A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Aleglitazar; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 7226
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425AGC
  • Buenos Aires, Argentina, 1428
  • Buenos Aires, Argentina, 1425DES
  • Buenos Aires, Argentina, C1155ADP
  • Buenos Aires, Argentina, C1181ACH
  • Buenos Aires, Argentina, C1426AGU
  • Buenos Aires, Argentina, C1437BZL
  • Caba, Argentina, C1119ACN
  • Caba, Argentina, C1428DCO
  • Caba, Argentina, C1405BCK
  • Capital Federal, Argentina, 1180
  • Ciudad Autonoma Bs As, Argentina, C1280AEB
  • Cordoba, Argentina, 5000
  • Cordoba, Argentina, 5009
  • Cordoba, Argentina, X5000EPU
  • Coronel Suarez, Argentina, B7540GDH
  • Corrientes, Argentina, W3400AMZ
  • Haedo, Argentina, B1706AJU
  • Mendoza, Argentina, 5500
  • Moron, Argentina, 1708
  • Rosario, Argentina, 2000
  • Rosario, Argentina, S2000DIF
  • Rosario, Argentina, S2002OUR
  • Salta, Argentina, 4400
  • Santa Fe, Argentina, 3000
  • Santiago del Estero, Argentina, G4200AQK
  • Tucuman, Argentina, 4000
  • Zarate, Argentina, 2800
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
    • Concord, New South Wales, Australia, 2139
    • Darlinghurst, New South Wales, Australia, 2010
    • Liverpool BC, New South Wales, Australia, 1871
    • New Lambton, New South Wales, Australia, 2305
    • Penrith, New South Wales, Australia, 2751
    • St. Leonards, New South Wales, Australia, 2065
    • Sydney, New South Wales, Australia, 2217
    • Wollongong, New South Wales, Australia, 2500
  • Queensland
    • Douglas, Queensland, Australia, 4184
    • Milton, Queensland, Australia, 4064
    • Redcliffe, Queensland, Australia, 4020
    • Southport, Queensland, Australia, 4215
    • Woolloongabba, Queensland, Australia, 4102
  • South Australia
    • Adelaide, South Australia, Australia, 5000
    • Elizabeth Vale, South Australia, Australia, 5112
    • Woodville, South Australia, Australia, 5011
  • Victoria
    • Ballarat, Victoria, Australia, 3353
    • Geelong, Victoria, Australia, 3220
    • Richmond, Victoria, Australia, 3121
    • Shepparton, Victoria, Australia, 3630
• Brazil
  • BA
    • Salvador, BA, Brazil, 40010020
  • CE
    • Fortaleza, CE, Brazil, 60840285
    • Fortaleza, CE, Brazil, 60115282
    • Fortaleza, CE, Brazil, 60430-370
    • Fortaleza, CE, Brazil, 60430970
  • DF
    • Brasilia, DF, Brazil, 71625-009
  • ES
    • Cariacica, ES, Brazil, 29151920
  • GO
    • Goiania, GO, Brazil, 74823-470
  • MG
    • Belo Horizonte, MG, Brazil, 30150-221
    • Belo Horizonte, MG, Brazil, 30110-068
    • Belo Horizonte, MG, Brazil, 30150-240
    • Uberlandia, MG, Brazil, 38400-368
  • MS
    • Campo grande, MS, Brazil, 79070900
  • PE
    • Recife, PE, Brazil, 50100-060
  • PR
    • Campina Grande do Sul, PR, Brazil, 83430-000
    • Curitiba, PR, Brazil, 80220-000
    • Curitiba, PR, Brazil, 80320-320
    • Curitiba, PR, Brazil, 80730-150
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22271-100
    • Rio de Janeiro, RJ, Brazil, 22240-006
  • RN
    • Natal, RN, Brazil, 59020-100
  • RS
    • Passo Fundo, RS, Brazil, 99010-080
    • Porto Alegre, RS, Brazil, 90035-003
    • Porto Alegre, RS, Brazil, 90110-270
    • Porto Alegre, RS, Brazil, 90610-000
    • Porto Alegre, RS, Brazil, 91350-200
    • Porto Alegre, RS, Brazil, 90020-090
    • Porto Alegre, RS, Brazil, 90620-001
    • Porto Alegre, RS, Brazil, 90035-170
  • SC
    • Sao Jose, SC, Brazil, 88103-460
    • Sao Jose do Rio Preto, SC, Brazil, 15015-210
  • SP
    • Campinas, SP, Brazil, 13060-803
    • Campinas, SP, Brazil, 13024-011
    • Sao Jose do Rio Preto, SP, Brazil, 15090-000
    • Sao Paulo, SP, Brazil, 05403-000
    • Sao Paulo, SP, Brazil, 01244-030
    • Sao Paulo, SP, Brazil, 1506000
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
    • Edmonton, Alberta, Canada, T6G1Z1
    • Edmonton, Alberta, Canada, T6K 4C1
    • Red Deer, Alberta, Canada, T4N 6R2
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
    • Surrey, British Columbia, Canada, V3V 1Z2
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 1A9
    • Moncton, New Brunswick, Canada, E1G 1A7
    • Moncton, New Brunswick, Canada, E1L 2Z3
    • Saint John, New Brunswick, Canada, E2L 4L2
  • Newfoundland and Labrador
    • St Johns, Newfoundland and Labrador, Canada, A1E2C2
  • Nova Scotia
    • Bridgewater, Nova Scotia, Canada, B4V 3N2
    • Halifax, Nova Scotia, Canada, B3H 2Y9
  • Ontario
    • Brampton, Ontario, Canada, L6Z 4N5
    • Brampton, Ontario, Canada, L6W2X7
    • Burlington, Ontario, Canada, L7M 4Y1
    • Burlington, Ontario, Canada, L7R4EZ
    • Cambridge, Ontario, Canada, N1R 6V6
    • Cambridge, Ontario, Canada, N1R 7R1
    • Fort Eire, Ontario, Canada, L2A1Z3
    • Hamilton, Ontario, Canada, L8L 2X2
    • Kingston, Ontario, Canada, K7L 5G2
    • Kitchener, Ontario, Canada, N2M 1B2
    • London, Ontario, Canada, N6A 4L6
    • London, Ontario, Canada, N6C 5J1
    • MIssissauga, Ontario, Canada, L5B 2P7
    • Mississauga, Ontario, Canada, L4T2J2
    • NewMarket, Ontario, Canada, L3Y 8C3
    • Oshawa, Ontario, Canada, L1H 1B9
    • Smiths Falls, Ontario, Canada, K7A 4W8
    • Sudbury, Ontario, Canada, P3C 5K7
    • Sudbury, Ontario, Canada, P3E 3B8
    • Sudbury, Ontario, Canada, P3E 5J1
    • Thunder Bay, Ontario, Canada, P7B 6V4
    • Toronto, Ontario, Canada, M5B 1W8
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 8T5
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
    • Chicoutimi, Quebec, Canada, G7H 7Y8
    • Gatineau, Quebec, Canada, J8Y 6S9
    • Granby, Quebec, Canada, J2G 8Z9
    • Granby, Quebec, Canada, J2G 1T7
    • Laval, Quebec, Canada, H7M 3L9
    • Longueuil, Quebec, Canada, J4M 2X1
    • Lévis, Quebec, Canada, G6V 4Z5
    • Montreal, Quebec, Canada, H4J 1C5
    • Montreal, Quebec, Canada, H1T 1C8
    • Montreal, Quebec, Canada, H3G 1A4
    • Montréal, Quebec, Canada, H2K 4L5
    • Quebec city, Quebec, Canada, G1G 3Z4
    • Quebec city, Quebec, Canada, G1N 4V3
    • Saint-Laurent, Quebec, Canada, H4T 1Z9
    • Sherbrooke, Quebec, Canada, J1H 5N4
    • Sherbrooke, Quebec, Canada, J1J 2E3
    • St-Charles-Borromée, Quebec, Canada, J6E 6J2
    • St-Lambert, Quebec, Canada, J4P 2H4
    • St-Léonard, Quebec, Canada, H1S 3A9
    • St-jerome, Quebec, Canada, J7Z 5T3
    • Ste. Foy, Quebec, Canada, G1V 4G5
    • Terrebonne, Quebec, Canada, J6V 2H2
    • Trois-Rivieres, Quebec, Canada, G8Z 3R9
    • Val DOr, Quebec, Canada, J9P 3Y1
    • Vaudreuil-Dorion, Quebec, Canada, J7V 8P9
• China
  • Baotou, China, 014040
  • Beijing, China, 100050
  • Beijing, China, 100730
  • Beijing, China, 100020
  • Beijing, China, 100029
  • Beijing, China, 100088
  • Beijing, China, 100038
  • Beijing, China, 100853
  • Beijing, China, 100101
  • Beijing, China, 10029
  • Beijng, China, 100700
  • Changsha, China, 410011
  • Changsha, China, 410013
  • Changsha, China, 410007
  • Chengdu, China, 610041
  • Dalian, China, 116011
  • Daqing, China, 163001
  • Guangzhou, China, 510080
  • Guangzhou, China, 510030
  • Hangzhou, China, 310003
  • Hangzhou, China, 310016
  • Hangzhou, China, 310013
  • Jinan, China, 250012
  • Nanjing, China, 210009
  • Nanning, China, 530021
  • Qingdao, China, 266011
  • Shanghai, China, 200233
  • Shanghai, China, 200040
  • Shanghai, China, 200001
  • Shanghai, China, 200030
  • Shanghai, China, 200065
  • Shanghai, China, 200011
  • Shanghai, China, 200072
  • Shanghai, China, 200031
  • ShenYang, China, 110004
  • Shenyang, China, 110016
  • Shijiazhuang, China, 050082
  • Tianjin, China, 300014
  • Wuhan, China, 430071
  • Xi'an, China, 710061
• Czech Republic
  • Brno, Czech Republic, 625 00
  • Brno, Czech Republic, CA-656 91
  • Hradec Kralove, Czech Republic, 50005
  • Jindrichuv Hradec, Czech Republic, 37701
  • Kladno, Czech Republic, 27259
  • Olomouc, Czech Republic, 77520
  • Prague, Czech Republic, 14021
  • Prague 2, Czech Republic, 128 00
  • Prague 2, Czech Republic, 128 08
  • Tabor, Czech Republic, 390 03
  • Teplice, Czech Republic, 41529
  • Trutnov, Czech Republic, 541 01
  • Znojmo, Czech Republic, 669 02
• Denmark
  • Aalborg, Denmark, 9000
  • Copenhagen, Denmark
  • Fredericia, Denmark, 7000
  • Herning, Denmark, 7400
  • Odense, Denmark, 5000 C
  • Slagelse, Denmark, 4200
• France
  • Albi, France, 81000
  • Besancon, France, 25000
  • Bron, France, 69677
  • Cambrai, France, 59407
  • Creteil, France, 94010
  • Dijon, France, 21079
  • Lagny-sur-marne, France, 77405
  • Le Coudray, France, 28630
  • Le Plessis Robinson, France, 92350
  • Marseille, France, 13285
  • Montfermeil, France, 93370
  • Montpellier, France, 34295
  • Paris, France, 75908
  • Paris, France, 75651
  • Pessac, France, 3600
  • St Herblain, France, 44800
  • Valenciennes, France, 59322
• Germany
  • Bad Krozingen, Germany, 79189
  • Bad Nauheim, Germany, 61231
  • Bad Oeynhausen, Germany, 32545
  • Bad Rothenfelde, Germany, 49124
  • Berlin, Germany, 13353
  • Berlin, Germany, 12203
  • Berlin, Germany, 13187
  • Berlin, Germany, 14050
  • Berlin, Germany, 12559
  • Bernried, Germany, 82347
  • Bochum, Germany, 44789
  • Bonn, Germany, 53127
  • Brandenburg, Germany, 14770
  • Burg, Germany, 03096
  • Cologne, Germany, 50923
  • Dortmund, Germany, 44137
  • Düsseldorf, Germany, 40225
  • Essen, Germany, 45122
  • Frankfurt, Germany, 65929
  • Fulda, Germany, 36043
  • Fürth, Germany, 90766
  • Halle, Germany, 06120
  • Hamburg, Germany, 20099
  • Hannover, Germany, 30167
  • Heidelberg, Germany, 69126
  • Homburg/Saar, Germany, 66424
  • Kiel, Germany, 24105
  • Lahr, Germany, 77933
  • Langen, Germany, 63225
  • Mainz, Germany, 55131
  • Mannheim, Germany, 68167
  • Muenchen, Germany, 80336
  • Mönchengladbach, Germany, 41063
  • Münster, Germany, 48149
  • Nienburg, Germany, 31582
  • Pirna, Germany, 01796
  • Regensburg, Germany, 93053
  • Rotenburg, Germany, 36199
  • Ruedersdorf, Germany, 15562
  • Wuppertal, Germany, 42117
• Grenada
  • Toulouse, Grenada, 31059
• Hungary
  • Balatonfuered, Hungary, 8230
  • Budapest, Hungary, 1115
  • Budapest, Hungary, 1088
  • Budapest, Hungary, 1085
  • Budapest, Hungary, 1097
  • Budapest, Hungary, 1032
  • Budapest, Hungary, 1096
  • Debrecen, Hungary, 4032
  • Gyula, Hungary, 5700
  • Kaposvár, Hungary, 7400
  • Kecskemet, Hungary, 6000
  • Miskolc, Hungary, 3526
  • Pécs, Hungary, 7643
  • Szolnok, Hungary, 5004
  • Szombathely, Hungary, 9700
  • Székeshehérvár, Hungary, 8000
  • Zalaegerszeg, Hungary, 8900
• India
  • Ahmedabad, India, 380015
  • Ahmedabad, India, 380005
  • Ahmedabad, India, 380014
  • Ahmedabad, India, 380051
  • Bangalore, India, 560099
  • Bangalore, India, 560038
  • Bangalore, India, 560060
  • Banglore, India, 560034
  • Belgaum, India, 590001
  • Belgaum, India, 590010
  • Chennai, India, 600100
  • Cochin, India, 682041
  • Gurgaon, India, 122001
  • Hyderabad, India, 500063
  • Hyderabad, India, 500034
  • Hyderabad, India, 500001
  • Hyderabad, India, 500004
  • Hyderabad, India, 500024
  • Indore, India, 452001
  • Jaipur, India, 302004
  • Kolkata, India, 700020
  • Lucknow, India, 226014
  • Madhurai, India, 625107
  • Mangalore, India, 575001
  • Mangalore, India, 575002
  • Mangalore, India, 575 002
  • Mumbai, India, 400012
  • Mumbai, India, 400051
  • Mysore, India, 570004
  • Nagpur, India, 440008
  • Nagpur, India, 440010
  • New Delhi, India, 110060
  • Palakkad, India, 678013
  • Pune, India, 411004
  • Pune, India, 411030
  • Pune, India, 411 001
  • Secunderabad, India, 500003
  • Trivandeum, India, 695011
  • Kerala
    • Kochi, Kerala, India, 682304
  • Maharashtra
    • Pune, Maharashtra, India, 411011
• Ireland
  • Ballinasloe, Ireland
  • Dublin, Ireland, 9
  • Dublin, Ireland, 7
  • Dublin, Ireland, 8
  • Galway, Ireland
  • Tallaght Dublin, Ireland, D24
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
    • Pozzuoli, Campania, Italy, 80078
  • Emilia-Romagna
    • Bentivoglio, Emilia-Romagna, Italy, 40010
    • Ferrara, Emilia-Romagna, Italy, 44100
    • Reggio Emilia, Emilia-Romagna, Italy, 42123
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
  • Lazio
    • Rome, Lazio, Italy, 00189
  • Lombardia
    • Bergamo, Lombardia, Italy, 24128
    • Legnano, Lombardia, Italy, 20025
    • Mantova, Lombardia, Italy, 46100
    • Milano, Lombardia, Italy, 20162
    • Milano, Lombardia, Italy, 20138
    • Pavia, Lombardia, Italy, 27100
  • Umbria
    • Perugia, Umbria, Italy, 06100
  • Veneto
    • Cittadella, Veneto, Italy, 35013
    • Rovigo, Veneto, Italy, 45100
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
  • Busan, Korea, Republic of, 47392
  • Busan, Korea, Republic of, 49267
  • Daegu, Korea, Republic of, 41931
  • Daegu, Korea, Republic of, 705-717
  • Daejeon, Korea, Republic of, 35015
  • Gwangju, Korea, Republic of, 61469
  • Gyeonggi-Do, Korea, Republic of, 431-070
  • Gyeonggi-do, Korea, Republic of, 443-380
  • Gyeonggi-do, Korea, Republic of, 10380
  • Gyeonggi-do, Korea, Republic of, 14647
  • Incheon, Korea, Republic of, 405-760
  • Incheon, Korea, Republic of, 400-711
  • Jeollabuk-do, Korea, Republic of, 561-712
  • Kyonggi-do, Korea, Republic of, 411-719
  • Seoul, Korea, Republic of, 130-702
  • Seoul, Korea, Republic of, 03080
  • Seoul, Korea, Republic of, 136-705
  • Seoul, Korea, Republic of, 150-950
  • Seoul, Korea, Republic of, 156-707
  • Seoul, Korea, Republic of, 152-703
  • Seoul, Korea, Republic of, 06973
  • Seoul, Korea, Republic of, 140-743
  • Suwon, Korea, Republic of, 442-723
  • Uijongbu, Korea, Republic of, 480-130
  • Ulsan, Korea, Republic of, 44033
  • Wonju, Korea, Republic of, 220-701
• Malaysia
  • Kelantan, Malaysia, 16150
  • Kota Bharu, Malaysia, 15586
  • Kuala Lumpur, Malaysia, 59100
  • Kuala Lumpur, Malaysia, 50400
  • Kuantan, Malaysia, 25100
  • Penang, Malaysia, 10990
  • Sarawak, Malaysia, 93586
  • Serdang, Malaysia, 43000
• Mexico
  • Acapulco, Mexico, 39670
  • Aguascalientes, Mexico, 20230
  • Aguascalientes, Mexico, 20127
  • Chihuahua, Mexico, 31000
  • Chihuahua, Mexico, 31217
  • Ciudad Juárez, Mexico, 32420
  • Cuernavaca, Mexico, 62250
  • Culiacan, Mexico, 80020
  • Durango, Mexico, 34000
  • Durango, Mexico, 34080
  • Guadalajara, Mexico, 44650
  • Guadalajara, Mexico, 44600
  • Guadalajara, Mexico, 44210
  • Mexico City, Mexico, 14000
  • Mexico City, Mexico, 14080
  • Mexico City, Mexico, 14050
  • Mexico City, Mexico, 11650
  • Mexico City, Mexico, 10700
  • Monterrey, Mexico, 64460
  • Monterrey, Mexico, 64060
  • Monterrey, Mexico, 64710
  • Monterrey, Mexico, 64640
  • Pachuca, Mexico, 42000
  • Puebla, Mexico, 72490
  • Puerto Vallarta, Mexico, 48328
  • Queretaro, Mexico, 76000
  • San Luis Potosi S.L.P., Mexico, 78240
  • Tampico, Mexico, 89000
  • Tijuana, Mexico, 22010
  • Tlalnepantla, Mexico, 54055
  • Veracruz, Mexico, 91700
  • Xalapa, Mexico, 91020
  • Zapopan, Mexico, 45200
• Netherlands
  • AC Amsterdam, Netherlands, 1091
  • Amstelveen, Netherlands, 1186 AH
  • Amsterdam, Netherlands, 1105 AZ
  • Amsterdam, Netherlands, 1066 EC
  • Hoorn, Netherlands, 1625 HV
  • Leiden, Netherlands, 2333 ZA
  • Maastricht, Netherlands, 6202 AZ
  • Nieuwegein, Netherlands, 3435 CM
  • Nijmegen, Netherlands, 6500 HB
  • Purmerend, Netherlands, 1441 RN
  • Tilburg, Netherlands, 5042 AD
  • Weert, Netherlands, 6001 BE
  • Zaandam, Netherlands, 1502 DV
  • Zwolle, Netherlands, 8011 JW
• New Zealand
  • Auckland, New Zealand
  • Christchurch, New Zealand, 8140
  • Hamiton, New Zealand, 3240
  • Lower Hutt, New Zealand, 5040
  • Nelson, New Zealand, 7001
  • Palmerston North, New Zealand, 4410
  • Tauranga, New Zealand, 3112
• Poland
  • Bialystok, Poland, 15-276
  • Bielsko-Biala, Poland, 43-316
  • Bydgoszcz, Poland, 85-826
  • Bydgoszcz, Poland, 85-863
  • Bytom, Poland, 41-902
  • Bêdzin, Poland, 42-500
  • Cracow, Poland, 30-092
  • Gdansk, Poland, 80-952
  • Gdansk, Poland, 80-126
  • Gdynia, Poland, 81-519
  • Gdynia, Poland, 81-472
  • Gdynia, Poland, 81-402
  • Gdynia, Poland, 81-423
  • Gorlice, Poland, 38-300
  • Grodzisk Mazowiecki, Poland, 05-754
  • Katowice, Poland, 40-005
  • Kedzierzyn-Kozle, Poland, 47-200
  • Kielce, Poland, 25-315
  • Krakow, Poland, 31-202
  • Krakow, Poland, 30-082
  • Krakow, Poland, 31-351
  • Kutno, Poland, 99-300
  • Libiaz, Poland, 32-590
  • Lodz, Poland, 91-302
  • Lodz, Poland, 91-490
  • Lublin, Poland, 20-059
  • Lublin, Poland, 20-834
  • Nowa Sol, Poland, 67-100
  • Nysa, Poland, 48-303
  • Olawa, Poland, 55-200
  • Olesnica, Spalice, Poland, 56-400
  • Olsztyn, Poland, 10-561
  • Poznan, Poland, 61-848
  • Pulawy, Poland, 24-100
  • Radom, Poland, 26-600
  • Rzeszow, Poland, 35301
  • Swidnica, Poland, 58-100
  • Tarnow, Poland, 33-100
  • Tarnów, Poland, 33-100
  • Torun, Poland, 87-100
  • Ustron, Poland, 43-450
  • Ustroñ, Poland, 43-450
  • Warsaw, Poland, 02-097
  • Warsaw, Poland, 02-637
  • Warszawa, Poland, 02-097
  • Warszawa, Poland, 03-242
  • Warszawa, Poland, 04-141
  • Warszawa, Poland, 03-599
  • Wola, Poland, 43-225
  • Wroclaw, Poland, 50-981
  • Zamosc, Poland, 22-400
  • Zarow, Poland, 58-130
  • Zgorzelec, Poland, 59-900
  • £ódx, Poland, 91-347
• Romania
  • Brasov, Romania, 500360
  • Bucharest, Romania, 010628
  • Bucharest, Romania, 020992
  • Buzau, Romania, 120203
  • Cluj-Napoca, Romania, 400006
  • Craiova, Romania, 200147
  • Galati, Romania, 800371
  • Oradea, Romania, 410169
  • Ploiesti, Romania, 100163
  • Targu-Mures, Romania, 540124
  • Timisoara, Romania, 300310
• Russian Federation
  • Moscow, Russian Federation, 111539
  • Saint-Petersburg, Russian Federation, 193312
  • Saint-Petersburg, Russian Federation, 194291
  • Saint-Petersburg, Russian Federation, 197341
• Spain
  • Alicante, Spain, 03010
  • Almeria, Spain, 04009
  • Barcelona, Spain, 08003
  • Barcelona, Spain, 08035
  • Barcelona, Spain, 08025
  • Guadalajara, Spain, 19002
  • Lugo, Spain, 27004
  • Madrid, Spain, 28040
  • Madrid, Spain, 28041
  • Madrid, Spain, 28007
  • Malaga, Spain, 29010
  • Murcia, Spain, 30008
  • Salamanca, Spain, 37007
  • Tarragona, Spain, 43007
  • Valencia, Spain, 46017
  • Valencia, Spain, 46014
  • Alava
    • Vitoria, Alava, Spain, 01009
  • Alicante
    • Torrevieja, Alicante, Spain, 03186
  • Asturias
    • Oviedo, Asturias, Spain, 33006
  • Barcelona
    • Granollers, Barcelona, Spain, 08400
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Sabadell, Barcelona, Spain, 08208
    • Terrassa, Barcelona, Spain, 08227
  • Cadiz
    • Jerez de La Frontera, Cadiz, Spain, 11402
  • Girona
    • Figueres, Girona, Spain, 17600
  • La Coruña
    • Coruna, La Coruña, Spain, 15006
    • Ferrol, La Coruña, Spain, 15405
    • Santiago de Compostela, La Coruña, Spain, 15706
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
    • San Sebastian de los Reyes, Madrid, Spain, 28702
  • Sevilla
    • Seville, Sevilla, Spain, 41071
  • Tarragona
    • Reus, Tarragona, Spain, 43201
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
• Sweden
  • Danderyd Stockholm, Sweden, SE-182 88
  • Goteborg, Sweden, 413 45
  • Halmstad, Sweden, 301 85
  • Kalmar, Sweden, 391 85
  • Karlstad, Sweden, 65185
  • Kristianstad, Sweden, 29185
  • Malmö, Sweden, 20502
  • Ostersund, Sweden, 83 183
  • Skellefteå, Sweden, 0910-77
  • Skovde, Sweden, 541 85
  • Stockholm, Sweden, 17176
  • Stockholm, Sweden, 11883
• Thailand
  • Amphur Mae-Rim, Thailand, 50180
  • Amphur Muang, Thailand, 57000
  • Amphur Muang, Thailand, 65000
  • Bangkok, Thailand, 10400
  • Bangkok, Thailand, 10700
  • Bangkok, Thailand, 10330
  • Bangkok, Thailand, 10300
  • ChiangMai, Thailand, 50200
  • Chonburi, Thailand, 20000
  • Khon Kaen, Thailand, 40002
  • Khonkaen, Thailand, 40000
  • Klong Luang, Thailand, 12120
  • Phitsanulok, Thailand, 65000
  • Saraburi, Thailand, 18000
• United Kingdom
  • AYR, United Kingdom, KA6 6DX
  • Abano Terme, United Kingdom, 35031
  • Antrim, United Kingdom, BT41 2RL
  • Basildon, United Kingdom, SS16 5NL
  • Bath, United Kingdom, BA1 3NG
  • Belfast, United Kingdom, BT47 6SB
  • Belfast, United Kingdom, BT13 3BW
  • Brighton, United Kingdom, BN2 1ES
  • Cambridge, United Kingdom, CB2 0QQ
  • Craigavon, United Kingdom, BT63 5QQ
  • Derby, United Kingdom, DE22 3DT
  • Glasgow, United Kingdom, G11 6NK
  • Harrow, United Kingdom, HA1 3UJ
  • Inverness, United Kingdom, IV2 4RE
  • Isle of Wight, United Kingdom, 30 5TG.
  • Isleworth, United Kingdom, TW7 6AF
  • Leeds, United Kingdom
  • London, United Kingdom, E1 2AT
  • Manchester, United Kingdom, M13 9WL
  • Middlesex, United Kingdom, UB1 3HW
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
  • Northampton, United Kingdom, NN1 5BD
  • Paddington, United Kingdom, W2 1LA
  • Plymouth, United Kingdom, PL6 8BX
  • Poole, United Kingdom, BH15 2JB
  • Romford, United Kingdom, RM7 0AG
  • Stoker on Trent, United Kingdom, ST4 6QG
  • West Bromwich, United Kingdom, B71 4HJ
  • Wrexham, United Kingdom, LL137TD
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
    • Birmingham, Alabama, United States, 35209
    • Mobile, Alabama, United States, 36617
    • Mobile, Alabama, United States, 36693
  • Arizona
    • Mesa, Arizona, United States, 85206
    • Phoenix, Arizona, United States, 85023
    • Phoenix, Arizona, United States, 85029
    • Tucson, Arizona, United States, 85712
    • Tucson, Arizona, United States, 85724-5078
  • California
    • Anaheim, California, United States, 92801
    • Banning, California, United States, 92220
    • Carmichael, California, United States, 95608
    • Fresno, California, United States, 93720
    • Fullerton, California, United States, 92835
    • Glendale, California, United States, 91204
    • Hawaiian Gardens, California, United States, 90716
    • Inglewood, California, United States, 90301
    • Laguna Hills, California, United States, 92653
    • Long Beach, California, United States, 90822
    • Los Angeles, California, United States, 90033
    • Northridge, California, United States, 91325
    • Orange, California, United States, 92868
    • Pomona, California, United States, 91767
    • Redondo Beach, California, United States, 90277
    • Salinas, California, United States, 93901
    • San Diego, California, United States, 92103
    • San Francisco, California, United States, 94115
    • Santa Ana, California, United States, 92704
    • Sylmar, California, United States, 91342
    • Thousand Oaks, California, United States, 91360
    • Torrance, California, United States, 90502
    • Ventura, California, United States, 90265
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
    • Denver, Colorado, United States, 80218
    • Denver, Colorado, United States, 80220
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
    • Hartford, Connecticut, United States, 06102
    • Stamford, Connecticut, United States, 06905
  • Delaware
    • Seaford, Delaware, United States, 19973
  • Florida
    • Aventura, Florida, United States, 33180
    • Boynton Beach, Florida, United States, 33472
    • Clearwater, Florida, United States, 33756
    • Coral Springs, Florida, United States, 33065
    • Doral, Florida, United States, 33166
    • Edgewater, Florida, United States, 32141
    • Elizabeth, Florida, United States, 07202
    • Ft. Lauderdale, Florida, United States, 33316
    • Gainesville, Florida, United States, 32608
    • Hialeah, Florida, United States, 33010
    • Hollywood, Florida, United States, 33021
    • Jacksonville Beach, Florida, United States, 32250
    • Melbourne, Florida, United States, 32901
    • Miami, Florida, United States, 33173
    • Miami, Florida, United States, 33136
    • Miramar, Florida, United States, 33025
    • Naples, Florida, United States, 34102
    • Ocala, Florida, United States, 34471
    • Orlando, Florida, United States, 32806
    • Panama City, Florida, United States, 32401
    • Sarasota, Florida, United States, 34239
    • Sarasota, Florida, United States, 34292
    • St. Petersburg, Florida, United States, 33709
    • St. Petersburg, Florida, United States, 33701
    • Tampa, Florida, United States, 33613
    • Trinity, Florida, United States, 34652
    • Vero Beach, Florida, United States, 32960
  • Georgia
    • Atlanta, Georgia, United States, 30312
    • Decatur, Georgia, United States, 30033
    • Macon, Georgia, United States, 31201
  • Illinois
    • Gurnee, Illinois, United States, 60031
  • Indiana
    • Elkhart, Indiana, United States, 46514
    • Indianapolis, Indiana, United States, 46260
    • Lafayette, Indiana, United States, 47905
  • Iowa
    • Ames, Iowa, United States, 50010
    • Council Bluffs, Iowa, United States, 51501
    • Davenport, Iowa, United States, 52803
    • Des Moines, Iowa, United States, 50314
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
    • Owensboro, Kentucky, United States, 42303
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
    • Convington, Louisiana, United States, 70433
    • Hammond, Louisiana, United States, 70403
    • Houma, Louisiana, United States, 70360
    • LaPlace, Louisiana, United States, 70068
    • Lafayette, Louisiana, United States, 70508
    • Metarie, Louisiana, United States, 70002
    • New Orleans, Louisiana, United States, 70112
    • New Orleans, Louisiana, United States, 70121
    • Opelousas, Louisiana, United States, 70570
    • Shreveport, Louisiana, United States, 71101
    • Shreveport, Louisiana, United States, 71105
    • Slidell, Louisiana, United States, 70458
    • Zachary, Louisiana, United States, 70791
  • Maine
    • Bangor, Maine, United States, 04401
  • Maryland
    • Annapolis, Maryland, United States, 21401
    • Baltimore, Maryland, United States, 21201
    • Baltimore, Maryland, United States, 21236
    • Columbia, Maryland, United States, 21044
    • Oxon Hill, Maryland, United States, 20745
    • Salisbury, Maryland, United States, 21801
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
    • Boston, Massachusetts, United States, 02114
    • Fall River, Massachusetts, United States, 02720
    • Hyannis, Massachusetts, United States, 02601
    • Worcester, Massachusetts, United States, 01604
  • Michigan
    • Alpena, Michigan, United States, 49707
    • Ann Arbor, Michigan, United States, 48106
    • Bay City, Michigan, United States, 48708
    • Flint, Michigan, United States, 48423
    • Kalamazoo, Michigan, United States, 49048
    • Lansing, Michigan, United States, 48910
    • Petoskey, Michigan, United States, 49770
    • Royal Oak, Michigan, United States, 48073
    • Saginaw, Michigan, United States, 48602
    • Saginaw, Michigan, United States, 48604
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
    • Minneapolis, Minnesota, United States, 55415
    • Minneapolis, Minnesota, United States, 55407
    • Rochester, Minnesota, United States, 55905
    • Saint Paul, Minnesota, United States, 55102
    • St. Cloud, Minnesota, United States, 56362
  • Mississippi
    • Jackson, Mississippi, United States, 39216
    • Picayune, Mississippi, United States, 39466
  • Missouri
    • Chesterfield, Missouri, United States, 63017
    • Washington, Missouri, United States, 63090
  • Montana
    • Great Falls, Montana, United States, 59405
  • Nebraska
    • Freemont, Nebraska, United States, 68025
    • Omaha, Nebraska, United States, 68114
    • Omaha, Nebraska, United States, 68131
  • Nevada
    • Las Vegas, Nevada, United States, 89102
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
    • Mine Hill, New Jersey, United States, 07803
    • Newark, New Jersey, United States, 07103
    • Somerset, New Jersey, United States, 08873
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
    • Albuquerque, New Mexico, United States, 87131
  • New York
    • Albany, New York, United States, 12211
    • Albany, New York, United States, 12206-1098
    • Bronx, New York, United States, 10469
    • Brooklyn, New York, United States, 11215
    • Buffalo, New York, United States, 14215
    • New York, New York, United States, 10032
    • New York, New York, United States, 10021
    • New York, New York, United States, 10025
    • New York, New York, United States, 10029
    • Suffern, New York, United States, 10901
    • Syracuse, New York, United States, 13210
    • Troy, New York, United States, 12180
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
    • Durham, North Carolina, United States, 27710
    • Durham, North Carolina, United States, 27704
    • Greenville, North Carolina, United States, 27834
    • Rocky Mount, North Carolina, United States, 27804
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Canton, Ohio, United States, 44708
    • Cincinnati, Ohio, United States, 45219
    • Cincinnati, Ohio, United States, 45224
    • Cleveland, Ohio, United States, 44106
    • Columbus, Ohio, United States, 43221
    • Columbus, Ohio, United States, 43201
    • Dayton, Ohio, United States, 45428
    • Kettering, Ohio, United States, 45429
    • Marion, Ohio, United States, 43302
    • Middleburg Heights, Ohio, United States, 44130
    • Springfield, Ohio, United States, 45505
    • Toledo, Ohio, United States, 43608
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
    • Tulsa, Oklahoma, United States, 74104
  • Oregon
    • Portland, Oregon, United States, 97239
  • Pennsylvania
    • Chambersburg, Pennsylvania, United States, 17201
    • Danville, Pennsylvania, United States, 17822
    • Harrisburg, Pennsylvania, United States, 17112
    • Natrona Heights, Pennsylvania, United States, 15065
    • Philadelphia, Pennsylvania, United States, 19107
    • Philadelphia, Pennsylvania, United States, 19140
    • Philadelphia, Pennsylvania, United States, 19106
    • Pottstown, Pennsylvania, United States, 19464
    • Upper Darby, Pennsylvania, United States, 19082
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
    • Providence, Rhode Island, United States, 02906
    • Providence, Rhode Island, United States, 02903
  • South Carolina
    • Greer, South Carolina, United States, 29651
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
    • Kingsport, Tennessee, United States, 37660
    • Lexington, Tennessee, United States, 38351
    • Nashville, Tennessee, United States, 37203
    • Tullahoma, Tennessee, United States, 37388
  • Texas
    • Amarillo, Texas, United States, 79106
    • Austin, Texas, United States, 78705
    • Bellaire, Texas, United States, 77401
    • Dallas, Texas, United States, 75216
    • Dallas, Texas, United States, 75231
    • Dallas, Texas, United States, 75230
    • Dallas, Texas, United States, 75390-9063
    • Grapevine, Texas, United States, 76051
    • Houston, Texas, United States, 77030
    • Houston, Texas, United States, 77024
    • Houston, Texas, United States, 77090
    • Houston, Texas, United States, 77002
    • Houston, Texas, United States, 77075
    • Kerrville, Texas, United States, 78028
    • Kingwood, Texas, United States, 77339
    • Lubbock, Texas, United States, 79410
    • Odessa, Texas, United States, 79761
    • Plano, Texas, United States, 75024
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78258
    • San Antonio, Texas, United States, 78205
    • Tomball, Texas, United States, 77375
    • Victoria, Texas, United States, 77901
  • Utah
    • Layton, Utah, United States, 84041
    • Murray, Utah, United States, 84157
  • Virginia
    • Danville, Virginia, United States, 24541
    • Roanoke, Virginia, United States, 24104
  • West Virginia
    • Huntington, West Virginia, United States, 25701
  • Wisconsin
    • Beloit, Wisconsin, United States, 53511
    • Burlington, Wisconsin, United States, 53105
    • Green Bay, Wisconsin, United States, 54301
    • LaCrosse, Wisconsin, United States, 54601-4795
    • Milwaukee, Wisconsin, United States, 53215
    • Milwaukee, Wisconsin, United States, 53295

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults >18 years of age
• Type 2 diabetes mellitus
• Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)

Exclusion Criteria:

• Estimated glomerular filtration rate <45 mL/min/1.73m2
• Concomitant treatment with a thiazolidinedione and/or fibrate
• Triglycerides >400 mg/dL
• Anaemia
• Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; placebo control po daily
EXPERIMENTAL: Aleglitazar	Drug: Aleglitazar; aleglitazar 150 micrograms po daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke	Throughout study, approximately 4.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Effects on other cardiovascular endpoints	Throughout study, approximately 4.5 years
Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk	Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter
Tolerability and long-term safety profile	Throughout study, approximately 4.5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Schrieks IC, Nozza A, Stahli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Ryden L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.
• Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Ryden L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.
• Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Ryden L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor alpha/gamma agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 5, 2010
• First Posted (ESTIMATE): January 6, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Acute Coronary Syndrome
• Other Study ID Numbers: BC22140; 2009-012269-71