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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: muraglitazar (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Primary outcome: Change in baseline HbA1c after 52 weeks

Secondary outcome: Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Local Institution, Buenos Aires, Argentina

Local Institution, Cordoba, Argentina

Local Institution, Mendoza, Argentina

Local Institution, Graz, Austria

Local Institution, Salzburg, Austria

Local Institution, Wien, Austria

Local Institution, Rio De Janeiro, Brazil

Local Institution, Sao Paulo, Brazil

Local Institution, Quebec, Canada

Local Institution, 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, Chai Wan, Hong Kong

Local Institution, Hong Kong, Hong Kong

Local Institution, Shatin, Hong Kong

Local Institution, Chihuahua, Mexico

Local Institution, Durango, Mexico

Local Institution, Arequipa, Peru

Local Institution, Lima, Peru

Local Institution, Cavite, Philippines

Local Institution, Cebu, Philippines

Local Institution, Manila, Philippines

Local Institution, Pasig City, Philippines

Local Institution, Quezon, Philippines

Local Institution, Gorzow Wielkopolski, Poland

Local Institution, Krakow, Poland

Local Institution, Stalowa Wola, Poland

Local Institution, Warszawa, Poland

Local Institution, Wroclaw, Poland

Local Institution, Zabrze, Poland

Local Institution, Mrokow, Poland

Local Institution, Carolina, Puerto Rico

Local Institution, Ponce, Puerto Rico

Local Institution, Rio Piedras, Puerto Rico

Local Institution, San Juan, Puerto Rico

Local Institution, Moscow, Russian Federation

Local Institution, Smolensk, Russian Federation

Local Institution, St. Petersburg, Russian Federation

Local Institution, Baden, Switzerland

Local Institution, Changhua, Taiwan

Local Institution, Hualien, Taiwan

Local Institution, Taichung, Taiwan

Local Institution, Tainan, Taiwan

Local Institution, Bangkok, Thailand

Local Institution, bIRMINGHAM, Alabama, United States

Local Institution, Red Deer, Alberta, Canada

Local Institution, Calgary, Alberta, Canada

Local Institution, Tucson, Arizona, United States

Local Institution, pHOENIX, Arizona, United States

Local Institution, MESA, Arizona, United States

Local Institution, LITTLE ROCK, Arkansas, United States

Local Institution, Fayetteville, Arkansas, United States

Local Institution, Jonesboro, Arkansas, United States

Local Institution, Sherwood, Arkansas, United States

Local Institution, Tijuana, Baja California, Mexico

Local Institution, Delta, British Columbia, Canada

Local Institution, Vancouver, British Columbia, Canada

Local Institution, NORTH VANCOUVER, British Columbia, Canada

Local Institution, Kelowna, British Columbia, Canada

Local Institution, 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, MISSION VIEJO, California, United States

Local Institution, SPRING VALLEY, California, United States

Local Institution, FRESNO, California, United States

Local Institution, nORTHRIDGE, California, United States

Local Institution, BELLFLOWER, California, United States

Local Institution, LONG BEACH, California, United States

Local Institution, ENCINO, California, United States

Local Institution, WALNUT CREEK, California, United States

Local Institution, HUNTINGTON BEACH, California, United States

Local Institution, PASADENA, California, United States

Local Institution, MORENO VALLEY, California, United States

Local Institution, Roseville, California, United States

Local Institution, Paramount, California, United States

Local Institution, Cudahy, California, United States

Local Institution, Torrance, California, United States

Local Institution, Artesia, California, United States

Local Institution, Fortaleza, Ceara, Brazil

Local Institution, COLORADO SPRINGS, Colorado, United States

Local Institution, DENVER, Colorado, United States

Local Institution, Aurora, Colorado, United States

Local Institution, Brasilia, Distrito Federal, Brazil

Local Institution, Mexico, Distrito Federal, Mexico

Local Institution, hOLLYWOOD, Florida, United States

Local Institution, New Port Richey, Florida, United States

Local Institution, FORT LAUDERDALE, Florida, United States

Local Institution, jACKSONVILLE, Florida, United States

Local Institution, KISSIMMEE, Florida, United States

Local Institution, LONGWOOD, Florida, United States

Local Institution, pEMBROKE pINES, Florida, United States

Local Institution, MIAMI, Florida, United States

Local Institution, TALLAHASSEE, Florida, United States

Local Institution, Ocala, Florida, United States

Local Institution, St Cloud, Florida, United States

Local Institution, Winter Park, Florida, United States

Local Institution, Altamonte Springs, Florida, United States

Local Institution, Ormond Beach, Florida, United States

Local Institution, Clearwater, Florida, United States

Local Institution, Palm Harbor, Florida, United States

Local Institution, St Augustine, Florida, United States

Local Institution, Deland, Florida, United States

Local Institution, BLUE RIDGE, Georgia, United States

Local Institution, Chicago Heights, Illinois, United States

Local Institution, Chicago, Illinois, United States

Local Institution, ELKHART, Indiana, United States

Local Institution, Guadalajara, Jalisco, Mexico

Local Institution, SLIDELL, Louisiana, United States

Local Institution, WINNIPEG, Manitoba, Canada

Local Institution, bALTIMORE, Maryland, United States

Local Institution, Towson, Maryland, United States

Local Institution, SWANSEA, Massachusetts, United States

Local Institution, Santiago, Metropolitana, Chile

Local Institution, ROLLING FORK, Mississippi, United States

Local Institution, FLORISSANT, Missouri, United States

Local Institution, KANSAS CITY, Missouri, United States

Local Institution, CHESTERFIELD, Missouri, United States

Local Institution, ST LOUIS, Missouri, United States

Local Institution, Excelsior Springs, Missouri, United States

Local Institution, Springfield, Missouri, United States

Local Institution, Cuernavaca, Morelos, Mexico

Local Institution, OMAHA, Nebraska, United States

Local Institution, TOMS RIVER, New Jersey, United States

Local Institution, ALBUQUERQUE, New Mexico, United States

Local Institution, WEST SENECA, New York, United States

Local Institution, St. John, Newfoundland and Labrador, Canada

Local Institution, Mount Pearl, Newfoundland and Labrador, Canada

Local Institution, sPARTA, North Carolina, United States

Local Institution, STATESVILLE, North Carolina, United States

Local Institution, WILMINGTON, North Carolina, United States

Local Institution, MOREHEAD CITY, North Carolina, United States

Local Institution, Raleigh, North Carolina, United States

Local Institution, Winston Salem, North Carolina, United States

Local Institution, Charlotte, North Carolina, United States

Local Institution, Monterrey, Nuevo Leon, Mexico

Local Institution, nEWARK, Ohio, United States

Local Institution, CINCINNATI, Ohio, United States

Local Institution, Youngstown, Ohio, United States

Local Institution, Lyndhurst, Ohio, United States

Local Institution, Columbus, Ohio, United States

Local Institution, Zanesville, Ohio, United States

Local Institution, TULSA, Oklahoma, United States

Local Institution, OKLAHOMA CITY, Oklahoma, United States

Local Institution, Oshawa, Ontario, Canada

Local Institution, London, Ontario, Canada

Local Institution, Peterborough, Ontario, Canada

Local Institution, North York, Ontario, Canada

Local Institution, Woodstock, Ontario, Canada

Local Institution, York, Ontario, Canada

Local Institution, TORONTO, Ontario, Canada

Local Institution, Sarnia, Ontario, Canada

Local Institution, Portland, Oregon, United States

Local Institution, Eugene, Oregon, United States

Local Institution, Curitiba, Parana, Brazil

Local Institution, cAMP hILL, Pennsylvania, United States

Local Institution, nORRISTOWN, Pennsylvania, United States

Local Institution, PHILADELPHIA, Pennsylvania, United States

Local Institution, PITTSBURGH, Pennsylvania, United States

Local Institution, West Chester, Pennsylvania, United States

Local Institution, Fleetwood, Pennsylvania, United States

Local Institution, Charlottetown, Prince Edward Island, Canada

Local Institution, Granby, Quebec, Canada

Local Institution, Saint-Lambert, Quebec, Canada

Local Institution, Drummondville, Quebec, Canada

Local Institution, Longueuil, Quebec, Canada

Local Institution, mONTREAL, Quebec, Canada

Local Institution, Chicoutimi, Quebec, Canada

Local Institution, Fleurimont, Quebec, Canada

Local Institution, Ste-Foy, Quebec, Canada

Local Institution, Greenfield Park, Quebec, Canada

Local Institution, PROVIDENCE, Rhode Island, United States

Local Institution, Porto Alegre, Rio Grande Do Sul, Brazil

Local Institution, Campinas, Sao Paulo, Brazil

Local Institution, Marilia, Sao Paulo, Brazil

Local Institution, Saskatoon, Saskatchewan, Canada

Local Institution, sIMPSONVILLE, South Carolina, United States

Local Institution, GREER, South Carolina, United States

Local Institution, CHARLESTON, South Carolina, United States

Local Institution, BRISTOL, Tennessee, United States

Local Institution, CHATTANOOGA, Tennessee, United States

Local Institution, MEMPHIS, Tennessee, United States

Local Institution, Chattanooga, Tennessee, United States

Local Institution, hOUSTON, Texas, United States

Local Institution, AUSTIN, Texas, United States

Local Institution, MIDLAND, Texas, United States

Local Institution, Bryan, Texas, United States

Local Institution, Corpus Christi, Texas, United States

Local Institution, Dallas, Texas, United States

Local Institution, San Antonio, Texas, United States

Local Institution, Salt Lake City, Utah, United States

Local Institution, RICHMOND, Virginia, United States

Local Institution, VIRGINIA BEACH, Virginia, United States

Local Institution, TACOMA, Washington, United States

Local Institution, SPOKANE, Washington, United States

Local Institution, WENATCHEE, Washington, United States

Local Institution, OLYMPIA, Washington, United States

Local Institution, Merida, Yucatan, Mexico

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: February 2004
Last updated: September 27, 2007