Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.

This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Exenatide Once Weekly; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 14752
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425AGC
    • Research Site
  • Buenos Aires, Argentina, C1437BZL
    • Research Site
  • Caba, Argentina, 1426
    • Research Site
  • Caba, Argentina, C1119ACN
    • Research Site
  • Caba, Argentina, C1120AAC
    • Research Site
  • Capital Federal, Argentina, C1425DES
    • Research Site
  • CiudadAutonoma De Buenos Aires, Argentina, C1419AHL
    • Research Site
  • Cordoba, Argentina, 5000
    • Research Site
  • Cordoba, Argentina, X5003DCE
    • Research Site
  • Cordoba, Argentina, X5008HHW
    • Research Site
  • Cordoba, Argentina, X5004FHP
    • Research Site
  • Godoy Cruz, Argentina, M5501ARP
    • Research Site
  • Jujuy, Argentina
    • Research Site
  • Mar Del Plata Buenos Aires, Argentina, B7600DIA
    • Research Site
  • Rosario, Argentina, S2000CVD
    • Research Site
  • Salta, Argentina, A4400ANG
    • Research Site
  • San Miguel de Tucuman, Argentina, 4000
    • Research Site
  • Santa Rosa, Argentina
    • Research Site
• Australia
  • Adelaide, Australia, 5000
    • Research Site
  • Camperdown, Australia, 2050
    • Research Site
  • Clayton, Australia, 3168
    • Research Site
  • East Gosford, Australia, 2250
    • Research Site
  • Elizabeth Vale, Australia, 5112
    • Research Site
  • Fitzroy, Australia, 3065
    • Research Site
  • Garran, Australia, 2605
    • Research Site
  • Geelong, Australia, 3220
    • Research Site
  • Heidelberg West, Australia, 3081
    • Research Site
  • Meadobank, Australia, 4131
    • Research Site
  • Milton, Australia, 4064
    • Research Site
  • Parkville, Australia, 3050
    • Research Site
  • Sydney, Australia, 2006
    • Research Site
• Austria
  • Feldkirch, Austria, 6807
    • Research Site
  • Graz, Austria, 8036
    • Research Site
  • Innsbruck, Austria, 6020
    • Research Site
  • Salzburg, Austria, 5020
    • Research Site
  • Wien, Austria, 1130
    • Research Site
  • Wien, Austria, 1090
    • Research Site
  • Wien, Austria, 1160
    • Research Site
  • Wien, Austria, 1030
    • Research Site
  • Zams, Austria, 6511
    • Research Site
• Belgium
  • Bruxelles, Belgium, 1200
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Merksem, Belgium, 2170
    • Research Site
  • Ronse, Belgium, 9600
    • Research Site
• Brazil
  • Aparecida de Goiânia, Brazil, 74905-350
    • Research Site
  • Belém, Brazil, 66073-000
    • Research Site
  • Brasilia, Brazil, 71625-175
    • Research Site
  • Campinas, Brazil, 13060-904
    • Research Site
  • Campinas, Brazil, 13010-001
    • Research Site
  • Curitiba, Brazil, 80060-900
    • Research Site
  • Curitiba, Brazil, 80730-150
    • Research Site
  • Fortaleza, Brazil, 60115282
    • Research Site
  • Fortaleza, Brazil, 60430-350
    • Research Site
  • Goiânia, Brazil, 74125-170
    • Research Site
  • Marília, Brazil, 17515-460
    • Research Site
  • Passo Fundo, Brazil, 99010-080
    • Research Site
  • Recife, Brazil, 52020010
    • Research Site
  • Sao Paulo, Brazil, 04022001
    • Research Site
  • São Paulo, Brazil, 01244-030
    • Research Site
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Research Site
  • Gabrovo, Bulgaria, 5300
    • Research Site
  • Gulyantsi, Bulgaria, 5960
    • Research Site
  • Plovdiv, Bulgaria, 4000
    • Research Site
  • Plovdiv, Bulgaria, 4002
    • Research Site
  • Sevlievo, Bulgaria, 5400
    • Research Site
  • Sliven, Bulgaria, 8800
    • Research Site
  • Sofia, Bulgaria
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Sofia, Bulgaria, 1233
    • Research Site
  • Sofia, Bulgaria, 1606
    • Research Site
  • Sofia, Bulgaria, 1632
    • Research Site
  • Stara Zagora, Bulgaria, 6000
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • Research Site
  • British Columbia
    • Delta, British Columbia, Canada, V4K 2K5
      • Research Site
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Research Site
    • Surrey, British Columbia, Canada, V3V 0C6
      • Research Site
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Research Site
    • Winnipeg, Manitoba, Canada, R2H 0R8
      • Research Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Research Site
  • Nova Scotia
    • Bridgewater, Nova Scotia, Canada, B4V 3N2
      • Research Site
    • Liverpool, Nova Scotia, Canada, B0T 1K0
      • Research Site
  • Ontario
    • Cambridge, Ontario, Canada, N1R 6V6
      • Research Site
    • Guelph, Ontario, Canada, N1H 1B1
      • Research Site
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Research Site
    • Hamilton, Ontario, Canada, L8L 5G8
      • Research Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • Research Site
    • Kitchener, Ontario, Canada, N2M 5N6
      • Research Site
    • London, Ontario, Canada, N6B 2E5
      • Research Site
    • North York, Ontario, Canada, M3M 3E5
      • Research Site
    • Ottawa, Ontario, Canada, K1H 1A2
      • Research Site
    • Scarborough, Ontario, Canada, M1E 5E9
      • Research Site
    • Smiths Falls, Ontario, Canada, K7A 4W8
      • Research Site
    • Toronto, Ontario, Canada, M5C 2T2
      • Research Site
    • Toronto, Ontario, Canada, M5T 3L9
      • Research Site
  • Quebec
    • Laval, Quebec, Canada, H7T 2P5
      • Research Site
    • Montreal, Quebec, Canada, H1M 1B1
      • Research Site
    • Montreal, Quebec, Canada, H3A 1A1
      • Research Site
    • Sainte Foy, Quebec, Canada, G1V 4G5
      • Research Site
    • Terrebonne, Quebec, Canada, J6V 1S8
      • Research Site
• Chile
  • Osorno, Chile, 5290000
    • Research Site
  • Puerto Varas, Chile
    • Research Site
  • Santiago, Chile, 7500710
    • Research Site
  • Santiago, Chile, 8053095
    • Research Site
  • Temuco, Chile, 4781173
    • Research Site
  • Vina del Mar, Chile, 2570017
    • Research Site
• China
  • Beijing, China, 100853
    • Research Site
  • Beijing, China, 100034
    • Research Site
  • Beijing, China, 100029
    • Research Site
  • Beijing, China, 100044
    • Research Site
  • Chongqing, China, 400010
    • Research Site
  • Chongqing, China, 400016
    • Research Site
  • Chuangchun, China, 130012
    • Research Site
  • Guangzhou, China, 510120
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Hangzhou, China, 310009
    • Research Site
  • Hong Kong, China
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Nanjing, China, 210012
    • Research Site
  • Nanning, China, 530021
    • Research Site
  • Shanghai, China, 200072
    • Research Site
  • Shijiazhuang, China, 050000
    • Research Site
  • Siping, China, 136000
    • Research Site
  • Suzhou, China, 215004
    • Research Site
  • Wenzhou, China
    • Research Site
  • Wuhan, China, 430000
    • Research Site
  • Xian, China, 710061
    • Research Site
  • Yinchuan, China, 750004
    • Research Site
• Colombia
  • Barranquilla, Colombia
    • Research Site
  • Barranquilla, Colombia, 80020
    • Research Site
  • Bogotá, Colombia
    • Research Site
  • Bogotá D.C., Colombia
    • Research Site
  • Cali, Colombia, 760035
    • Research Site
  • Manizales, Colombia, 17001
    • Research Site
  • Medellin, Colombia, 5001000
    • Research Site
  • Medellín, Colombia
    • Research Site
• Czechia
  • Olomouc-Lazce, Czechia, 779 00
    • Research Site
  • Praha 10, Prague, Czechia, 100 34
    • Research Site
  • Praha 4, Czechia, 140 00
    • Research Site
  • Svitavy, Czechia, 568 25
    • Research Site
  • Znojmo, Czechia, 669 02
    • Research Site
• Germany
  • Aachen, Germany, 52074
    • Research Site
  • Aschaffenburg, Germany, 63739
    • Research Site
  • Bad Nauheim, Germany, 61231
    • Research Site
  • Bad Oeynhausen, Germany, 32545
    • Research Site
  • Berlin, Germany, 13125
    • Research Site
  • Berlin, Germany, 10787
    • Research Site
  • Berlin, Germany, 13353
    • Research Site
  • Bochum, Germany, 44791
    • Research Site
  • Burg, Germany, 03096
    • Research Site
  • Burghausen, Germany, 84489
    • Research Site
  • Chemnitz, Germany, 09111
    • Research Site
  • Dortmund, Germany, 44137
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Dresden, Germany, 01067
    • Research Site
  • Dresden, Germany, 01219
    • Research Site
  • Eschweiler, Germany, 52249
    • Research Site
  • Essen, Germany, 45355
    • Research Site
  • Gießen, Germany, 35392
    • Research Site
  • Herne, Germany, 44653
    • Research Site
  • Hohenmölsen, Germany, 06679
    • Research Site
  • Kassel, Germany, 34121
    • Research Site
  • Kiel-Kronshagen, Germany, 24119
    • Research Site
  • Köthen, Germany, 06366
    • Research Site
  • Lichtenfels, Germany, 96215
    • Research Site
  • Mainz, Germany, 55116
    • Research Site
  • Mayen, Germany, 56727
    • Research Site
  • München, Germany, 80336
    • Research Site
  • München, Germany, 81925
    • Research Site
  • Münster, Germany, 48145
    • Research Site
  • Obermichelbach, Germany, 90587
    • Research Site
  • Osnabrueck, Germany, 49080
    • Research Site
  • Riesa, Germany, 01587
    • Research Site
  • Rotenburg, Germany, 36199
    • Research Site
  • Stuttgart, Germany, 70376
    • Research Site
  • Würzburg, Germany, 97072
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
  • Shatin, Hong Kong
    • Research Site
• Hungary
  • Balatonfüred, Hungary, 8230
    • Research Site
  • Budapest, Hungary, 1083
    • Research Site
  • Budapest, Hungary, 1085
    • Research Site
  • Budapest, Hungary, 1145
    • Research Site
  • Budapest, Hungary, 1096
    • Research Site
  • Budapest, Hungary, 1204
    • Research Site
  • Budapest, Hungary, 1213
    • Research Site
  • Budapest, Hungary, 1036
    • Research Site
  • Budapest, Hungary, 1045
    • Research Site
  • Budapest, Hungary, H-1096
    • Research Site
  • Csongrad, Hungary, 6640
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Eger, Hungary, 3300
    • Research Site
  • Gyor, Hungary, 9023
    • Research Site
  • Hodmezovasarhely, Hungary, 6800
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  • Jászberény, Hungary, 5100
    • Research Site
  • Kaposvár, Hungary, 7400
    • Research Site
  • Kecskemét, Hungary, 6000
    • Research Site
  • Komarom, Hungary, 2921
    • Research Site
  • Mosonmagyarovar, Hungary, H-9200
    • Research Site
  • Nagykanizsa, Hungary, 8800
    • Research Site
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Pápa, Hungary, 8500
    • Research Site
  • Pécs, Hungary, 7624
    • Research Site
  • Szekszárd, Hungary, 7100
    • Research Site
  • Szentes, Hungary, 6600
    • Research Site
  • Szentes, Hungary, H-6600
    • Research Site
  • Szigetvár, Hungary, 7900
    • Research Site
  • Szikszo, Hungary, 3800
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
  • Sátoraljaújhely, Hungary, 3980
    • Research Site
  • Veszprem, Hungary, 8200
    • Research Site
  • Zalaegerszeg, Hungary, 8900
    • Research Site
• Israel
  • Givatayim, Israel, 53583
    • Research Site
  • Hadera, Israel, 38100
    • Research Site
  • Hadera, Israel, 3842207
    • Research Site
  • Haifa, Israel, 34362
    • Research Site
  • Haifa, Israel, 31048
    • Research Site
  • Holon, Israel, 58100
    • Research Site
  • Jerusalem, Israel, 91120
    • Research Site
  • Jerusalem, Israel, 9103102
    • Research Site
  • Kfar Saba, Israel, 49281
    • Research Site
  • Nahariya, Israel, 22100
    • Research Site
  • Nazareth, Israel, 16100
    • Research Site
  • Petah Tikva, Israel, 49100
    • Research Site
  • Safed, Israel, 13100
    • Research Site
  • Tel-Aviv, Israel, 64239
    • Research Site
  • Tel-Aviv, Israel, 62038
    • Research Site
• Italy
  • Firenze, Italy, 50134
    • Research Site
  • Foggia, Italy, 71100
    • Research Site
  • Milano, Italy, 20138
    • Research Site
  • Pisa, Italy, 56100
    • Research Site
  • Roma, Italy, 00128
    • Research Site
  • Sesto San Giovanni, Italy, 20099
    • Research Site
  • Terni, Italy, 05100
    • Research Site
  • Udine, Italy, 33100
    • Research Site
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Research Site
  • Daegu, Korea, Republic of, 41931
    • Research Site
  • Daegu, Korea, Republic of, 700-721
    • Research Site
  • Daegu, Korea, Republic of, 705-718
    • Research Site
  • Gwangjin-gu, Korea, Republic of, 110-744
    • Research Site
  • Gyeonggi-do, Korea, Republic of, 411-706
    • Research Site
  • Incheon, Korea, Republic of, 403-720
    • Research Site
  • Seongnam, Korea, Republic of, 463-707
    • Research Site
  • Seoul, Korea, Republic of, 08308
    • Research Site
  • Seoul, Korea, Republic of, 137-701
    • Research Site
  • Seoul, Korea, Republic of, 134-727
    • Research Site
  • Seoul, Korea, Republic of, 135-720
    • Research Site
  • Seoul, Korea, Republic of, 110746
    • Research Site
  • Suwon, Korea, Republic of, 443-721
    • Research Site
  • Suwon-si, Korea, Republic of, 16247
    • Research Site
  • Ulsan, Korea, Republic of, 682-714
    • Research Site
• Latvia
  • Daugavpils, Latvia, 5417
    • Research Site
  • Jelgava, Latvia, LV-3000
    • Research Site
  • Kuldiga, Latvia, LV-3301
    • Research Site
  • Kuldiga, Latvia, LV3301
    • Research Site
  • Ogre, Latvia, LV-5001
    • Research Site
  • Riga, Latvia, LV-1002
    • Research Site
  • Riga, Latvia, 1012
    • Research Site
  • Riga, Latvia, LV1002
    • Research Site
  • Riga, Latvia, LV-1050
    • Research Site
  • Talsi, Latvia, LV-3201
    • Research Site
  • Tukums, Latvia, LV3101
    • Research Site
• Lithuania
  • Kaunas, Lithuania, 50009
    • Research Site
  • Kaunas, Lithuania, 48259
    • Research Site
  • Kaunas, Lithuania, 49449
    • Research Site
  • Kaunas, Lithuania, LT-48426
    • Research Site
  • Kaunas, Lithuania, LT-49287
    • Research Site
  • Kaunas, Lithuania, LT-49427
    • Research Site
  • Kedainiai, Lithuania, LT-57445
    • Research Site
  • Klaipeda, Lithuania, LT-92288
    • Research Site
  • Klaipeda, Lithuania, LT-94198
    • Research Site
  • Panevezys, Lithuania, LT-37355
    • Research Site
  • Ukmerge, Lithuania, LT-20184
    • Research Site
  • Utena, Lithuania, LT-28151
    • Research Site
  • Vilnius, Lithuania, 08661
    • Research Site
  • Vilnius, Lithuania, 04318
    • Research Site
  • Vilnius, Lithuania, 09112
    • Research Site
• Malaysia
  • Alor Setar, Malaysia, 5460
    • Research Site
  • Batu Caves, Malaysia, 68100
    • Research Site
  • Kota Samarahan, Malaysia, 94300
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Research Site
  • Kuching, Malaysia, 93586
    • Research Site
  • Sungai Buloh, Malaysia, 47000
    • Research Site
  • Taiping, Malaysia, 34000
    • Research Site
• Mexico
  • Aguascalientes, Mexico, 20127
    • Research Site
  • Cuautla, Mexico, 62746
    • Research Site
  • Durango, Mexico, 34080
    • Research Site
  • Guadalajara, Mexico, 44670
    • Research Site
  • Mexico, Mexico, 06700
    • Research Site
  • Mexico, Mexico, 52763
    • Research Site
  • Mexico, Mexico, 6090
    • Research Site
  • Mexico, Mexico, 10700
    • Research Site
  • Monterrey, Mexico, 64710
    • Research Site
  • Puebla, Mexico, 72190
    • Research Site
  • Queretaro, Mexico, 76000
    • Research Site
  • San Luis Potosí, Mexico, 78240
    • Research Site
• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • Research Site
  • Amsterdam, Netherlands, 1081 HV
    • Research Site
  • Eindhoven, Netherlands, 5611 NV
    • Research Site
  • Groningen, Netherlands, 9711 SG
    • Research Site
  • Hardenberg, Netherlands, 7772 SE
    • Research Site
  • Hoogeveen, Netherlands, 7909 AA
    • Research Site
  • Meppel, Netherlands, 7943 KA
    • Research Site
  • Rotterdam, Netherlands, 3039 BD
    • Research Site
  • Sneek, Netherlands, 8601 ZK
    • Research Site
  • Utrecht, Netherlands, 3584 CX
    • Research Site
• New Zealand
  • Christchurch, New Zealand, 8024
    • Research Site
  • Christchurch, New Zealand, 8041
    • Research Site
  • Christchurch, New Zealand, 08011
    • Research Site
  • Hamilton, New Zealand, 3240
    • Research Site
  • Nelson, New Zealand, 7010
    • Research Site
  • Newtown, New Zealand, 6242
    • Research Site
  • Palmerston North, New Zealand, 4410
    • Research Site
  • Takapuna, New Zealand, 0622
    • Research Site
  • Tauranga, New Zealand, 3112
    • Research Site
  • Tauranga, New Zealand, 3143
    • Research Site
  • Wellington, New Zealand, 6021
    • Research Site
• Philippines
  • Cebu, Philippines, 6000
    • Research Site
  • Iloilo City, Philippines, 5000
    • Research Site
  • Manila, Philippines, 1000
    • Research Site
  • Marikina, Philippines, 1810
    • Research Site
  • Marikina City, Philippines, 1810
    • Research Site
  • Pasig, Philippines, 1605
    • Research Site
  • Quezon, Philippines, 1000
    • Research Site
  • Quezon, Philippines, 1110
    • Research Site
  • Quezon, Philippines, 1113
    • Research Site
  • Quezon City, Philippines, 1101
    • Research Site
  • San Juan, Philippines
    • Research Site
• Poland
  • Elbląg, Poland, 82-300
    • Research Site
  • Gdynia, Poland, 81-472
    • Research Site
  • Grodzisk Mazowiecki, Poland, 05-825
    • Research Site
  • Grudziadz, Poland, 86-300
    • Research Site
  • Katowice, Poland, 40-752
    • Research Site
  • Lublin, Poland, 20-090
    • Research Site
  • Ostrołęka, Poland, 07-400
    • Research Site
  • Poznań, Poland, 60-659
    • Research Site
  • Płock, Poland, 09-402
    • Research Site
  • Słupsk, Poland, 76-200
    • Research Site
  • Warszawa, Poland, 04-635
    • Research Site
  • Wroclaw, Poland, 50-127
    • Research Site
  • Wrocław, Poland, 51-124
    • Research Site
  • Wrocław, Poland, 50-403
    • Research Site
  • Łódź, Poland, 94-074
    • Research Site
  • Łęczna, Poland, 21-010
    • Research Site
• Romania
  • Bacau, Romania, 600164
    • Research Site
  • Bucharest, Romania, 010507
    • Research Site
  • Bucuresti, Romania, 042122
    • Research Site
  • Bucuresti, Romania, 010627
    • Research Site
  • Bucuresti, Romania, 020725
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  • Bucuresti, Romania, 030306
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  • Buzau, Romania, 120203
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  • Cluj Napoca, Romania, 400006
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  • Cluj Napoca, Romania, 400349
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  • Craiova, Romania, 200147
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  • Iasi, Romania, 700111
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  • Oradea, Romania, 410169
    • Research Site
  • Ploiesti, Romania, 100477
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  • Satu-Mare, Romania, 440055
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  • Timisoara, Romania, 300125
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  • Timișoara, Romania, 300456
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  • Zalau, Romania, 450129
    • Research Site
• Russian Federation
  • Ekaterinburg, Russian Federation, 620219
    • Research Site
  • Kemerovo, Russian Federation, 650002
    • Research Site
  • Krasnoyarsk, Russian Federation, 660022
    • Research Site
  • Moscow, Russian Federation, 129110
    • Research Site
  • Moscow, Russian Federation, 105120
    • Research Site
  • Nizhnii Novgorod, Russian Federation, 603018
    • Research Site
  • Novosibirsk, Russian Federation, 630087
    • Research Site
  • Saint Petersburg, Russian Federation, 196601
    • Research Site
  • St. Peterburg, Russian Federation, 195112
    • Research Site
  • St.Рetersburg, Russian Federation, 198035
    • Research Site
  • Thymen, Russian Federation, 625023
    • Research Site
  • Tomsk, Russian Federation, 634050
    • Research Site
  • Tomsk, Russian Federation, 634012
    • Research Site
  • Yaroslavl, Russian Federation, 150062
    • Research Site
  • Yaroslavl, Russian Federation, 150010
    • Research Site
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Research Site
  • Bratislava, Slovakia, 82606
    • Research Site
  • Bratislava, Slovakia, 813 69
    • Research Site
  • Kosice, Slovakia, 040 01
    • Research Site
  • Kosice, Slovakia, 04022
    • Research Site
  • Kosice, Slovakia, 044 24
    • Research Site
  • Lucenec, Slovakia, 984 01
    • Research Site
  • Presov, Slovakia, 080 01
    • Research Site
  • Roznava, Slovakia, 048 01
    • Research Site
  • Trebisov, Slovakia, 075 01
    • Research Site
  • Zilina, Slovakia, 010 01
    • Research Site
• South Africa
  • Boksburg, South Africa, 1459
    • Research Site
  • Brits, South Africa, 0250
    • Research Site
  • Cape Town, South Africa, 7700
    • Research Site
  • Cape Town, South Africa, 7500
    • Research Site
  • Cape Town, South Africa, 7460
    • Research Site
  • Centurion, South Africa, 0157
    • Research Site
  • Durban, South Africa, 4001
    • Research Site
  • Durban, South Africa, 4052
    • Research Site
  • Johannesburg, South Africa, 2198
    • Research Site
  • Kempton Park, South Africa, 1619
    • Research Site
  • Lenasia, South Africa, 1827
    • Research Site
  • Paarl, South Africa, 7646
    • Research Site
  • Parktown, South Africa, 2193
    • Research Site
  • Phoenix, South Africa, 4068
    • Research Site
  • Port Elizabeth, South Africa, 6014
    • Research Site
  • Potchefstroom, South Africa, 2531
    • Research Site
  • Pretoria, South Africa, 0101
    • Research Site
  • Pretoria, South Africa, 0001
    • Research Site
  • Pretoria, South Africa, 0014
    • Research Site
  • Somerset West, South Africa, 7130
    • Research Site
  • Soweto, South Africa, 2013
    • Research Site
  • Umkomaas, South Africa, 4170
    • Research Site
• Spain
  • A Coruña, Spain, 15006
    • Research Site
  • Alcalá de Henares, Spain, 28805
    • Research Site
  • Avila, Spain, 05004
    • Research Site
  • Ferrol, Spain, 15405
    • Research Site
  • Girona, Spain, 17007
    • Research Site
  • Granada, Spain, 18012
    • Research Site
  • Granada, Spain, 18004
    • Research Site
  • Lleida, Spain, 25198
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28007
    • Research Site
  • Madrid, Spain, 28702
    • Research Site
  • Manacor, Spain, 07500
    • Research Site
  • Málaga, Spain, 29006
    • Research Site
  • Palma de Mallorca, Spain, 07198
    • Research Site
  • Palma deMallorca, Spain, 07010
    • Research Site
  • Salamanca, Spain, 37003
    • Research Site
  • Sevilla, Spain, 41010
    • Research Site
  • Tarragona, Spain, 43007
    • Research Site
• Taiwan
  • Changhua, Taiwan, 500
    • Research Site
  • Kaohsiung, Taiwan, 80756
    • Research Site
  • Kaohsiung Hsien, Taiwan, 83301
    • Research Site
  • Kweishan Shiang, Taiwan, 333
    • Research Site
  • New Taipei City, Taiwan, 23148
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 433
    • Research Site
  • Tainan County, Taiwan
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
  • Taipei, Taiwan, 11490
    • Research Site
• Thailand
  • Bangkok, Thailand, 10400
    • Research Site
• Ukraine
  • Chernivtsi, Ukraine, 58022
    • Research Site
  • Dnepropetrovsk, Ukraine, 49006
    • Research Site
  • Dnipropetrovsk, Ukraine, 49027
    • Research Site
  • Donetck, Ukraine, 83045
    • Research Site
  • Donetsk, Ukraine, 83059
    • Research Site
  • Donetsk, Ukraine, 83114
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76000
    • Research Site
  • Kharkiv, Ukraine, 61039
    • Research Site
  • Kharkiv, Ukraine, 61037
    • Research Site
  • Kharkiv, Ukraine, 61178
    • Research Site
  • Kharkiv, Ukraine, 61029
    • Research Site
  • Kiev, Ukraine, 04114
    • Research Site
  • Kiev, Ukraine, 07050
    • Research Site
  • Kyiv, Ukraine, 2091
    • Research Site
  • Kyiv, Ukraine, 3680
    • Research Site
  • Odesa, Ukraine, 65114
    • Research Site
  • Odesa, Ukraine, 65025
    • Research Site
  • Sumy, Ukraine, 40022
    • Research Site
  • Ternopil, Ukraine, 46002
    • Research Site
  • Uzhgorod, Ukraine, 88014
    • Research Site
  • Vinnytsia, Ukraine, 21010
    • Research Site
  • Zaporizhia, Ukraine, 69001
    • Research Site
  • Zaporizhzhya, Ukraine, 69118
    • Research Site
  • Zhytomyr, Ukraine, 10002
    • Research Site
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZD
    • Research Site
  • Addlestone, United Kingdom, KT15 2BH
    • Research Site
  • Birmingham, United Kingdom, B9 5SS
    • Research Site
  • Blackpool, United Kingdom, FY4 3AD
    • Research Site
  • Bradford, United Kingdom, BD9 6RJ
    • Research Site
  • Bristol, United Kingdom, BS10 5NB
    • Research Site
  • Cambridge, United Kingdom, CB2 0QQ
    • Research Site
  • Chippenham, United Kingdom, SN14 6GT
    • Research Site
  • Coventry, United Kingdom, CV2 2DX
    • Research Site
  • Dundee, United Kingdom, DD1 9SY
    • Research Site
  • Edinburgh, United Kingdom, EH4 2XU
    • Research Site
  • Glasgow, United Kingdom, G12 8TA
    • Research Site
  • Hull, United Kingdom, HU3 2JZ
    • Research Site
  • Inverness, United Kingdom, IV2 3JH
    • Research Site
  • Irvine, United Kingdom, KA12 0AY
    • Research Site
  • Leicester, United Kingdom, Le5 4PW
    • Research Site
  • Liverpool, United Kingdom, L7 8XP
    • Research Site
  • Manchester, United Kingdom, M8 5RB
    • Research Site
  • Northampton, United Kingdom, NN1 5BD
    • Research Site
  • Ormskirk, United Kingdom, L39 2AZ
    • Research Site
  • Peterborough, United Kingdom, PE8 6PL
    • Research Site
  • Plymouth, United Kingdom, PL6 8BX
    • Research Site
  • Plymouth, United Kingdom, PL5 3JB
    • Research Site
  • Redhill, United Kingdom, RH1 5RH
    • Research Site
  • Sheffield, United Kingdom, S5 7AU
    • Research Site
  • Suffolk, United Kingdom, IP33 2QZ
    • Research Site
  • Swansea, United Kingdom, SN6 6NL
    • Research Site
  • Trowbridge, United Kingdom, BA14 8QA
    • Research Site
  • West Sussex, United Kingdom, RH10 7DX
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Research Site
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Research Site
    • Phoenix, Arizona, United States, 85012
      • Research Site
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Research Site
    • Little Rock, Arkansas, United States, 72204
      • Research Site
  • California
    • Chula Vista, California, United States, 91911-1350
      • Research Site
    • Concord, California, United States, 94520
      • Research Site
    • Escondido, California, United States, 92029
      • Research Site
    • Fullerton, California, United States, 92835
      • Research Site
    • Greenbrae, California, United States, 94904
      • Research Site
    • La Mesa, California, United States, 91942
      • Research Site
    • Laguna Hills, California, United States, 92653
      • Research Site
    • Long Beach, California, United States, 90822
      • Research Site
    • Los Angeles, California, United States, 90033
      • Research Site
    • Northridge, California, United States, 91325
      • Research Site
    • Oceanside, California, United States, 92056
      • Research Site
    • Orange, California, United States, 92868
      • Research Site
    • Redondo Beach, California, United States, 90277
      • Research Site
    • San Diego, California, United States, 92120
      • Research Site
    • San Diego, California, United States, 92161
      • Research Site
    • Sylmar, California, United States, 91342
      • Research Site
    • Torrance, California, United States, 90505
      • Research Site
    • Tustin, California, United States, 92780
      • Research Site
    • Victorville, California, United States, 92392
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
    • Colorado Springs, Colorado, United States, 80920
      • Research Site
    • Littleton, Colorado, United States, 80120
      • Research Site
  • Connecticut
    • Thomaston, Connecticut, United States, 06787
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Research Site
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Research Site
    • Fort Lauderdale, Florida, United States, 33308
      • Research Site
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Sarasota, Florida, United States, 34239
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Research Site
    • Atlanta, Georgia, United States, 30339
      • Research Site
    • Decatur, Georgia, United States, 30033
      • Research Site
    • Marietta, Georgia, United States, 30067
      • Research Site
    • Roswell, Georgia, United States, 30076
      • Research Site
  • Idaho
    • Pocatello, Idaho, United States, 83201
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Research Site
    • Hines, Illinois, United States, 60141
      • Research Site
    • Rock Island, Illinois, United States, 61201
      • Research Site
    • Springfield, Illinois, United States, 62704
      • Research Site
  • Indiana
    • Avon, Indiana, United States, 46123
      • Research Site
    • Gary, Indiana, United States, 46403
      • Research Site
    • Indianapolis, Indiana, United States, 46260
      • Research Site
  • Iowa
    • Des Moines, Iowa, United States, 50263
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Research Site
  • Kentucky
    • Covington, Kentucky, United States, 41011
      • Research Site
    • Evansville, Kentucky, United States, 47713
      • Research Site
    • Lexington, Kentucky, United States, 40502
      • Research Site
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Research Site
  • Maine
    • Auburn, Maine, United States, 04210
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Research Site
    • Randallstown, Maryland, United States, 21133
      • Research Site
    • Rockville, Maryland, United States, 20874
      • Research Site
  • Michigan
    • Alpena, Michigan, United States, 49707
      • Research Site
    • Ann Arbor, Michigan, United States, 48109
      • Research Site
    • Bloomfield Hills, Michigan, United States, 48302
      • Research Site
    • Detroit, Michigan, United States, 48202
      • Research Site
    • Detroit, Michigan, United States, 48201
      • Research Site
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Research Site
    • Minneapolis, Minnesota, United States, 55454
      • Research Site
    • Minneapolis, Minnesota, United States, 55416
      • Research Site
    • Saint Cloud, Minnesota, United States, 56303
      • Research Site
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Research Site
    • Chesterfield, Missouri, United States, 63017
      • Research Site
  • Montana
    • Billings, Montana, United States, 59101
      • Research Site
    • Butte, Montana, United States, 59701
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68154
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Research Site
    • Reno, Nevada, United States, 89511
      • Research Site
  • New Jersey
    • Hamilton, New Jersey, United States, 08690
      • Research Site
    • Lyons, New Jersey, United States, 07939
      • Research Site
    • Margate City, New Jersey, United States, 08402
      • Research Site
    • South Plainfield, New Jersey, United States, 07080
      • Research Site
  • New York
    • Albany, New York, United States, 12203
      • Research Site
    • Bronx, New York, United States, 10461
      • Research Site
    • Manhasset, New York, United States, 11030
      • Research Site
    • New York, New York, United States, 10032
      • Research Site
    • New York, New York, United States, 10001
      • Research Site
    • North Massapequa, New York, United States, 11758
      • Research Site
    • Rosedale, New York, United States, 11422
      • Research Site
    • Smithtown, New York, United States, 11787
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Research Site
    • Durham, North Carolina, United States, 27705
      • Research Site
    • Greensboro, North Carolina, United States, 27401
      • Research Site
    • Hickory, North Carolina, United States, 28602
      • Research Site
    • Mooresville, North Carolina, United States, 28117
      • Research Site
    • Morehead City, North Carolina, United States, 28557
      • Research Site
    • Raleigh, North Carolina, United States, 27609
      • Research Site
    • Salisbury, North Carolina, United States, 28144
      • Research Site
    • Statesville, North Carolina, United States, 28625
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Research Site
  • Ohio
    • Barberton, Ohio, United States, 44203
      • Research Site
    • Canal Fulton, Ohio, United States, 44614
      • Research Site
    • Cleveland, Ohio, United States, 44195
      • Research Site
    • Cleveland, Ohio, United States, 44122
      • Research Site
    • Cleveland, Ohio, United States, 44121
      • Research Site
    • Columbus, Ohio, United States, 43210
      • Research Site
    • Kettering, Ohio, United States, 45429
      • Research Site
    • Mentor, Ohio, United States, 44060
      • Research Site
    • Toledo, Ohio, United States, 43614
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Research Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Research Site
    • Feasterville, Pennsylvania, United States, 19053
      • Research Site
    • Lansdale, Pennsylvania, United States, 19446
      • Research Site
    • Newport, Pennsylvania, United States, 17011
      • Research Site
    • Newport, Pennsylvania, United States, 17074
      • Research Site
    • Penndel, Pennsylvania, United States, 19047
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19114
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19134
      • Research Site
    • Tipton, Pennsylvania, United States, 16684
      • Research Site
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Research Site
    • Murrells Inlet, South Carolina, United States, 29576
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Research Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Research Site
    • Chattanooga, Tennessee, United States, 37403
      • Research Site
    • Jackson, Tennessee, United States, 38305
      • Research Site
    • Johnson City, Tennessee, United States, 37601
      • Research Site
    • Kingsport, Tennessee, United States, 37660
      • Research Site
    • Knoxville, Tennessee, United States, 37912
      • Research Site
    • McKenzie, Tennessee, United States, 38201
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Research Site
  • Texas
    • Arlington, Texas, United States, 76012
      • Research Site
    • Dallas, Texas, United States, 75390
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
    • Dallas, Texas, United States, 75251
      • Research Site
    • Dallas, Texas, United States, 75218
      • Research Site
    • El Paso, Texas, United States, 79925
      • Research Site
    • Friendswood, Texas, United States, 77546
      • Research Site
    • Houston, Texas, United States, 77030
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • Webster, Texas, United States, 77598
      • Research Site
  • Utah
    • Layton, Utah, United States, 84041
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient has type 2 diabetes mellitus
• Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents
• Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.

Exclusion Criteria:

• Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
• Patient has ever been treated with an approved or investigational GLP-1 receptor agonist.
• Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
• Patient has a planned or anticipated revascularization procedure.
• Pregnancy or planned pregnancy during the trial period.
• Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m2.
• Patient has a history of gastroparesis or pancreatitis.
• Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of >40 ng/L at baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Subcutaneous injection, matching volume of placebo, administered once weekly.
Experimental: Exenatide Once Weekly	Drug: Exenatide Once Weekly; Subcutaneous injection, 2 mg, administered once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Outcome MACE Events	The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Primary Safety Outcome MACE Events	The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Outcome All-Cause Mortality	The secondary efficacy outcome variable is defined as the all-cause mortality (deaths). The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome CV Death	Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome MI	Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome Stroke	Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome Hospitalization for ACS	The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome. The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome Hospitalization for HF	The secondary efficacy outcome variable is defined as hospitalization for heart failure. The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Stephanie Gustavson, PhD, AstraZeneca; Study Director: Group Director Global Clinical Research, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
• Davis TME, Giczewska A, Lokhnygina Y, Mentz RJ, Sattar N, Holman RR; EXSCEL Study Group. Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Cardiovasc Diabetol. 2022 Jun 27;21(1):116. doi: 10.1186/s12933-022-01555-z.
• Becker F, Dakin HA, Reed SD, Li Y, Leal J, Gustavson SM, Wittbrodt E, Hernandez AF, Gray AM, Holman RR. Lifetime cost-effectiveness simulation of once-weekly exenatide in type 2 diabetes: A cost-utility analysis based on the EXSCEL trial. Diabetes Res Clin Pract. 2022 Jan;183:109152. doi: 10.1016/j.diabres.2021.109152. Epub 2021 Nov 20.
• Bethel MA, Stevens SR, Buse JB, Choi J, Gustavson SM, Iqbal N, Lokhnygina Y, Mentz RJ, Patel RA, Ohman P, Schernthaner G, Lecube A, Hernandez AF, Holman RR. Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes. Circulation. 2020 Apr 28;141(17):1360-1370. doi: 10.1161/CIRCULATIONAHA.119.043353. Epub 2020 Feb 26.
• Standl E, Stevens SR, Lokhnygina Y, Bethel MA, Buse JB, Gustavson SM, Maggioni AP, Mentz RJ, Hernandez AF, Holman RR; EXSCEL Study Group. Confirming the Bidirectional Nature of the Association Between Severe Hypoglycemic and Cardiovascular Events in Type 2 Diabetes: Insights From EXSCEL. Diabetes Care. 2020 Mar;43(3):643-652. doi: 10.2337/dc19-1079. Epub 2019 Dec 27.
• Reed SD, Li Y, Dakin HA, Becker F, Leal J, Gustavson SM, Kartman B, Wittbrodt E, Mentz RJ, Pagidipati NJ, Bethel MA, Gray AM, Holman RR, Hernandez AF; EXSCEL Study Group. Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Diabetes Care. 2020 Feb;43(2):374-381. doi: 10.2337/dc19-0950. Epub 2019 Dec 5.
• Badjatiya A, Merrill P, Buse JB, Goodman SG, Katona B, Iqbal N, Pagidipati NJ, Sattar N, Holman RR, Hernandez AF, Mentz RJ, Patel MR, Jones WS. Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results From the EXSCEL Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e008018. doi: 10.1161/CIRCINTERVENTIONS.119.008018. Epub 2019 Nov 22.
• Clegg LE, Penland RC, Bachina S, Boulton DW, Thuresson M, Heerspink HJL, Gustavson S, Sjostrom CD, Ruggles JA, Hernandez AF, Buse JB, Mentz RJ, Holman RR. Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial. Cardiovasc Diabetol. 2019 Oct 22;18(1):138. doi: 10.1186/s12933-019-0942-x.
• Fudim M, White J, Pagidipati NJ, Lokhnygina Y, Wainstein J, Murin J, Iqbal N, Ohman P, Lopes RD, Reicher B, Holman RR, Hernandez AF, Mentz RJ. Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial. Circulation. 2019 Nov 12;140(20):1613-1622. doi: 10.1161/CIRCULATIONAHA.119.041659. Epub 2019 Sep 23.
• Bethel MA, Patel RA, Thompson VP, Merrill P, Reed SD, Li Y, Ahmadi S, Katona BG, Gustavson SM, Ohman P, Iqbal N, Gagel RF, Hernandez AF, Buse JB, Holman RR; EXSCEL Study Group. Changes in Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL). Diabetes Care. 2019 Jun;42(6):1075-1080. doi: 10.2337/dc18-2028. Epub 2019 Apr 22.
• Mentz RJ, Bethel MA, Merrill P, Lokhnygina Y, Buse JB, Chan JC, Felicio JS, Goodman SG, Choi J, Gustavson SM, Iqbal N, Lopes RD, Maggioni AP, Ohman P, Pagidipati NJ, Poulter NR, Ramachandran A, Reicher B, Holman RR, Hernandez AF; EXSCEL Study Group. Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial. J Am Heart Assoc. 2018 Oct 2;7(19):e009304. doi: 10.1161/JAHA.118.009304.
• Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP, Ohman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF; EXSCEL Study Group. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Sep 28;377(13):1228-1239. doi: 10.1056/NEJMoa1612917. Epub 2017 Sep 14.
• Mentz RJ, Bethel MA, Gustavson S, Thompson VP, Pagidipati NJ, Buse JB, Chan JC, Iqbal N, Maggioni AP, Marso SP, Ohman P, Poulter N, Ramachandran A, Zinman B, Hernandez AF, Holman RR. Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Am Heart J. 2017 May;187:1-9. doi: 10.1016/j.ahj.2017.02.005. Epub 2017 Feb 12.
• Holman RR, Bethel MA, George J, Sourij H, Doran Z, Keenan J, Khurmi NS, Mentz RJ, Oulhaj A, Buse JB, Chan JC, Iqbal N, Kundu S, Maggioni AP, Marso SP, Ohman P, Pencina MJ, Poulter N, Porter LE, Ramachandran A, Zinman B, Hernandez AF. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. Am Heart J. 2016 Apr;174:103-10. doi: 10.1016/j.ahj.2015.12.009. Epub 2015 Dec 21.
• Gaebler JA, Soto-Campos G, Alperin P, Cohen M, Blickensderfer A, Wintle M, Maggs D, Hoogwerf B, Han J, Pencek R, Peskin B. Health and economic outcomes for exenatide once weekly, insulin, and pioglitazone therapies in the treatment of type 2 diabetes: a simulation analysis. Vasc Health Risk Manag. 2012;8:255-64. doi: 10.2147/VHRM.S28744. Epub 2012 Apr 23.

Helpful Links

• d5551c00003_bcb109_csp_amendment_6_updated_Redacted
• d5551c00003 SAP Redacted
• d5551c00003 CSP Redacted

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2010
• Primary Completion (Actual): April 21, 2017
• Study Completion (Actual): April 24, 2017

Study Registration Dates

• First Submitted: June 10, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Amylin; cardiovascular; Bydureon; exenatide once weekly
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: D5551C00003; MB001-002 (Other Identifier: Bristol Myers Squibb); BCB109 (Other Identifier: Bristol-Myers Squibb)