PPAR-COMBO With Sulfonylurea

September 10, 2010 updated 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 Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

534

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
      • Cordoba, Argentina
        • Local Institution
      • Mendoza, Argentina
        • Local Institution
    • Buenas Aires
      • Bahia Blanca, Buenas Aires, Argentina
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina
        • Local Institution
  • Australia
    • New South Wales
      • Canberra, New South Wales, Australia
        • Local Institution
      • Wollongong, New South Wales, Australia
        • Local Institution
    • Queensland
      • Brisbane, Queensland, 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
    • Sao Paulo
      • Marilia, Sao Paulo, Brazil
        • Local Institution
  • Canada
      • St. John's, Canada
        • Local Institution
    • Ontario
      • Corunna, Ontario, Canada
        • Local Institution
      • Hawksbury, Ontario, Canada
        • Local Institution
      • Sarnia, Ontario, Canada
        • Local Institution
    • Quebec
      • Gatineau, Quebec, Canada
        • Local Institution
      • Laval, Quebec, Canada
        • Local Institution
      • St. Jerome, Quebec, Canada
        • Local Institution
  • France
      • Broglie, France
        • Local Institution
      • Chartres, France
        • Local Institution
      • Gemenos, France
        • Local Institution
    • D'Egletons
      • Rosiers, D'Egletons, France
        • Local Institution
    • Sur Leze
      • Labarthe, Sur Leze, France
        • Local Institution
    • Wesserling
      • Husseren, Wesserling, France
        • Local Institution
  • Germany
      • Dresden, Germany
        • Local Institution
      • Hamburg, Germany
        • Local Institution
      • Nuernberg, Germany
        • Local Institution
    • Schwenningen
      • Viernheim, Schwenningen, Germany
        • Local Institution
  • Italy
      • Ravenna, Italy
        • Local Institution
  • Mexico
      • 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
    • New Mexico
      • Albuquerque, New Mexico, Mexico
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico
        • Local Institution
  • Netherlands
      • Deurne, Netherlands
        • Local Institution
      • Ewyk, Netherlands
        • Local Institution
      • Hoogvliet, Netherlands
        • Local Institution
      • Rijswijk, Netherlands
        • Local Institution
      • S Gravenhage, Netherlands
        • Local Institution
      • Zwijndrecht, Netherlands
        • Local Institution
  • Peru
      • Arequipa, Peru
        • Local Institution
      • Lima, Peru
        • Local Institution
  • Puerto Rico
      • Carolina, Puerto Rico
        • Local Institution
      • Guaynabo, Puerto Rico
        • Local Institution
      • Ponce, Puerto Rico
        • Local Institution
      • Rio Piedras, Puerto Rico
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation
        • Local Institution
      • Saratov, Russian Federation
        • Local Institution
      • Smolensk, Russian Federation
        • Local Institution
      • St. Petersburg, Russian Federation
        • Local Institution
  • Spain
      • A Coruna, Spain
        • Local Institution
      • Alicante, Spain
        • Local Institution
      • Cadiz, Spain
        • Local Institution
      • Granada, Spain
        • Local Institution
      • La Coruna, Spain
        • Local Institution
      • Madrid, Spain
        • Local Institution
      • Oviedo, Spain
        • Local Institution
      • Tenerife, Spain
        • Local Institution
      • Teruel, Spain
        • Local Institution
      • Zaragoza, Spain
        • Local Institution
    • DE
      • Las Palmas, DE, Spain
        • Local Institution
    • de Compostela
      • Santiago, de Compostela, Spain
        • Local Institution
  • United Kingdom
      • Swan Lane, United Kingdom
        • Local Institution
    • Cambridgeshire
      • Soham, Cambridgeshire, United Kingdom
        • Local Institution
    • East Sussex
      • Bexhill-on-Sea, East Sussex, 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
    • Middlesex
      • Harrow, Middlesex, United Kingdom
        • Local Institution
    • Sussex
      • Hastings, Sussex, 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
      • Hoover, Alabama, United States
        • Local Institution
      • Huntsville, 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
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Encinitas, California, United States
        • Local Institution
      • Long Beach, California, United States
        • Local Institution
      • Los Angeles, California, United States
        • Local Institution
      • Mission Viejo, California, United States
        • Local Institution
      • Pasadena, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • Walnut Creek, California, United States
        • Local Institution
      • Westlake Village, California, United States
        • Local Institution
    • Colorado
      • Colorado Springs, Colorado, United States
        • Local Institution
      • Denver, Colorado, United States
        • Local Institution
      • Loveland, Colorado, United States
        • Local Institution
      • Wheat Ridge, Colorado, United States
        • Local Institution
    • Florida
      • Chipley, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
      • New Port Richey, Florida, United States
        • Local Institution
      • Pinellas Park, Florida, United States
        • Local Institution
      • Vero Beach, Florida, United States
        • Local Institution
      • Winter Park, Florida, United States
        • Local Institution
    • Georgia
      • Dunwoody, Georgia, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
    • Kansas
      • Overland Park, Kansas, United States
        • Local Institution
    • Kentucky
      • Lexington, Kentucky, United States
        • Local Institution
    • Louisiana
      • Slidell, Louisiana, United States
        • Local Institution
    • Maryland
      • Chester, Maryland, United States
        • Local Institution
      • Silver Springs, Maryland, United States
        • Local Institution
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Local Institution
    • Michigan
      • Berkley, Michigan, United States
        • Local Institution
      • Detroit, Michigan, United States
        • Local Institution
    • Minnesota
      • Arden Hills, Minnesota, United States
        • Local Institution
    • Mississippi
      • Gulfport, Mississippi, United States
        • Local Institution
    • Missouri
      • Excelsior Springs, Missouri, United States
        • Local Institution
      • Kansas City, Missouri, United States
        • Local Institution
      • St. Louis, Missouri, United States
        • Local Institution
    • New York
      • East Syracuse, New York, United States
        • Local Institution
    • North Carolina
      • Charlotte, North Carolina, United States
        • Local Institution
      • Greensboro, North Carolina, United States
        • Local Institution
      • Hickory, North Carolina, United States
        • Local Institution
      • Huntersville, North Carolina, United States
        • Local Institution
      • Morehead City, North Carolina, United States
        • Local Institution
      • Wilmington, 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
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • Local Institution
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • Rhode Island
      • Cranston, Rhode Island, United States
        • Local Institution
    • South Carolina
      • Anderson, South Carolina, United States
        • Local Institution
      • Duncan, South Carolina, United States
        • Local Institution
      • Simpsonville, South Carolina, United States
        • Local Institution
      • Summerville, South Carolina, United States
        • Local Institution
    • Tennessee
      • Bristol, Tennessee, United States
        • Local Institution
      • Kingsport, Tennessee, United States
        • Local Institution
      • Knoxville, 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
      • San Antonio, Texas, United States
        • Local Institution
      • The Colony, Texas, United States
        • Local Institution
    • Washington
      • Olympia, Washington, United States
        • Local Institution
    • West Virginia
      • Bluefield, West Virginia, United States
        • Local Institution
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 . 1.5 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide

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

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

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)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV168-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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