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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000671-16 | EudraCT Number |
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This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aleglitazar | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | matching aleglitazar placebo tablet orally daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) | 5 years | |
| Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) |
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Inclusion 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muscle Shoals | Alabama | 35662 | United States | |||
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| aleglitazar |
| Drug |
150 mcg orally daily |
|
| 5 years |
| Gilbert |
| Arizona |
| 85295 |
| United States |
| Phoenix | Arizona | 85018 | United States |
| Tucson | Arizona | 85724 | United States |
| Cudahy | California | 90201 | United States |
| Encino | California | 91436 | United States |
| Fresno | California | 93720 | United States |
| Fresno | California | 93721 | United States |
| Hawaiian Gardens | California | 90716 | United States |
| Huntington Beach | California | 92646 | United States |
| Lomita | California | 90717 | United States |
| Long Beach | California | 90807 | United States |
| Los Angeles | California | 90017 | United States |
| Los Angeles | California | 90036 | United States |
| Los Angeles | California | 90057 | United States |
| Los Gatos | California | 95032 | United States |
| North Hollywood | California | 91606 | United States |
| Northridge | California | 91325 | United States |
| Roseville | California | 95661 | United States |
| Sacramento | California | 95821 | United States |
| San Diego | California | 92103 | United States |
| Stockton | California | 95207 | United States |
| Thousand Oaks | California | 91360 | United States |
| Torrance | California | 90502 | United States |
| Tustin | California | 92780 | United States |
| Ventura | California | 90265 | United States |
| Denver | Colorado | 80209 | United States |
| Atlantis | Florida | 33462 | United States |
| Bradenton | Florida | 34208 | United States |
| Brooksville | Florida | 34601 | United States |
| Clearwater | Florida | 33755 | United States |
| Clearwater | Florida | 33756 | United States |
| DeLand | Florida | 32720 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Hialeah | Florida | 33012 | United States |
| Hialeah | Florida | 33013 | United States |
| Kissimmee | Florida | 34741 | United States |
| Miami | Florida | 33135 | United States |
| Miami | Florida | 33144 | United States |
| Miami Beach | Florida | 33140 | United States |
| New Port Richey | Florida | 34652 | United States |
| Orlando | Florida | 32822 | United States |
| Panama City | Florida | 32401 | United States |
| Pinellas Park | Florida | 33781 | United States |
| Port Charlotte | Florida | 33952 | United States |
| Sarasota | Florida | 34239 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Tampa | Florida | 33613 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Winter Park | Florida | 32789 | United States |
| Augusta | Georgia | 30909 | United States |
| Decatur | Georgia | 30030 | United States |
| Dunwoody | Georgia | 30338 | United States |
| Eagle | Idaho | 83616 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Melrose Park | Illinois | 60160 | United States |
| Brownsburg | Indiana | 46112 | United States |
| Evansville | Indiana | 47714 | United States |
| Valparaiso | Indiana | 46383 | United States |
| Council Bluffs | Iowa | 51501 | United States |
| Iowa City | Iowa | 52242 | United States |
| Wichita | Kansas | 67203 | United States |
| Lexington | Kentucky | 40504 | United States |
| Louisville | Kentucky | 40213 | United States |
| Owensboro | Kentucky | 42303 | United States |
| Alexandria | Louisiana | 71301 | United States |
| Bangor | Maine | 04401 | United States |
| Baltimore | Maryland | 21201 | United States |
| Baltimore | Maryland | 21209 | United States |
| Baltimore | Maryland | 21215 | United States |
| Oxon Hill | Maryland | 20745 | United States |
| Haverhill | Massachusetts | 01830 | United States |
| Traverse City | Michigan | 49684 | United States |
| Fall Rivers | Mississippi | 02720 | United States |
| Kansas City | Missouri | 64111 | United States |
| Bellevue | Nebraska | 68005 | United States |
| Fremont | Nebraska | 68025 | United States |
| Las Vegas | Nevada | 89106 | United States |
| Las Vegas | Nevada | 89121 | United States |
| Las Vegas | Nevada | 89123 | United States |
| Elizabeth | New Jersey | 07202 | United States |
| Albany | New York | 12206-1098 | United States |
| North Massapequa | New York | 11758 | United States |
| Smithtown | New York | 11787 | United States |
| Syracuse | New York | 13202 | United States |
| Westfield | New York | 14787 | United States |
| Elizabeth City | North Carolina | 27909 | United States |
| Morganton | North Carolina | 28655 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Shelby | North Carolina | 28150 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58103 | United States |
| Akron | Ohio | 44313 | United States |
| Gallipolis | Ohio | 45631 | United States |
| Kettering | Ohio | 45429 | United States |
| Zanesville | Ohio | 43701 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Tulsa | Oklahoma | 74104 | United States |
| Portland | Oregon | 97220 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Doylestown | Pennsylvania | 18901 | United States |
| Fleetwood | Pennsylvania | 19522 | United States |
| Harleysville | Pennsylvania | 19438 | United States |
| Jersey Shore | Pennsylvania | 17740 | United States |
| Lansdale | Pennsylvania | 19446 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Pittsburgh | Pennsylvania | 15202 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Uniontown | Pennsylvania | 15401 | United States |
| Clinton | South Carolina | 29325 | United States |
| Greer | South Carolina | 29651 | United States |
| Murrells Inlet | South Carolina | 29576 | United States |
| Varnville | South Carolina | 29944 | United States |
| Dakota Dunes | South Dakota | 57049 | United States |
| Chattanooga | Tennessee | 37404-3230 | United States |
| Chattanooga | Tennessee | 37411 | United States |
| Jackson | Tennessee | 38305 | United States |
| Knoxville | Tennessee | 27912 | United States |
| Nashville | Tennessee | 37203 | United States |
| Arlington | Texas | 76012 | United States |
| Corpus Christi | Texas | 78404 | United States |
| Dallas | Texas | 75230 | United States |
| El Paso | Texas | 79925 | United States |
| Houston | Texas | 77030 | United States |
| Houston | Texas | 77036 | United States |
| Houston | Texas | 77074 | United States |
| Kingwood | Texas | 77339 | United States |
| McAllen | Texas | 78501 | United States |
| New Braunfels | Texas | 78130 | United States |
| North Richland Hills | Texas | 76180 | United States |
| San Antonio | Texas | 78224 | United States |
| San Antonio | Texas | 78229 | United States |
| Tyler | Texas | 75701 | United States |
| Bountiful | Utah | 84010 | United States |
| Draper | Utah | 84020 | United States |
| Murray | Utah | 84123 | United States |
| Salt Lake City | Utah | 84124 | United States |
| Burke | Virginia | 22015 | United States |
| Manassas | Virginia | 20110 | United States |
| Suffolk | Virginia | 23435 | United States |
| Port Orchard | Washington | 98366 | United States |
| Spokane | Washington | 99207 | United States |
| Madison | Wisconsin | 53719 | United States |
| Caba | C1119ACN | Argentina |
| Caba | C1428DCO | Argentina |
| Camperdown | New South Wales | 2050 | Australia |
| Gosford | New South Wales | 2250 | Australia |
| Kogarah | New South Wales | 2217 | Australia |
| Wollongong | New South Wales | 2500 | Australia |
| South Brisbane | Queensland | 4101 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Woodville | South Australia | 5011 | Australia |
| Launceston | Tasmania | 7250 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Heidelberg | Victoria | 3081 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| Armadale | Western Australia | 6112 | Australia |
| Perth | Western Australia | 6009 | Australia |
| Braunau am Inn | 5280 | Austria |
| Feldkirch | 6800 | Austria |
| Graz | 8036 | Austria |
| Vienna | 1130 | Austria |
| Kelowna | British Columbia | V1Y 1E4 | Canada |
| Surrey | British Columbia | V3V 1Z2 | Canada |
| Winnipeg | Manitoba | R3E 3P4 | Canada |
| Bathurst | New Brunswick | E2A 4X7 | Canada |
| Cambridge | Ontario | N1R 6V6 | Canada |
| Collingwood | Ontario | L9Y 1W3 | Canada |
| Greater Sudbury | Ontario | P3C 5K7 | Canada |
| Hamilton | Ontario | L8L 2X2 | Canada |
| London | Ontario | N5W 6A2 | Canada |
| London | Ontario | N6G 0J4 | Canada |
| Newmarket | Ontario | L3Y 5G8 | Canada |
| Newmarket | Ontario | L3Y 8C3 | Canada |
| Sarnia | Ontario | N7T 4X3 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Toronto | Ontario | M9V 4B4 | Canada |
| Quebec | Prince Edward Island | G1V 4G2 | Canada |
| Chicoutimi | Quebec | G7H 5H6 | Canada |
| Chicoutimi | Quebec | G7H 7Y8 | Canada |
| Granby | Quebec | J2G 8Z9 | Canada |
| Lachine | Quebec | H8S 2E4 | Canada |
| Laval | Quebec | H7M 3L9 | Canada |
| Longueuil | Quebec | J4M 2X1 | Canada |
| Montreal | Quebec | H1T 1C8 | Canada |
| Montreal | Quebec | H1T 3Y7 | Canada |
| Montreal | Quebec | H2P 2M1 | Canada |
| Montreal | Quebec | H3G 1A4 | Canada |
| Montreal | Quebec | H4N 2W2 | Canada |
| Québec | Quebec | G3K 2P8 | Canada |
| Saint-Charles-Borromée | Quebec | J6E 6J2 | Canada |
| Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Saint-Lambert | Quebec | J4P 2H4 | Canada |
| Sherbrooke | Quebec | J1H 5N4 | Canada |
| Ste-Foy | Quebec | G1W 4R4 | Canada |
| Terrebonne | Quebec | J6V 1S8 | Canada |
| Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| Las Condes | 7500710 | Chile |
| Santiago | 7500010 | Chile |
| Santiago | 7500347 | Chile |
| Santiago | 7500710 | Chile |
| Temuco | 4781156 | Chile |
| Temuco | 4790869 | Chile |
| Temuco | 4813299 | Chile |
| Barranquila | Colombia |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Cartagena | Colombia |
| Floridablanca | Colombia |
| Medellín | Colombia |
| Beroun | 266 01 | Czechia |
| Brno | 601 77 | Czechia |
| Brno | 625 00 | Czechia |
| Jihlava | 586 33 | Czechia |
| Liberec | 460 63 | Czechia |
| Prague | 100 34 | Czechia |
| Prague | 128 08 | Czechia |
| Prague | 140 21 | Czechia |
| Prague | 140 59 | Czechia |
| Prague | 149 00 | Czechia |
| Prague | 150 06 | Czechia |
| Prague | 150 30 | Czechia |
| Prague | 158 00 | Czechia |
| Praha 4 - Krc | 140 59 | Czechia |
| Slaný | 274 51 | Czechia |
| Třebíč | 674 01 | Czechia |
| Narva | 20307 | Estonia |
| Tallinn | 10138 | Estonia |
| Tartu | 50410 | Estonia |
| Tartu | 51014 | Estonia |
| Berlin | 10117 | Germany |
| Berlin | 13125 | Germany |
| Bochum | 44787 | Germany |
| Charlottenburg | 14050 | Germany |
| Chemnitz | 09111 | Germany |
| Cologne | 50937 | Germany |
| Damme | 49401 | Germany |
| Dresden | 01067 | Germany |
| Frankfurt | 60596 | Germany |
| Frankfurt | 65929 | Germany |
| Hanover | 30159 | Germany |
| Homburg/Saar | 66421 | Germany |
| Kassel | 34121 | Germany |
| Köthen | 06366 | Germany |
| Leipzig | 04103 | Germany |
| Magdeburg | 39104 | Germany |
| Mönchengladbach | 41063 | Germany |
| Münster | 48145 | Germany |
| Neunkirchen | 66539 | Germany |
| Wangen | 88239 | Germany |
| Balatonfüred | 8230 | Hungary |
| Budapest | 1023 | Hungary |
| Budapest | 1027 | Hungary |
| Budapest | 1036 | Hungary |
| Budapest | 1085 | Hungary |
| Budapest | 1097 | Hungary |
| Budapest | 1125 | Hungary |
| Budapest | 1131 | Hungary |
| Debrecen | 4032 | Hungary |
| Gyöngyös | 3200 | Hungary |
| Mosonmagyaróvár | 9200 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Pápa | 8500 | Hungary |
| Szeged | 6720 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Szolnok | 5004 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Giv‘atayim | 53583 | Israel |
| Naples | Campania | 80122 | Italy |
| Naples | Campania | 80131 | Italy |
| Bologna | Emilia-Romagna | 40133 | Italy |
| Rome | Lazio | 00128 | Italy |
| Rome | Lazio | 00185 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Milan | Lombardy | 20138 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Catania | Sicily | 95122 | Italy |
| Palermo | Sicily | 90127 | Italy |
| Pesaro | The Marches | 61121 | Italy |
| Massa | Tuscany | 54100 | Italy |
| Tochigi | 329-0498 | Japan |
| Liepāja | 3400 | Latvia |
| Riga | LV-1002 | Latvia |
| Riga | LV-1012 | Latvia |
| Riga | LV-1024 | Latvia |
| Riga | LV-1058 | Latvia |
| Kaunas | 48259 | Lithuania |
| Kaunas | 50184 | Lithuania |
| Kaunas | LT-47144 | Lithuania |
| Vilnius | LT-02169 | Lithuania |
| Johor Bahru | 80100 | Malaysia |
| Kuala Lumpur | 59100 | Malaysia |
| Kuala Selangor | 68100 | Malaysia |
| Perak | 34000 | Malaysia |
| Sabak Bernam | 88300 | Malaysia |
| Sarawak | 94300 | Malaysia |
| Aguascalientes | 20234 | Mexico |
| México | 03300 | Mexico |
| Monclova | 25750 | Mexico |
| Monterrey | 64460 | Mexico |
| Xalapa | 91020 | Mexico |
| Bialystok | 15-276 | Poland |
| Gdynia | 81-384 | Poland |
| Gdynia | 81-472 | Poland |
| Katowice | 40-748 | Poland |
| Katowice | 40-954 | Poland |
| Krakow | 30-015 | Poland |
| Krakow | 30-082 | Poland |
| Krakow | 31-202 | Poland |
| Krakow | 31-261 | Poland |
| Lodz | 90-242 | Poland |
| Lublin | 20-044 | Poland |
| Lublin | 20-093 | Poland |
| Nowy Sącz | 33-300 | Poland |
| Opole | 45-367 | Poland |
| Rzeszów | 35-055 | Poland |
| Warsaw | 01-192 | Poland |
| Wroclaw | 50-088 | Poland |
| Baia Mare | 430123 | Romania |
| Bucharest | 010507 | Romania |
| Bucharest | 010825 | Romania |
| Bucharest | 020359 | Romania |
| Bucharest | 050098 | Romania |
| Bucharest | 061119 | Romania |
| Bucharest | 800578 | Romania |
| Craiova | 200642 | Romania |
| Oradea | 410169 | Romania |
| Ploieşti | 100163 | Romania |
| Târgu Mureş | 540124 | Romania |
| Kemerovo | Russia |
| Saint Petersburg | 199034 | Russia |
| Tomsk | 634012 | Russia |
| Pretoria | 0103 | South Africa |
| Pretoria West | 0183 | South Africa |
| Busan | 602-715 | South Korea |
| Busan | 602-739 | South Korea |
| Daejeon | 35015 | South Korea |
| Gwangju | 61469 | South Korea |
| Gyeonggi-do | 10380 | South Korea |
| Gyeonggi-do | 11765 | South Korea |
| Gyeonggi-do | 410-773 | South Korea |
| Gyeonggi-do | 431-070 | South Korea |
| Gyeonggi-do | 443-380 | South Korea |
| Incheon | 405-760 | South Korea |
| Seoul | 05030 | South Korea |
| Seoul | 06273 | South Korea |
| Seoul | 130-872 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 156-707 | South Korea |
| Suwon | 442-723 | South Korea |
| Wŏnju | 220-701 | South Korea |
| Albacete | Albacete | 02006 | Spain |
| Sant Joan d'Alacant | Alicante | 3550 | Spain |
| Almería | Almeria | 04009 | Spain |
| Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | Spain |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Girona | Girona | 17007 | Spain |
| Granada | Granada | 18012 | Spain |
| Huelva | Huelva | 21005 | Spain |
| Santiago de Compostela | La Coruña | 15706 | Spain |
| Lleida | Lerida | 25198 | Spain |
| Madrid | Madrid | 41013 | Spain |
| Málaga | Malaga | 29006 | Spain |
| Málaga | Malaga | 29009 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Seville | Sevilla | 41009 | Spain |
| Tarragona | Tarragona | 43007 | Spain |
| Alzira | Valencia | 46600 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Malmö | 205 02 | Sweden |
| Stockholm | 111 35 | Sweden |
| Stockholm | 113 61 | Sweden |
| Stockholm | 171 76 | Sweden |
| Bangkok | 10330 | Thailand |
| Khon Kaen | 40002 | Thailand |
| Birmingham | B15 2SQ | United Kingdom |
| Cardiff | CF14 5GJ | United Kingdom |
| Chorley | PR7 7NA | United Kingdom |
| Edinburgh | EH16 4TJ | United Kingdom |
| Glasgow | G12 8QQ | United Kingdom |
| Glasgow | G20 0SP | United Kingdom |
| Inverness | IV2 4AG | United Kingdom |
| Liverpool | L22 0LG | United Kingdom |
| Liverpool | L9 7AL | United Kingdom |
| Manchester | M15 6SX | United Kingdom |
| Mortimer | RG7 3SQ | United Kingdom |
| Reading | RG2 0TG | United Kingdom |
| Soham, Ely | CB7 5JD | United Kingdom |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C542437 | aleglitazar |
Not provided
Not provided
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