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

NCT00095030 | Completed Phase 3

• 1 other identifier: CV168-048
• Study Type: interventional
• Target: 1,752
• Locations: 17 countries
• Sites: 206

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in baseline HbA1c after 52 weeks

Secondary Outcomes (1)

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

Interventions

muraglitazar DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (206)

Local Institution

Birmingham, 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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Fayetteville, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Sherwood, Arkansas, United States

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Artesia, California, United States

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Bellflower, California, United States

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Cudahy, California, United States

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Encino, California, United States

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Fresno, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Mission Viejo, California, United States

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Moreno Valley, California, United States

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Northridge, California, United States

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Paramount, California, United States

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Pasadena, California, United States

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Roseville, California, United States

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Spring Valley, California, United States

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Torrance, California, United States

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Walnut Creek, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Altamonte Springs, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Longwood, 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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Ocala, Florida, United States

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Ormond Beach, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Saint Augustine, Florida, United States

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Saint Cloud, Florida, United States

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Tallahassee, Florida, United States

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Winter Park, Florida, United States

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Blue Ridge, Georgia, United States

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Chicago, Illinois, United States

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Chicago Heights, Illinois, United States

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Elkhart, Indiana, United States

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Slidell, Louisiana, United States

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Baltimore, Maryland, United States

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Towson, Maryland, United States

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Swansea, Massachusetts, United States

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Rolling Fork, Mississippi, United States

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Chesterfield, Missouri, United States

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Excelsior Springs, Missouri, United States

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Florissant, Missouri, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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West Seneca, New York, United States

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Charlotte, North Carolina, United States

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Morehead City, North Carolina, United States

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Raleigh, North Carolina, United States

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Sparta, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Lyndhurst, Ohio, United States

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Newark, Ohio, United States

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Youngstown, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Fleetwood, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Bryan, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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Capital Federal, Buenos Aires, Argentina

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Chacabuco, Buenos Aires, Argentina

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El Palomar, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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San Martín, Buenos Aires, Argentina

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Buenos Aires, Argentina

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Córdoba, Argentina

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Mendoza, Argentina

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Graz, Austria

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Salzburg, Austria

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Vienna, Austria

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Fortaleza, Ceará, Brazil

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Brasília, Federal District, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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Marília, São Paulo, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Red Deer, Alberta, Canada

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Delta, British Columbia, Canada

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Kelowna, British Columbia, Canada

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North Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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London, Ontario, Canada

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North York, Ontario, Canada

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Oshawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Woodstock, Ontario, Canada

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York, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Chicoutimi, Quebec, Canada

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Drummondville, Quebec, Canada

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Fleurimont, Quebec, Canada

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Granby, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Longueuil, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Lambert, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Santiago, Santiago Metropolitan, Chile

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Künzing, Germany

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Magdeburg, Germany

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München, Germany

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Nuremberg, Germany

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Rodgau, Germany

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Rotenburg / Fulda, Germany

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Schönebeck, Germany

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Ulm, Germany

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Viernheim, Germany

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Vs-Schwenningen, Germany

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Witten, Germany

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Chai Wan, Hong Kong

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Hong Kong, Hong Kong

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Shatin, Hong Kong

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Tijuana, Estado de Baja California, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Cuernavaca, Morelos, Mexico

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Monterrey, Nuevo León, Mexico

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Mérida, Yucatán, Mexico

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Chihuahua City, Mexico

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Durango, Mexico

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Arequipa, Peru

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Lima, Peru

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Cavite, Philippines

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Cebu, Philippines

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Manila, Philippines

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Pasig, Philippines

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Quezon, Philippines

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Gorzów Wielkopolski, Poland

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Krakow, Poland

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Mroków, Poland

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Stalowa Wola, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Zabrze, Poland

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Carolina, Puerto Rico

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Ponce, Puerto Rico

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Rio Piedras, Puerto Rico

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San Juan, Puerto Rico

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Moscow, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Baden, Switzerland

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Changhua, Taiwan

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Hualien City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Bangkok, Thailand

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Related Publications (1)

• 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.

  PMID: 18777489 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

muraglitazar

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2004
• First Posted: November 1, 2004
• Study Start: February 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: September 14, 2010

Record last verified: 2007-09

Locations

AU (3); CL (1); RU (3); US (108); HK (3); ME (8); CH (1); TH (1); DE (11); PH (5); BR (8); PR (4); CA (29); TW (4); AR (8); PL (7); PE (2)