Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone

September 10, 2010 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Subjects Wtih Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Drug: muraglitazar

Study Type

Interventional

Enrollment

1752

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
- Buenos Aires
  - Capital Federal, Buenos Aires, Argentina
    - Local Institution
  - Chacabuco, Buenos Aires, Argentina
    - Local Institution
  - El Palomar, Buenos Aires, Argentina
    - Local Institution
  - Mar Del Plata, Buenos Aires, Argentina
    - Local Institution
  - San Martin, Buenos Aires, Argentina
    - Local Institution
Austria
- - Graz, Austria
    - Local Institution
  - Salzburg, Austria
    - Local Institution
  - Wien, Austria
    - Local Institution
Brazil
- - Rio De Janeiro, Brazil
    - Local Institution
  - Sao Paulo, Brazil
    - Local Institution
- Ceara
  - Fortaleza, Ceara, Brazil
    - Local Institution
- Distrito Federal
  - Brasilia, Distrito Federal, Brazil
    - Local Institution
- Parana
  - Curitiba, Parana, Brazil
    - Local Institution
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil
    - Local Institution
- Sao Paulo
  - Campinas, Sao Paulo, Brazil
    - Local Institution
  - Marilia, Sao Paulo, Brazil
    - Local Institution
Canada
- - Quebec, Canada
    - Local Institution
- Alberta
  - Calgary, Alberta, Canada
    - Local Institution
  - Red Deer, Alberta, Canada
    - Local Institution
- British Columbia
  - Delta, British Columbia, Canada
    - Local Institution
  - Kelowna, British Columbia, Canada
    - Local Institution
  - North Vancouver, British Columbia, Canada
    - Local Institution
  - Vancouver, British Columbia, Canada
    - Local Institution
- Manitoba
  - Winnipeg, Manitoba, Canada
    - Local Institution
- Newfoundland and Labrador
  - Mount Pearl, Newfoundland and Labrador, Canada
    - Local Institution
  - St. John, Newfoundland and Labrador, Canada
    - Local Institution
- Ontario
  - London, Ontario, Canada
    - Local Institution
  - North York, Ontario, Canada
    - Local Institution
  - Oshawa, Ontario, Canada
    - Local Institution
  - Peterborough, Ontario, Canada
    - Local Institution
  - Sarnia, Ontario, Canada
    - Local Institution
  - Toronto, Ontario, Canada
    - Local Institution
  - Woodstock, Ontario, Canada
    - Local Institution
  - York, Ontario, Canada
    - Local Institution
- Prince Edward Island
  - Charlottetown, Prince Edward Island, Canada
    - Local Institution
- Quebec
  - Chicoutimi, Quebec, Canada
    - Local Institution
  - Drummondville, Quebec, Canada
    - Local Institution
  - Fleurimont, Quebec, Canada
    - Local Institution
  - Granby, Quebec, Canada
    - Local Institution
  - Greenfield Park, Quebec, Canada
    - Local Institution
  - Longueuil, Quebec, Canada
    - Local Institution
  - Saint-Lambert, Quebec, Canada
    - Local Institution
  - Ste-Foy, Quebec, Canada
    - Local Institution
  - mONTREAL, Quebec, Canada
    - Local Institution
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada
    - Local Institution
Chile
- Metropolitana
  - Santiago, Metropolitana, Chile
    - Local Institution
Germany
- - Kuenzing, Germany
    - Local Institution
  - Magdeburg, Germany
    - Local Institution
  - Muenchen, Germany
    - Local Institution
  - Nuernberg, Germany
    - Local Institution
  - Rodgau, Germany
    - Local Institution
  - Rotenburg / Fulda, Germany
    - Local Institution
  - Schoenebeck, Germany
    - Local Institution
  - Ulm, Germany
    - Local Institution
  - Viernheim, Germany
    - Local Institution
  - Vs-Schwenningen, Germany
    - Local Institution
  - Witten, Germany
    - Local Institution
Hong Kong
- - Chai Wan, Hong Kong
    - Local Institution
  - Hong Kong, Hong Kong
    - Local Institution
  - Shatin, Hong Kong
    - Local Institution
Mexico
- - Chihuahua, Mexico
    - Local Institution
  - Durango, Mexico
    - Local Institution
- Baja California
  - Tijuana, Baja California, Mexico
    - Local Institution
- Distrito Federal
  - Mexico, Distrito Federal, Mexico
    - Local Institution
- Jalisco
  - Guadalajara, Jalisco, 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
Philippines
- - Cavite, Philippines
    - Local Institution
  - Cebu, Philippines
    - Local Institution
  - Manila, Philippines
    - Local Institution
  - Pasig City, Philippines
    - Local Institution
  - Quezon, Philippines
    - Local Institution
Poland
- - Gorzow Wielkopolski, Poland
    - Local Institution
  - Krakow, Poland
    - Local Institution
  - Mrokow, Poland
    - Local Institution
  - Stalowa Wola, Poland
    - Local Institution
  - Warszawa, Poland
    - Local Institution
  - Wroclaw, Poland
    - Local Institution
  - Zabrze, Poland
    - Local Institution
Puerto Rico
- - Carolina, Puerto Rico
    - Local Institution
  - Ponce, Puerto Rico
    - Local Institution
  - Rio Piedras, Puerto Rico
    - Local Institution
  - San Juan, Puerto Rico
    - Local Institution
Russian Federation
- - Moscow, Russian Federation
    - Local Institution
  - Smolensk, Russian Federation
    - Local Institution
  - St. Petersburg, Russian Federation
    - Local Institution
Switzerland
- - Baden, Switzerland
    - Local Institution
Taiwan
- - Changhua, Taiwan
    - Local Institution
  - Hualien, Taiwan
    - Local Institution
  - Taichung, Taiwan
    - Local Institution
  - Tainan, Taiwan
    - Local Institution
Thailand
- - Bangkok, Thailand
    - Local Institution
United States
- Alabama
  - bIRMINGHAM, Alabama, United States
    - Local Institution
- Arizona
  - Mesa, Arizona, United States
    - Local Institution
  - Tucson, Arizona, United States
    - Local Institution
  - pHOENIX, Arizona, United States
    - Local Institution
- Arkansas
  - Fayetteville, Arkansas, United States
    - Local Institution
  - Jonesboro, Arkansas, United States
    - Local Institution
  - Little Rock, Arkansas, United States
    - Local Institution
  - Sherwood, Arkansas, United States
    - Local Institution
- California
  - Artesia, California, United States
    - Local Institution
  - Bellflower, California, United States
    - Local Institution
  - Cudahy, California, United States
    - Local Institution
  - Encino, California, United States
    - Local Institution
  - Fresno, California, United States
    - Local Institution
  - Huntington Beach, California, United States
    - Local Institution
  - Long Beach, California, United States
    - Local Institution
  - Mission Viejo, California, United States
    - Local Institution
  - Moreno Valley, California, United States
    - Local Institution
  - Paramount, California, United States
    - Local Institution
  - Pasadena, California, United States
    - Local Institution
  - Roseville, California, United States
    - Local Institution
  - Spring Valley, California, United States
    - Local Institution
  - Torrance, California, United States
    - Local Institution
  - Walnut Creek, California, United States
    - Local Institution
  - nORTHRIDGE, California, United States
    - Local Institution
- Colorado
  - Aurora, Colorado, United States
    - Local Institution
  - Colorado Springs, Colorado, United States
    - Local Institution
  - Denver, Colorado, United States
    - Local Institution
- Florida
  - Altamonte Springs, Florida, United States
    - Local Institution
  - Clearwater, Florida, United States
    - Local Institution
  - Deland, Florida, United States
    - Local Institution
  - Fort Lauderdale, Florida, United States
    - Local Institution
  - Kissimmee, Florida, United States
    - Local Institution
  - Longwood, 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
  - Ormond Beach, Florida, United States
    - Local Institution
  - Palm Harbor, Florida, United States
    - Local Institution
  - St Augustine, Florida, United States
    - Local Institution
  - St Cloud, Florida, United States
    - Local Institution
  - Tallahassee, Florida, United States
    - Local Institution
  - Winter Park, Florida, United States
    - Local Institution
  - hOLLYWOOD, Florida, United States
    - Local Institution
  - jACKSONVILLE, Florida, United States
    - Local Institution
  - pEMBROKE pINES, Florida, United States
    - Local Institution
- Georgia
  - Blue Ridge, Georgia, United States
    - Local Institution
- Illinois
  - Chicago, Illinois, United States
    - Local Institution
  - Chicago Heights, Illinois, United States
    - Local Institution
- Indiana
  - Elkhart, Indiana, United States
    - Local Institution
- Louisiana
  - Slidell, Louisiana, United States
    - Local Institution
- Maryland
  - Towson, Maryland, United States
    - Local Institution
  - bALTIMORE, Maryland, United States
    - Local Institution
- Massachusetts
  - Swansea, Massachusetts, United States
    - Local Institution
- Mississippi
  - Rolling Fork, Mississippi, United States
    - Local Institution
- Missouri
  - Chesterfield, Missouri, United States
    - Local Institution
  - Excelsior Springs, Missouri, United States
    - Local Institution
  - Florissant, 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
- New Jersey
  - Toms River, New Jersey, United States
    - Local Institution
- New Mexico
  - Albuquerque, New Mexico, United States
    - Local Institution
- New York
  - West Seneca, New York, United States
    - Local Institution
- North Carolina
  - Charlotte, North Carolina, United States
    - Local Institution
  - Morehead City, 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
  - sPARTA, North Carolina, United States
    - Local Institution
- Ohio
  - Cincinnati, Ohio, United States
    - Local Institution
  - Columbus, Ohio, United States
    - Local Institution
  - Lyndhurst, Ohio, United States
    - Local Institution
  - Youngstown, Ohio, United States
    - Local Institution
  - Zanesville, Ohio, United States
    - Local Institution
  - nEWARK, Ohio, United States
    - Local Institution
- Oklahoma
  - Oklahoma City, Oklahoma, United States
    - Local Institution
  - Tulsa, Oklahoma, United States
    - Local Institution
- Oregon
  - Eugene, Oregon, United States
    - Local Institution
  - Portland, Oregon, United States
    - Local Institution
- Pennsylvania
  - Fleetwood, Pennsylvania, United States
    - Local Institution
  - Philadelphia, Pennsylvania, United States
    - Local Institution
  - Pittsburgh, Pennsylvania, United States
    - Local Institution
  - West Chester, Pennsylvania, United States
    - Local Institution
  - cAMP hILL, Pennsylvania, United States
    - Local Institution
  - nORRISTOWN, Pennsylvania, United States
    - Local Institution
- Rhode Island
  - Providence, Rhode Island, United States
    - Local Institution
- South Carolina
  - Charleston, 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
  - Chattanooga, Tennessee, United States
    - Local Institution
  - Memphis, Tennessee, United States
    - Local Institution
- Texas
  - Austin, Texas, United States
    - Local Institution
  - Bryan, Texas, United States
    - Local Institution
  - Corpus Christi, Texas, United States
    - Local Institution
  - Dallas, Texas, United States
    - Local Institution
  - Midland, Texas, United States
    - Local Institution
  - San Antonio, Texas, United States
    - Local Institution
  - hOUSTON, 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
  - Olympia, Washington, United States
    - Local Institution
  - Spokane, Washington, United States
    - Local Institution
  - Tacoma, Washington, United States
    - Local Institution
  - Wenatchee, Washington, 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening
HbA1c >or = 7% and < or = 10%
Fasting c-peptide > or = 1.0 umol
Body Mass Index < or = 41 kg/m2
Mean serum triglycerides < or = 600 mg/dl

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
Change in baseline HbA1c after 52 weeks

Secondary Outcome Measures

Outcome Measure
Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Merck Sharp & Dohme LLC

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

Rubin CJ, Ledeine JM, Fiedorek FT. Improvement of glycaemic and lipid profiles with muraglitazar plus metformin in patients with type 2 diabetes: an active-control trial with glimepiride. Diab Vasc Dis Res. 2008 Sep;5(3):168-76. doi: 10.3132/dvdr.2008.028.

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

February 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

October 29, 2004

First Submitted That Met QC Criteria

October 29, 2004

First Posted (Estimate)

November 1, 2004

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

Keywords

Diabetes

Additional Relevant MeSH Terms

Other Study ID Numbers

CV168-048

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.