulfport, 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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St Louis, Missouri, United States

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East Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Huntersville, North Carolina, United States

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Morehead City, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Corvallis, Oregon, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Anderson, South Carolina, United States

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Duncan, South Carolina, United States

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Simpsonville, South Carolina, United States

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Summerville, South Carolina, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, 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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The Colony, Texas, United States

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Olympia, Washington, United States

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Bluefield, West Virginia, United States

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Marshfield, Wisconsin, United States

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Bahía Blanca, Buenas Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Canberra, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Brisbane, Queensland, Australia

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Curitiba, Paraná, Brazil

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Belém, Pará, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Marília, São Paulo, Brazil

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Corunna, Ontario, Canada

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Hawksbury, Ontario, Canada

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Sarnia, Ontario, Canada

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Gatineau, Quebec, Canada

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Laval, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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St. John's, , Canada

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Rosiers, D'Egletons, France

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Labarthe, Sur Leze, France

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Husseren-Wesserling, Wesserling, France

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Broglie, , France

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Chartres, , France

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Gémenos, , France

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Viernheim, Schwenningen, Germany

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Dresden, , Germany

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Hamburg, , Germany

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Nuremberg, , Germany

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Ravenna, , Italy

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Durango, Durango, Mexico

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Tijuana, Estado de Baja California, Mexico

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León, Guanajuato, Mexico

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Mexico City, Mexico City, Mexico

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Alburquerque, New Mexico, Mexico

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Monterrey, Nuevo León, Mexico

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Mérida, Yucatán, Mexico

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Deurne, , Netherlands

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Ewyk, , Netherlands

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Hoogvliet, , Netherlands

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Rijswijk, , Netherlands

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The Hague, , Netherlands

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Zwijndrecht, , Netherlands

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Arequipa, Arequipa, Peru

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Lima, Lima Province, Peru

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Carolina, , Puerto Rico

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Guaynabo, , Puerto Rico

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Ponce, , Puerto Rico

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Rio Piedras, , Puerto Rico

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Santiago, De Compostela, Spain

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Las Palmas, DE, Spain

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A Coruña, , Spain

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Alicante, , Spain

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Cadiz, , Spain

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Granada, , Spain

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Madrid, , Spain

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Oviedo, , Spain

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Santa Cruz de Tenerife, , Spain

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Teruel, , Spain

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Zaragoza, , Spain

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Soham, Cambridgeshire, United Kingdom

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Bexhill-on-Sea, East Sussex, United Kingdom

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Sunbury-on-Thames, Greater London, United Kingdom

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Aldershot, Hampshire, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Harrow, Middlesex, United Kingdom

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Hastings, Sussex, United Kingdom

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Bath, Wiltshire, United Kingdom

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Inkberrow, Worcestershire, United Kingdom

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Swan Lane, , United Kingdom

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Countries

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United States Argentina Australia Brazil Canada France Germany Italy Mexico Netherlands Peru Puerto Rico Russia Spain United Kingdom

References

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Rubin CJ, De Pril V, Fiedorek FT. Coadministration of muraglitazar plus glyburide: improvement of glycaemic and lipid profiles in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Apr;6(2):120-32. doi: 10.1177/1479164109336049.

Reference Type DERIVED
PMID: 20368202 (View on PubMed)

Other Identifiers

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CV168-021

Identifier Type: -

Identifier Source: org_study_id