A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics

September 10, 2010 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Double-Blind, Active-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Compared to Pioglitazone in Combination With Metformin in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone

The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1159

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

  • Canada
    • Alberta
      • Red Deer, Alberta, Canada
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Local Institution
    • Ontario
      • Sarnia, Ontario, Canada
        • Local Institution
    • Quebec
      • Bonaventure, Quebec, Canada
        • Local Institution
      • Drummondville, Quebec, Canada
        • Local Institution
      • Montreal, Quebec, Canada
        • Local Institution
      • Rimouski, Quebec, Canada
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico
        • Local Institution
      • Chihuahua, Mexico
        • Local Institution
    • Baja California
      • Tijuana, Baja California, Mexico
        • Local Institution
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico
        • Local Institution
    • Durango
      • Mexico, Durango, Mexico
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Local Institution
  • Puerto Rico
      • Aguas Buenas, Puerto Rico
        • Local Institution
      • Ponce, Puerto Rico
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Local Institution
      • Columbiana, Alabama, United States
        • Local Institution
    • Arizona
      • Mesa, Arizona, United States
        • Local Institution
      • Peoria, Arizona, United States
        • Local Institution
    • Arkansas
      • Carlisle, Arkansas, United States
        • Local Institution
      • Jonesboro, Arkansas, United States
        • Local Institution
      • Little Rock, Arkansas, United States
        • Local Institution
      • Pine Bluff, Arkansas, United States
        • Local Institution
      • Sherwood, Arkansas, United States
        • Local Institution
    • California
      • Anaheim, California, United States
        • Local Institution
      • Artesia, California, United States
        • Local Institution
      • Encino, California, United States
        • Local Institution
      • Encintas, California, United States
        • Local Institution
      • Fresno, California, United States
        • Local Institution
      • Long Beach, California, United States
        • Local Institution
      • Los Angeles, California, United States
        • Local Institution
      • Northridge, California, United States
        • Local Institution
    • Colorado
      • Denver, Colorado, United States
        • Local Institution
    • Connecticut
      • Hamden, Connecticut, United States
        • Local Institution
    • Florida
      • Altamonte Springs, Florida, United States
        • Local Institution
      • Hollywood, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
      • New Port Richie, Florida, United States
        • Local Institution
      • St. Cloud, Florida, United States
        • Local Institution
      • W Palm Beach, Florida, United States
        • Local Institution
    • Hawaii
      • Honolulu, Hawaii, United States
        • Local Institution
    • Indiana
      • Evansville, Indiana, United States
        • Local Institution
      • Lafayette, Indiana, United States
        • Local Institution
    • Louisiana
      • New Orleans, Louisiana, United States
        • Local Institution
      • Shreveport, Louisiana, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Michigan
      • Detroit, Michigan, United States
        • Local Institution
    • Mississippi
      • Gulfport, Mississippi, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • Nebraska
      • Omaha, Nebraska, United States
        • Local Institution
    • New York
      • Endwell, New York, United States
        • Local Institution
    • North Carolina
      • Cary, North Carolina, United States
        • Local Institution
      • Charlotte, North Carolina, United States
        • Local Institution
      • Morehead, North Carolina, United States
        • Local Institution
      • Raleigh, North Carolina, United States
        • Local Institution
      • Statesville, North Carolina, United States
        • Local Institution
      • Wilmington, North Carolina, United States
        • Local Institution
      • Winston-Salem, North Carolina, United States
        • Local Institution
    • Ohio
      • Bellbrook, Ohio, United States
        • Local Institution
      • Maumee, Ohio, United States
        • Local Institution
      • Thornville, Ohio, United States
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States
        • Local Institution
      • Melrose Park, Pennsylvania, United States
        • Local Institution
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
      • West Chester, Pennsylvania, United States
        • Local Institution
      • Youngwood, Pennsylvania, United States
        • Local Institution
    • Rhode Island
      • East Providence, Rhode Island, United States
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States
        • Local Institution
      • Clinton, South Carolina, United States
        • Local Institution
    • Tennessee
      • Memphis, Tennessee, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Carrollton, Texas, United States
        • Local Institution
      • Corpus Christi, Texas, United States
        • Local Institution
      • Dallas, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
      • Midland, Texas, United States
        • Local Institution
      • San Antonio, Texas, United States
        • Local Institution
    • Utah
      • Salt Lake City, Utah, United States
        • Local Institution
    • Virginia
      • Lebanon, Virginia, United States
        • Local Institution
    • Washington
      • Spokane, Washington, United States
        • Local Institution
      • Tacoma, Washington, United States
        • Local Institution
    • West Virginia
      • Bluefield, West Virginia, 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 diabetics
  • HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study.
  • Fasting C-peptide ≥1.0 ng/mL
  • BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL

Exclusion Criteria:

  • symptomatic type 2 diabetics with > 10% weight loss 3 months prior to study
  • history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling
  • 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 of, 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 basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + 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

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

Sponsor

Bristol-Myers Squibb

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

October 1, 2003

Primary Completion (Actual)

March 1, 2005

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

  • CV168-025

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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