Diabetes Mellitus, Type 2Phase 3NCT00095030
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone
A Phase 3 study testing muraglitazar in people with Diabetes Mellitus, Type 2, run by Bristol-Myers Squibb at 206 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- muraglitazar
- How many people
- 1,752 participants
- Where
- 206 sitesin 17 countries
- Study dates
- Feb 2004to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
206 sites in 17 countries.
206 sites in 17 countries
United States108 sites
Local Institution
Albuquerque, New Mexico
Local Institution
Altamonte Springs, Florida
Local Institution
Artesia, California
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Aurora, Colorado
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Austin, Texas
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Baltimore, Maryland
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Bellflower, California
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Birmingham, Alabama
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Blue Ridge, Georgia
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Bristol, Tennessee
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Bryan, Texas
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Camp Hill, Pennsylvania
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Charleston, South Carolina
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Charlotte, North Carolina
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Chattanooga, Tennessee
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Chesterfield, Missouri
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Chicago, Illinois
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Chicago Heights, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Colorado Springs, Colorado
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Columbus, Ohio
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Corpus Christi, Texas
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Cudahy, California
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Dallas, Texas
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DeLand, Florida
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Denver, Colorado
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Elkhart, Indiana
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Encino, California
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Eugene, Oregon
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Excelsior Springs, Missouri
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Fayetteville, Arkansas
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Fleetwood, Pennsylvania
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Florissant, Missouri
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Fort Lauderdale, Florida
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Fresno, California
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Greer, South Carolina
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Hollywood, Florida
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Houston, Texas
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Huntington Beach, California
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Jacksonville, Florida
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Jonesboro, Arkansas
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Kansas City, Missouri
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Kissimmee, Florida
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Little Rock, Arkansas
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Long Beach, California
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Longwood, Florida
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Lyndhurst, Ohio
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Memphis, Tennessee
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Mesa, Arizona
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Miami, Florida
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Midland, Texas
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Mission Viejo, California
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Morehead City, North Carolina
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Moreno Valley, California
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New Port Richey, Florida
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Newark, Ohio
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Norristown, Pennsylvania
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Northridge, California
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Ocala, Florida
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Oklahoma City, Oklahoma
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Olympia, Washington
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Omaha, Nebraska
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Ormond Beach, Florida
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Palm Harbor, Florida
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Paramount, California
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Pasadena, California
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Pembroke Pines, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Portland, Oregon
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Providence, Rhode Island
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Raleigh, North Carolina
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Richmond, Virginia
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Rolling Fork, Mississippi
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Roseville, California
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Saint Augustine, Florida
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Saint Cloud, Florida
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Salt Lake City, Utah
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San Antonio, Texas
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Sherwood, Arkansas
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Simpsonville, South Carolina
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Slidell, Louisiana
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Sparta, North Carolina
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Spokane, Washington
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Spring Valley, California
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Springfield, Missouri
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St Louis, Missouri
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Statesville, North Carolina
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Swansea, Massachusetts
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Tacoma, Washington
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Tallahassee, Florida
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Toms River, New Jersey
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Torrance, California
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Towson, Maryland
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Tucson, Arizona
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Tulsa, Oklahoma
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Virginia Beach, Virginia
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Walnut Creek, California
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Wenatchee, Washington
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West Chester, Pennsylvania
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West Seneca, New York
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Wilmington, North Carolina
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Winston-Salem, North Carolina
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Winter Park, Florida
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Youngstown, Ohio
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Zanesville, Ohio
Canada29 sites
Local Institution
Calgary, Alberta
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Charlottetown, Prince Edward Island
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Chicoutimi, Quebec
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Delta, British Columbia
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Drummondville, Quebec
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Fleurimont, Quebec
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Granby, Quebec
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Greenfield Park, Quebec
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Kelowna, British Columbia
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London, Ontario
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Longueuil, Quebec
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Montreal, Quebec
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Mount Pearl, Newfoundland and Labrador
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North Vancouver, British Columbia
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North York, Ontario
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Oshawa, Ontario
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Peterborough, Ontario
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Québec, Quebec
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Red Deer, Alberta
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Saint-Lambert, Quebec
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Sarnia, Ontario
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Saskatoon, Saskatchewan
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St. John's, Newfoundland and Labrador
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Ste-Foy, Quebec
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Toronto, Ontario
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Vancouver, British Columbia
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Winnipeg, Manitoba
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Woodstock, Ontario
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York, Ontario
Germany11 sites
Local Institution
Künzing
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Magdeburg
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München
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Nuremberg
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Rodgau
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Rotenburg / Fulda
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Schönebeck
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Ulm
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Viernheim
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Vs-Schwenningen
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Witten
Argentina8 sites
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Buenos Aires
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Capital Federal, Buenos Aires
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Chacabuco, Buenos Aires
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Córdoba
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El Palomar, Buenos Aires
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Mar del Plata, Buenos Aires
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Mendoza
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San Martín, Buenos Aires
Brazil8 sites
Local Institution
Brasília, Federal District
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Campinas, São Paulo
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Curitiba, Paraná
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Fortaleza, Ceará
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Marília, São Paulo
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Porto Alegre, Rio Grande do Sul
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Rio de Janeiro
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São Paulo
Mexico8 sites
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Chihuahua City
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Cuernavaca, Morelos
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Durango
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Guadalajara, Jalisco
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Mérida, Yucatán
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Mexico City, Mexico City
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Monterrey, Nuevo León
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Tijuana, Estado de Baja California
Poland7 sites
Local Institution
Gorzów Wielkopolski
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Krakow
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Mroków
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Stalowa Wola
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Warsaw
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Wroclaw
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Zabrze
Philippines5 sites
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Cavite
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Cebu
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Manila
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Pasig
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Quezon
Puerto Rico4 sites
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Carolina
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Ponce
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Rio Piedras
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San Juan
Taiwan4 sites
Local Institution
Changhua
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Hualien City
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Taichung
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Tainan
Austria3 sites
Local Institution
Graz
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Salzburg
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Vienna
Hong Kong3 sites
Local Institution
Chai Wan
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Hong Kong
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Shatin
Russia3 sites
Local Institution
Moscow
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Saint Petersburg
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Smolensk
About this study
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
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
- Being tested
- muraglitazar
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muraglitazarDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2004 (estimated)
- Study startFeb 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,752 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095030
- Sponsor's protocol ID
- CV168-048
- Status last verified
- Sep 2007
- First submitted
- 29 Oct 2004
- Last updated
- 14 Sep 2010
- Results posted
- No
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.
PubMed 18777489
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00095030
- Acronym / sponsor ID
- CV168-048
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,752 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 1 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muraglitazar | Drug | – |
Primary outcome
Change in baseline HbA1c after 52 weeks
1 secondary outcome
Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
- Derived from this study: PubMed 18777489Rubin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
206 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing muraglitazar in people with Diabetes Mellitus, Type 2, run by Bristol-Myers Squibb at 206 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 206 sites in United States, Canada, Germany, Argentina, Brazil and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline HbA1c after 52 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00095030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2010.