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

NCT ID: NCT00095030

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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muraglitazar

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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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 City, , Taiwan

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Bangkok, , Thailand

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Countries

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United States Argentina Austria Brazil Canada Chile Germany Hong Kong Mexico Peru Philippines Poland Puerto Rico Russia Switzerland Taiwan Thailand

References

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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.

Reference Type DERIVED
PMID: 18777489 (View on PubMed)

Other Identifiers

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CV168-048

Identifier Type: -

Identifier Source: org_study_id