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Clinical Trial Details

Trial ID: L6071
Source ID: NCT01144338
Associated Drug: Exenatide Once Weekly
Title: 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
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01144338/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Exenatide Once Weekly|DRUG: Placebo
Outcome Measures: Primary: 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: 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).
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 14752
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-06-18
Completion Date: 2017-04-24
Results First Posted: 2018-08-08
Last Update Posted: 2018-08-08
Locations: Research Site, Birmingham, Alabama, 35294, United States|Research Site, Glendale, Arizona, 85306, United States|Research Site, Phoenix, Arizona, 85012, United States|Research Site, Jonesboro, Arkansas, 72401, United States|Research Site, Little Rock, Arkansas, 72204, United States|Research Site, Chula Vista, California, 91911-1350, United States|Research Site, Concord, California, 94520, United States|Research Site, Escondido, California, 92029, United States|Research Site, Fullerton, California, 92835, United States|Research Site, Greenbrae, California, 94904, United States|Research Site, La Mesa, California, 91942, United States|Research Site, Laguna Hills, California, 92653, United States|Research Site, Long Beach, California, 90822, United States|Research Site, Los Angeles, California, 90033, United States|Research Site, Northridge, California, 91325, United States|Research Site, Oceanside, California, 92056, United States|Research Site, Orange, California, 92868, United States|Research Site, Redondo Beach, California, 90277, United States|Research Site, San Diego, California, 92120, United States|Research Site, San Diego, California, 92161, United States|Research Site, Sylmar, California, 91342, United States|Research Site, Torrance, California, 90505, United States|Research Site, Tustin, California, 92780, United States|Research Site, Victorville, California, 92392, United States|Research Site, Aurora, Colorado, 80045, United States|Research Site, Colorado Springs, Colorado, 80920, United States|Research Site, Littleton, Colorado, 80120, United States|Research Site, Thomaston, Connecticut, 06787, United States|Research Site, Washington, District of Columbia, 20037, United States|Research Site, Cape Coral, Florida, 33904, United States|Research Site, Fort Lauderdale, Florida, 33308, United States|Research Site, Jacksonville, Florida, 32216, United States|Research Site, Sarasota, Florida, 34239, United States|Research Site, Atlanta, Georgia, 30339, United States|Research Site, Atlanta, Georgia, 30342, United States|Research Site, Decatur, Georgia, 30033, United States|Research Site, Marietta, Georgia, 30067, United States|Research Site, Roswell, Georgia, 30076, United States|Research Site, Pocatello, Idaho, 83201, United States|Research Site, Chicago, Illinois, 60607, United States|Research Site, Hines, Illinois, 60141, United States|Research Site, Rock Island, Illinois, 61201, United States|Research Site, Springfield, Illinois, 62704, United States|Research Site, Avon, Indiana, 46123, United States|Research Site, Gary, Indiana, 46403, United States|Research Site, Indianapolis, Indiana, 46260, United States|Research Site, Des Moines, Iowa, 50263, United States|Research Site, Kansas City, Kansas, 66160, United States|Research Site, Covington, Kentucky, 41011, United States|Research Site, Evansville, Kentucky, 47713, United States|Research Site, Lexington, Kentucky, 40502, United States|Research Site, Alexandria, Louisiana, 71301, United States|Research Site, Auburn, Maine, 04210, United States|Research Site, Baltimore, Maryland, 21215, United States|Research Site, Randallstown, Maryland, 21133, United States|Research Site, Rockville, Maryland, 20874, United States|Research Site, Alpena, Michigan, 49707, United States|Research Site, Ann Arbor, Michigan, 48109, United States|Research Site, Bloomfield Hills, Michigan, 48302, United States|Research Site, Detroit, Michigan, 48201, United States|Research Site, Detroit, Michigan, 48202, United States|Research Site, Duluth, Minnesota, 55805, United States|Research Site, Minneapolis, Minnesota, 55416, United States|Research Site, Minneapolis, Minnesota, 55454, United States|Research Site, Saint Cloud, Minnesota, 56303, United States|Research Site, Bridgeton, Missouri, 63044, United States|Research Site, Chesterfield, Missouri, 63017, United States|Research Site, Billings, Montana, 59101, United States|Research Site, Butte, Montana, 59701, United States|Research Site, Omaha, Nebraska, 68154, United States|Research Site, Las Vegas, Nevada, 89121, United States|Research Site, Reno, Nevada, 89511, United States|Research Site, Hamilton, New Jersey, 08690, United States|Research Site, Lyons, New Jersey, 07939, United States|Research Site, Margate City, New Jersey, 08402, United States|Research Site, South Plainfield, New Jersey, 07080, United States|Research Site, Albany, New York, 12203, United States|Research Site, Bronx, New York, 10461, United States|Research Site, Manhasset, New York, 11030, United States|Research Site, New York, New York, 10001, United States|Research Site, New York, New York, 10032, United States|Research Site, North Massapequa, New York, 11758, United States|Research Site, Rosedale, New York, 11422, United States|Research Site, Smithtown, New York, 11787, United States|Research Site, Charlotte, North Carolina, 28207, United States|Research Site, Durham, North Carolina, 27705, United States|Research Site, Greensboro, North Carolina, 27401, United States|Research Site, Hickory, North Carolina, 28602, United States|Research Site, Mooresville, North Carolina, 28117, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Raleigh, North Carolina, 27609, United States|Research Site, Salisbury, North Carolina, 28144, United States|Research Site, Statesville, North Carolina, 28625, United States|Research Site, Wilmington, North Carolina, 28401, United States|Research Site, Winston-Salem, North Carolina, 27103, United States|Research Site, Fargo, North Dakota, 58103, United States|Research Site, Barberton, Ohio, 44203, United States|Research Site, Canal Fulton, Ohio, 44614, United States|Research Site, Cleveland, Ohio, 44121, United States|Research Site, Cleveland, Ohio, 44122, United States|Research Site, Cleveland, Ohio, 44195, United States|Research Site, Columbus, Ohio, 43210, United States|Research Site, Kettering, Ohio, 45429, United States|Research Site, Mentor, 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United States|Research Site, Bristol, Tennessee, 37620, United States|Research Site, Chattanooga, Tennessee, 37403, United States|Research Site, Jackson, Tennessee, 38305, United States|Research Site, Johnson City, Tennessee, 37601, United States|Research Site, Kingsport, Tennessee, 37660, United States|Research Site, Knoxville, Tennessee, 37912, United States|Research Site, McKenzie, Tennessee, 38201, United States|Research Site, Nashville, Tennessee, 37203, United States|Research Site, Arlington, Texas, 76012, United States|Research Site, Dallas, Texas, 75218, United States|Research Site, Dallas, Texas, 75231, United States|Research Site, Dallas, Texas, 75251, United States|Research Site, Dallas, Texas, 75390, United States|Research Site, El Paso, Texas, 79925, United States|Research Site, Friendswood, Texas, 77546, United States|Research Site, Houston, Texas, 77030, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Webster, Texas, 77598, United 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Site, North York, Ontario, M3M 3E5, Canada|Research Site, Ottawa, Ontario, K1H 1A2, Canada|Research Site, Scarborough, Ontario, M1E 5E9, Canada|Research Site, Smiths Falls, Ontario, K7A 4W8, Canada|Research Site, Toronto, Ontario, M5C 2T2, Canada|Research Site, Toronto, Ontario, M5T 3L9, Canada|Research Site, Laval, Quebec, H7T 2P5, Canada|Research Site, Montreal, Quebec, H1M 1B1, Canada|Research Site, Montreal, Quebec, H3A 1A1, Canada|Research Site, Sainte Foy, Quebec, G1V 4G5, Canada|Research Site, Terrebonne, Quebec, J6V 1S8, Canada|Research Site, Osorno, 5290000, Chile|Research Site, Puerto Varas, Chile|Research Site, Santiago, 7500710, Chile|Research Site, Santiago, 8053095, Chile|Research Site, Temuco, 4781173, Chile|Research Site, Vina del Mar, 2570017, Chile|Research Site, Beijing, 100029, China|Research Site, Beijing, 100034, China|Research Site, Beijing, 100044, China|Research Site, Beijing, 100853, China|Research Site, Chongqing, 400010, China|Research Site, Chongqing, 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Korea, Republic of|Research Site, Gwangjin-gu, 110-744, Korea, Republic of|Research Site, Gyeonggi-do, 411-706, Korea, Republic of|Research Site, Incheon, 403-720, Korea, Republic of|Research Site, Seongnam, 463-707, Korea, Republic of|Research Site, Seoul, 08308, Korea, Republic of|Research Site, Seoul, 110746, Korea, Republic of|Research Site, Seoul, 134-727, Korea, Republic of|Research Site, Seoul, 135-720, Korea, Republic of|Research Site, Seoul, 137-701, Korea, Republic of|Research Site, Suwon-si, 16247, Korea, Republic of|Research Site, Suwon, 443-721, Korea, Republic of|Research Site, Ulsan, 682-714, Korea, Republic of|Research Site, Daugavpils, 5417, Latvia|Research Site, Jelgava, LV-3000, Latvia|Research Site, Kuldiga, LV-3301, Latvia|Research Site, Kuldiga, LV3301, Latvia|Research Site, Ogre, LV-5001, Latvia|Research Site, Riga, 1012, Latvia|Research Site, Riga, LV-1002, Latvia|Research Site, Riga, LV-1050, Latvia|Research Site, Riga, LV1002, Latvia|Research Site, Talsi, 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Romania|Research Site, Oradea, 410169, Romania|Research Site, Ploiesti, 100477, Romania|Research Site, Satu-Mare, 440055, Romania|Research Site, Timisoara, 300125, Romania|Research Site, Timișoara, 300456, Romania|Research Site, Zalau, 450129, Romania|Research Site, Ekaterinburg, 620219, Russian Federation|Research Site, Kemerovo, 650002, Russian Federation|Research Site, Krasnoyarsk, 660022, Russian Federation|Research Site, Moscow, 105120, Russian Federation|Research Site, Moscow, 129110, Russian Federation|Research Site, Nizhnii Novgorod, 603018, Russian Federation|Research Site, Novosibirsk, 630087, Russian Federation|Research Site, Saint Petersburg, 196601, Russian Federation|Research Site, St. Peterburg, 195112, Russian Federation|Research Site, St.Рetersburg, 198035, Russian Federation|Research Site, Thymen, 625023, Russian Federation|Research Site, Tomsk, 634012, Russian Federation|Research Site, Tomsk, 634050, Russian Federation|Research Site, Yaroslavl, 150010, Russian Federation|Research Site, Yaroslavl, 150062, Russian Federation|Research Site, Bardejov, 085 01, Slovakia|Research Site, Bratislava, 813 69, Slovakia|Research Site, Bratislava, 82606, Slovakia|Research Site, Kosice, 040 01, Slovakia|Research Site, Kosice, 04022, Slovakia|Research Site, Kosice, 044 24, Slovakia|Research Site, Lucenec, 984 01, Slovakia|Research Site, Presov, 080 01, Slovakia|Research Site, Roznava, 048 01, Slovakia|Research Site, Trebisov, 075 01, Slovakia|Research Site, Zilina, 010 01, Slovakia|Research Site, Boksburg, 1459, South Africa|Research Site, Brits, 0250, South Africa|Research Site, Cape Town, 7460, South Africa|Research Site, Cape Town, 7500, South Africa|Research Site, Cape Town, 7700, South Africa|Research Site, Centurion, 0157, South Africa|Research Site, Durban, 4001, South Africa|Research Site, Durban, 4052, South Africa|Research Site, Johannesburg, 2198, South Africa|Research Site, Kempton Park, 1619, South Africa|Research Site, Lenasia, 1827, South Africa|Research Site, Paarl, 7646, South Africa|Research Site, Parktown, 2193, South Africa|Research Site, Phoenix, 4068, South Africa|Research Site, Port Elizabeth, 6014, South Africa|Research Site, Potchefstroom, 2531, South Africa|Research Site, Pretoria, 0001, South Africa|Research Site, Pretoria, 0014, South Africa|Research Site, Pretoria, 0101, South Africa|Research Site, Somerset West, 7130, South Africa|Research Site, Soweto, 2013, South Africa|Research Site, Umkomaas, 4170, South Africa|Research Site, A Coruña, 15006, Spain|Research Site, Alcalá de Henares, 28805, Spain|Research Site, Avila, 05004, Spain|Research Site, Ferrol, 15405, Spain|Research Site, Girona, 17007, Spain|Research Site, Granada, 18004, Spain|Research Site, Granada, 18012, Spain|Research Site, Lleida, 25198, Spain|Research Site, Madrid, 28007, Spain|Research Site, Madrid, 28034, Spain|Research Site, Madrid, 28046, Spain|Research Site, Madrid, 28702, Spain|Research Site, Manacor, 07500, Spain|Research Site, Málaga, 29006, Spain|Research Site, Palma de Mallorca, 07198, Spain|Research Site, Palma deMallorca, 07010, Spain|Research Site, Salamanca, 37003, Spain|Research Site, Sevilla, 41010, Spain|Research Site, Tarragona, 43007, Spain|Research Site, Changhua, 500, Taiwan|Research Site, Kaohsiung Hsien, 83301, Taiwan|Research Site, Kaohsiung, 80756, Taiwan|Research Site, Kweishan Shiang, 333, Taiwan|Research Site, New Taipei City, 23148, Taiwan|Research Site, Taichung, 40705, Taiwan|Research Site, Taichung, 433, Taiwan|Research Site, Tainan County, Taiwan|Research Site, Taipei, 100, Taiwan|Research Site, Taipei, 11490, Taiwan|Research Site, Bangkok, 10400, Thailand|Research Site, Chernivtsi, 58022, Ukraine|Research Site, Dnepropetrovsk, 49006, Ukraine|Research Site, Dnipropetrovsk, 49027, Ukraine|Research Site, Donetck, 83045, Ukraine|Research Site, Donetsk, 83059, Ukraine|Research Site, Donetsk, 83114, Ukraine|Research Site, Ivano-Frankivsk, 76000, Ukraine|Research Site, Kharkiv, 61029, Ukraine|Research Site, Kharkiv, 61037, Ukraine|Research Site, Kharkiv, 61039, Ukraine|Research Site, Kharkiv, 61178, Ukraine|Research Site, Kiev, 04114, Ukraine|Research Site, Kiev, 07050, Ukraine|Research Site, Kyiv, 2091, Ukraine|Research Site, Kyiv, 3680, Ukraine|Research Site, Odesa, 65025, Ukraine|Research Site, Odesa, 65114, Ukraine|Research Site, Sumy, 40022, Ukraine|Research Site, Ternopil, 46002, Ukraine|Research Site, Uzhgorod, 88014, Ukraine|Research Site, Vinnytsia, 21010, Ukraine|Research Site, Zaporizhia, 69001, Ukraine|Research Site, Zaporizhzhya, 69118, Ukraine|Research Site, Zhytomyr, 10002, Ukraine|Research Site, Aberdeen, AB25 2ZD, United Kingdom|Research Site, Addlestone, KT15 2BH, United Kingdom|Research Site, Birmingham, B9 5SS, United Kingdom|Research Site, Blackpool, FY4 3AD, United Kingdom|Research Site, Bradford, BD9 6RJ, United Kingdom|Research Site, Bristol, BS10 5NB, United Kingdom|Research Site, Cambridge, CB2 0QQ, United Kingdom|Research Site, Chippenham, SN14 6GT, United Kingdom|Research Site, Coventry, CV2 2DX, United Kingdom|Research Site, Dundee, DD1 9SY, United Kingdom|Research Site, Edinburgh, EH4 2XU, United Kingdom|Research Site, Glasgow, G12 8TA, United Kingdom|Research Site, Hull, HU3 2JZ, United Kingdom|Research Site, Inverness, IV2 3JH, United Kingdom|Research Site, Irvine, KA12 0AY, United Kingdom|Research Site, Leicester, LE5 4PW, United Kingdom|Research Site, Liverpool, L7 8XP, United Kingdom|Research Site, Manchester, M8 5RB, United Kingdom|Research Site, Northampton, NN1 5BD, United Kingdom|Research Site, Ormskirk, L39 2AZ, United Kingdom|Research Site, Peterborough, PE8 6PL, United Kingdom|Research Site, Plymouth, PL5 3JB, United Kingdom|Research Site, Plymouth, PL6 8BX, United Kingdom|Research Site, Redhill, RH1 5RH, United Kingdom|Research Site, Sheffield, S5 7AU, United Kingdom|Research Site, Suffolk, IP33 2QZ, United Kingdom|Research Site, Swansea, SN6 6NL, United Kingdom|Research Site, Trowbridge, BA14 8QA, United Kingdom|Research Site, West Sussex, RH10 7DX, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01144338

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress