Diabetes Mellitus, Type 2 Clinical Trial
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
| Verified date | September 2007 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1752 |
| Est. completion date | March 2006 |
| Est. primary completion date | March 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Buenos Aires | |
| Argentina | Local Institution | Capital Federal | Buenos Aires |
| Argentina | Local Institution | Chacabuco | Buenos Aires |
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | El Palomar | Buenos Aires |
| Argentina | Local Institution | Mar Del Plata | Buenos Aires |
| Argentina | Local Institution | Mendoza | |
| Argentina | Local Institution | San Martin | Buenos Aires |
| Austria | Local Institution | Graz | |
| Austria | Local Institution | Salzburg | |
| Austria | Local Institution | Wien | |
| Brazil | Local Institution | Brasilia | Distrito Federal |
| Brazil | Local Institution | Campinas | Sao Paulo |
| Brazil | Local Institution | Curitiba | Parana |
| Brazil | Local Institution | Fortaleza | Ceara |
| Brazil | Local Institution | Marilia | Sao Paulo |
| Brazil | Local Institution | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution | Rio De Janeiro | |
| Brazil | Local Institution | Sao Paulo | |
| Canada | Local Institution | Calgary | Alberta |
| Canada | Local Institution | Charlottetown | Prince Edward Island |
| Canada | Local Institution | Chicoutimi | Quebec |
| Canada | Local Institution | Delta | British Columbia |
| Canada | Local Institution | Drummondville | Quebec |
| Canada | Local Institution | Fleurimont | Quebec |
| Canada | Local Institution | Granby | Quebec |
| Canada | Local Institution | Greenfield Park | Quebec |
| Canada | Local Institution | Kelowna | British Columbia |
| Canada | Local Institution | London | Ontario |
| Canada | Local Institution | Longueuil | Quebec |
| Canada | Local Institution | mONTREAL | Quebec |
| Canada | Local Institution | Mount Pearl | Newfoundland and Labrador |
| Canada | Local Institution | North Vancouver | British Columbia |
| Canada | Local Institution | North York | Ontario |
| Canada | Local Institution | Oshawa | Ontario |
| Canada | Local Institution | Peterborough | Ontario |
| Canada | Local Institution | Quebec | |
| Canada | Local Institution | Red Deer | Alberta |
| Canada | Local Institution | Saint-Lambert | Quebec |
| Canada | Local Institution | Sarnia | Ontario |
| Canada | Local Institution | Saskatoon | Saskatchewan |
| Canada | Local Institution | St. John | Newfoundland and Labrador |
| Canada | Local Institution | Ste-Foy | Quebec |
| Canada | Local Institution | Toronto | Ontario |
| Canada | Local Institution | Vancouver | British Columbia |
| Canada | Local Institution | Winnipeg | Manitoba |
| Canada | Local Institution | Woodstock | Ontario |
| Canada | Local Institution | York | Ontario |
| Chile | Local Institution | Santiago | Metropolitana |
| Germany | 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 | |
| Hong Kong | Local Institution | Chai Wan | |
| Hong Kong | Local Institution | Hong Kong | |
| Hong Kong | Local Institution | Shatin | |
| Mexico | Local Institution | Chihuahua | |
| Mexico | Local Institution | Cuernavaca | Morelos |
| Mexico | Local Institution | Durango | |
| Mexico | Local Institution | Guadalajara | Jalisco |
| Mexico | Local Institution | Merida | Yucatan |
| Mexico | Local Institution | Mexico | Distrito Federal |
| Mexico | Local Institution | Monterrey | Nuevo Leon |
| Mexico | Local Institution | Tijuana | Baja California |
| Peru | Local Institution | Arequipa | |
| Peru | Local Institution | Lima | |
| Philippines | Local Institution | Cavite | |
| Philippines | Local Institution | Cebu | |
| Philippines | Local Institution | Manila | |
| Philippines | Local Institution | Pasig City | |
| Philippines | Local Institution | Quezon | |
| Poland | Local Institution | 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 | |
| Puerto Rico | Local Institution | Carolina | |
| Puerto Rico | Local Institution | Ponce | |
| Puerto Rico | Local Institution | Rio Piedras | |
| Puerto Rico | Local Institution | San Juan | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | Smolensk | |
| Russian Federation | Local Institution | St. Petersburg | |
| Switzerland | Local Institution | Baden | |
| Taiwan | Local Institution | Changhua | |
| Taiwan | Local Institution | Hualien | |
| Taiwan | Local Institution | Taichung | |
| Taiwan | Local Institution | Tainan | |
| Thailand | Local Institution | Bangkok | |
| United States | Local Institution | Albuquerque | New Mexico |
| United States | Local Institution | Altamonte Springs | Florida |
| United States | Local Institution | Artesia | California |
| United States | Local Institution | Aurora | Colorado |
| United States | Local Institution | Austin | Texas |
| United States | Local Institution | bALTIMORE | Maryland |
| United States | Local Institution | Bellflower | California |
| United States | Local Institution | bIRMINGHAM | Alabama |
| United States | Local Institution | Blue Ridge | Georgia |
| United States | Local Institution | Bristol | Tennessee |
| United States | Local Institution | Bryan | Texas |
| United States | Local Institution | cAMP hILL | Pennsylvania |
| United States | Local Institution | Charleston | South Carolina |
| United States | Local Institution | Charlotte | North Carolina |
| United States | Local Institution | Chattanooga | Tennessee |
| United States | Local Institution | Chesterfield | Missouri |
| United States | Local Institution | Chicago | Illinois |
| United States | Local Institution | Chicago Heights | Illinois |
| United States | Local Institution | Cincinnati | Ohio |
| United States | Local Institution | Clearwater | Florida |
| United States | Local Institution | Colorado Springs | Colorado |
| United States | Local Institution | Columbus | Ohio |
| United States | Local Institution | Corpus Christi | Texas |
| United States | Local Institution | Cudahy | California |
| United States | Local Institution | Dallas | Texas |
| United States | Local Institution | Deland | Florida |
| United States | Local Institution | Denver | Colorado |
| United States | Local Institution | Elkhart | Indiana |
| United States | Local Institution | Encino | California |
| United States | Local Institution | Eugene | Oregon |
| United States | Local Institution | Excelsior Springs | Missouri |
| United States | Local Institution | Fayetteville | Arkansas |
| United States | Local Institution | Fleetwood | Pennsylvania |
| United States | Local Institution | Florissant | Missouri |
| United States | Local Institution | Fort Lauderdale | Florida |
| United States | Local Institution | Fresno | California |
| United States | Local Institution | Greer | South Carolina |
| United States | Local Institution | hOLLYWOOD | Florida |
| United States | Local Institution | hOUSTON | Texas |
| United States | Local Institution | Huntington Beach | California |
| United States | Local Institution | jACKSONVILLE | Florida |
| United States | Local Institution | Jonesboro | Arkansas |
| United States | Local Institution | Kansas City | Missouri |
| United States | Local Institution | Kissimmee | Florida |
| United States | Local Institution | Little Rock | Arkansas |
| United States | Local Institution | Long Beach | California |
| United States | Local Institution | Longwood | Florida |
| United States | Local Institution | Lyndhurst | Ohio |
| United States | Local Institution | Memphis | Tennessee |
| United States | Local Institution | Mesa | Arizona |
| United States | Local Institution | Miami | Florida |
| United States | Local Institution | Midland | Texas |
| United States | Local Institution | Mission Viejo | California |
| United States | Local Institution | Morehead City | North Carolina |
| United States | Local Institution | Moreno Valley | California |
| United States | Local Institution | New Port Richey | Florida |
| United States | Local Institution | nEWARK | Ohio |
| United States | Local Institution | nORRISTOWN | Pennsylvania |
| United States | Local Institution | nORTHRIDGE | California |
| United States | Local Institution | Ocala | Florida |
| United States | Local Institution | Oklahoma City | Oklahoma |
| United States | Local Institution | Olympia | Washington |
| United States | Local Institution | Omaha | Nebraska |
| United States | Local Institution | Ormond Beach | Florida |
| United States | Local Institution | Palm Harbor | Florida |
| United States | Local Institution | Paramount | California |
| United States | Local Institution | Pasadena | California |
| United States | Local Institution | pEMBROKE pINES | Florida |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution | pHOENIX | Arizona |
| United States | Local Institution | Pittsburgh | Pennsylvania |
| United States | Local Institution | Portland | Oregon |
| United States | Local Institution | Providence | Rhode Island |
| United States | Local Institution | Raleigh | North Carolina |
| United States | Local Institution | Richmond | Virginia |
| United States | Local Institution | Rolling Fork | Mississippi |
| United States | Local Institution | Roseville | California |
| United States | Local Institution | Salt Lake City | Utah |
| United States | Local Institution | San Antonio | Texas |
| United States | Local Institution | Sherwood | Arkansas |
| United States | Local Institution | sIMPSONVILLE | South Carolina |
| United States | Local Institution | Slidell | Louisiana |
| United States | Local Institution | sPARTA | North Carolina |
| United States | Local Institution | Spokane | Washington |
| United States | Local Institution | Spring Valley | California |
| United States | Local Institution | Springfield | Missouri |
| United States | Local Institution | St Augustine | Florida |
| United States | Local Institution | St Cloud | Florida |
| United States | Local Institution | St Louis | Missouri |
| United States | Local Institution | Statesville | North Carolina |
| United States | Local Institution | Swansea | Massachusetts |
| United States | Local Institution | Tacoma | Washington |
| United States | Local Institution | Tallahassee | Florida |
| United States | Local Institution | Toms River | New Jersey |
| United States | Local Institution | Torrance | California |
| United States | Local Institution | Towson | Maryland |
| United States | Local Institution | Tucson | Arizona |
| United States | Local Institution | Tulsa | Oklahoma |
| United States | Local Institution | Virginia Beach | Virginia |
| United States | Local Institution | Walnut Creek | California |
| United States | Local Institution | Wenatchee | Washington |
| United States | Local Institution | West Chester | Pennsylvania |
| United States | Local Institution | West Seneca | New York |
| United States | Local Institution | Wilmington | North Carolina |
| United States | Local Institution | Winston Salem | North Carolina |
| United States | Local Institution | Winter Park | Florida |
| United States | Local Institution | Youngstown | Ohio |
| United States | Local Institution | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Merck Sharp & Dohme Corp. |
United States, Argentina, Austria, Brazil, Canada, Chile, Germany, Hong Kong, Mexico, Peru, Philippines, Poland, Puerto Rico, Russian Federation, Switzerland, Taiwan, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in baseline HbA1c after 52 weeks | |||
| Secondary | Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks |
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