A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
NCT ID: NCT01715818
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE3
1999 participants
INTERVENTIONAL
2012-12-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aleglitazar
aleglitazar
150 mcg orally daily
Placebo
Placebo
matching aleglitazar placebo tablet orally daily
Interventions
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Placebo
matching aleglitazar placebo tablet orally daily
aleglitazar
150 mcg orally daily
Eligibility Criteria
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Inclusion Criteria
* Patients with glucose abnormalities based on one of the following A-B criteria:
A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities
* Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines
Exclusion Criteria
* Prior intolerance to a TDZ or fibrate
* Previous participation in a trial with aleglitazar
* Other types of diabetes
* Inadequate liver, hematologic or renal function
* Symptomatic heart failure classified as NYHA class II-IV
* Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
* Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
* History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
* Currently scheduled for arterial revascularization procedures
* Systemic corticosteroid therapy for \> 2 weeks within 3 months prior to screening
* Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
40 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Mortimer, , United Kingdom
Reading, , United Kingdom
Soham, Ely, , United Kingdom
Armadale, Western Australia, Australia
Perth, Western Australia, Australia
Braunau am Inn, , Austria
Feldkirch, , Austria
Graz, , Austria
Vienna, , Austria
Kelowna, British Columbia, Canada
Surrey, British Columbia, Canada
Winnipeg, Manitoba, Canada
Bathurst, New Brunswick, Canada
Cambridge, Ontario, Canada
Collingwood, Ontario, Canada
Greater Sudbury, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Newmarket, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Quebec, Prince Edward Island, Canada
Chicoutimi, Quebec, Canada
Chicoutimi, Quebec, Canada
Granby, Quebec, Canada
Lachine, Quebec, Canada
Laval, Quebec, Canada
Longueuil, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saint-Charles-Borromée, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Saint-Lambert, Quebec, Canada
Sherbrooke, Quebec, Canada
Ste-Foy, Quebec, Canada
Terrebonne, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Las Condes, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Temuco, , Chile
Temuco, , Chile
Barranquila, , Colombia
Barranquilla, , Colombia
Bogotá, , Colombia
Cartagena, , Colombia
Floridablanca, , Colombia
Medellín, , Colombia
Beroun, , Czechia
Brno, , Czechia
Brno, , Czechia
Jihlava, , Czechia
Liberec, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Praha 4 - Krc, , Czechia
Slaný, , Czechia
Třebíč, , Czechia
Narva, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Tartu, , Estonia
Berlin, , Germany
Berlin, , Germany
Bochum, , Germany
Charlottenburg, , Germany
Chemnitz, , Germany
Cologne, , Germany
Damme, , Germany
Dresden, , Germany
Frankfurt, , Germany
Frankfurt, , Germany
Hanover, , Germany
Homburg/Saar, , Germany
Kassel, , Germany
Köthen, , Germany
Leipzig, , Germany
Magdeburg, , Germany
Mönchengladbach, , Germany
Münster, , Germany
Neunkirchen, , Germany
Wangen, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyöngyös, , Hungary
Mosonmagyaróvár, , Hungary
Nyíregyháza, , Hungary
Pápa, , Hungary
Szeged, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Zalaegerszeg, , Hungary
Giv‘atayim, , Israel
Naples, Campania, Italy
Napoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Catania, Sicily, Italy
Palermo, Sicily, Italy
Pesaro, The Marches, Italy
Massa, Tuscany, Italy
Tochigi, , Japan
Liepāja, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Vilnius, , Lithuania
Johor Bahru, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Selangor, , Malaysia
Perak, , Malaysia
Sabak Bernam, , Malaysia
Sarawak, , Malaysia
Aguascalientes, , Mexico
México, , Mexico
Monclova, , Mexico
Monterrey, , Mexico
Xalapa, , Mexico
Bialystok, , Poland
Gdynia, , Poland
Gdynia, , Poland
Katowice, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Lublin, , Poland
Nowy Sącz, , Poland
Opole, , Poland
Rzeszów, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Baia Mare, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Craiova, , Romania
Oradea, , Romania
Ploieşti, , Romania
Târgu Mureş, , Romania
Kemerovo, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Pretoria, , South Africa
Pretoria West, , South Africa
Busan, , South Korea
Busan, , South Korea
Daejeon, , South Korea
Gwangju, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Wŏnju, , South Korea
Albacete, Albacete, Spain
Sant Joan d'Alacant, Alicante, Spain
Almería, Almeria, Spain
Palma de Mallorca, Balearic Islands, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Girona, Girona, Spain
Granada, Granada, Spain
Huelva, Huelva, Spain
Santiago de Compostela, La Coruña, Spain
Lleida, Lerida, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Málaga, Malaga, Spain
Málaga, Malaga, Spain
Seville, Sevilla, Spain
Tarragona, Tarragona, Spain
Alzira, Valencia, Spain
Valencia, Valencia, Spain
Malmo, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Bangkok, , Thailand
Khon Kaen, , Thailand
Birmingham, , United Kingdom
Cardiff, , United Kingdom
Chorley, , United Kingdom
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
Glasgow, , United Kingdom
Inverness, , United Kingdom
Liverpool, , United Kingdom
Liverpool, , United Kingdom
Manchester, , United Kingdom
Muscle Shoals, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Cudahy, California, United States
Encino, California, United States
Fresno, California, United States
Fresno, California, United States
Hawaiian Gardens, California, United States
Huntington Beach, California, United States
Lomita, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
North Hollywood, California, United States
Northridge, California, United States
Roseville, California, United States
Sacramento, California, United States
San Diego, California, United States
Stockton, California, United States
Thousand Oaks, California, United States
Torrance, California, United States
Tustin, California, United States
Ventura, California, United States
Denver, Colorado, United States
Atlantis, Florida, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Panama City, Florida, United States
Pinellas Park, Florida, United States
Port Charlotte, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Augusta, Georgia, United States
Decatur, Georgia, United States
Dunwoody, Georgia, United States
Eagle, Idaho, United States
Idaho Falls, Idaho, United States
Melrose Park, Illinois, United States
Brownsburg, Indiana, United States
Evansville, Indiana, United States
Valparaiso, Indiana, United States
Council Bluffs, Iowa, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Alexandria, Louisiana, United States
Bangor, Maine, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Oxon Hill, Maryland, United States
Haverhill, Massachusetts, United States
Traverse City, Michigan, United States
Fall Rivers, Mississippi, United States
Kansas City, Missouri, United States
Bellevue, Nebraska, United States
Fremont, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Elizabeth, New Jersey, United States
Albany, New York, United States
North Massapequa, New York, United States
Smithtown, New York, United States
Syracuse, New York, United States
Westfield, New York, United States
Elizabeth City, North Carolina, United States
Morganton, North Carolina, United States
Raleigh, North Carolina, United States
Shelby, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Akron, Ohio, United States
Gallipolis, Ohio, United States
Kettering, Ohio, United States
Zanesville, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Beaver, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Fleetwood, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Clinton, South Carolina, United States
Greer, South Carolina, United States
Murrells Inlet, South Carolina, United States
Varnville, South Carolina, United States
Dakota Dunes, South Dakota, United States
Chattanooga, Tennessee, United States
Chattanooga, Tennessee, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Kingwood, Texas, United States
McAllen, Texas, United States
New Braunfels, Texas, United States
North Richland Hills, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Bountiful, Utah, United States
Draper, Utah, United States
Murray, Utah, United States
Salt Lake City, Utah, United States
Burke, Virginia, United States
Manassas, Virginia, United States
Suffolk, Virginia, United States
Port Orchard, Washington, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Caba, , Argentina
Caba, , Argentina
Camperdown, New South Wales, Australia
Gosford, New South Wales, Australia
Kogarah, New South Wales, Australia
Wollongong, New South Wales, Australia
South Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
Woodville, South Australia, Australia
Launceston, Tasmania, Australia
Geelong, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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2012-000671-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BC28027
Identifier Type: -
Identifier Source: org_study_id