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
NCT ID: NCT01144338
Last Updated: 2018-08-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
14752 participants
INTERVENTIONAL
2010-06-18
2017-04-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension
NCT00894322
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
NCT00935532
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
NCT00308139
Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
NCT00103935
Safety and Efficacy of Exenatide as Monotherapy
NCT00381342
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exenatide Once Weekly
Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.
Placebo
Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.
Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephanie Gustavson, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Group Director Global Clinical Research
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Jonesboro, Arkansas, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Chula Vista, California, United States
Research Site
Concord, California, United States
Research Site
Escondido, California, United States
Research Site
Fullerton, California, United States
Research Site
Greenbrae, California, United States
Research Site
La Mesa, California, United States
Research Site
Laguna Hills, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Northridge, California, United States
Research Site
Oceanside, California, United States
Research Site
Orange, California, United States
Research Site
Redondo Beach, California, United States
Research Site
San Diego, California, United States
Research Site
San Diego, California, United States
Research Site
Sylmar, California, United States
Research Site
Torrance, California, United States
Research Site
Tustin, California, United States
Research Site
Victorville, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Littleton, Colorado, United States
Research Site
Thomaston, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Cape Coral, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Decatur, Georgia, United States
Research Site
Marietta, Georgia, United States
Research Site
Roswell, Georgia, United States
Research Site
Pocatello, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Hines, Illinois, United States
Research Site
Rock Island, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Avon, Indiana, United States
Research Site
Gary, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Des Moines, Iowa, United States
Research Site
Kansas City, Kansas, United States
Research Site
Covington, Kentucky, United States
Research Site
Evansville, Kentucky, United States
Research Site
Lexington, Kentucky, United States
Research Site
Alexandria, Louisiana, United States
Research Site
Auburn, Maine, United States
Research Site
Baltimore, Maryland, United States
Research Site
Randallstown, Maryland, United States
Research Site
Rockville, Maryland, United States
Research Site
Alpena, Michigan, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Bloomfield Hills, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Duluth, Minnesota, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Saint Cloud, Minnesota, United States
Research Site
Bridgeton, Missouri, United States
Research Site
Chesterfield, Missouri, United States
Research Site
Billings, Montana, United States
Research Site
Butte, Montana, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Reno, Nevada, United States
Research Site
Hamilton, New Jersey, United States
Research Site
Lyons, New Jersey, United States
Research Site
Margate City, New Jersey, United States
Research Site
South Plainfield, New Jersey, United States
Research Site
Albany, New York, United States
Research Site
Manhasset, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
North Massapequa, New York, United States
Research Site
Rosedale, New York, United States
Research Site
Smithtown, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Hickory, North Carolina, United States
Research Site
Mooresville, North Carolina, United States
Research Site
Morehead City, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Salisbury, North Carolina, United States
Research Site
Statesville, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Fargo, North Dakota, United States
Research Site
Barberton, Ohio, United States
Research Site
Canal Fulton, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Kettering, Ohio, United States
Research Site
Mentor, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Bethlehem, Pennsylvania, United States
Research Site
Feasterville, Pennsylvania, United States
Research Site
Lansdale, Pennsylvania, United States
Research Site
Newport, Pennsylvania, United States
Research Site
Newport, Pennsylvania, United States
Research Site
Penndel, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Tipton, Pennsylvania, United States
Research Site
Pawtucket, Rhode Island, United States
Research Site
Charleston, South Carolina, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Murrells Inlet, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Bristol, Tennessee, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Jackson, Tennessee, United States
Research Site
Johnson City, Tennessee, United States
Research Site
Kingsport, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
McKenzie, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Arlington, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Friendswood, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Webster, Texas, United States
Research Site
Layton, Utah, United States
Research Site
Buenos Aires, , Argentina
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
Research Site
Capital Federal, , Argentina
Research Site
CiudadAutonoma de Buenos Aires, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Godoy Cruz, , Argentina
Research Site
Mar Del Plata Buenos Aires, , Argentina
Research Site
Rosario, , Argentina
Research Site
Salta, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
San Salvador de Jujuy, , Argentina
Research Site
Santa Rosa, , Argentina
Research Site
Adelaide, , Australia
Research Site
Camperdown, , Australia
Research Site
Clayton, , Australia
Research Site
East Gosford, , Australia
Research Site
Elizabeth Vale, , Australia
Research Site
Fitzroy, , Australia
Research Site
Garran, , Australia
Research Site
Geelong, , Australia
Research Site
Heidelberg West, , Australia
Research Site
Meadobank, , Australia
Research Site
Milton, , Australia
Research Site
Parkville, , Australia
Research Site
Sydney, , Australia
Research Site
Feldkirch, , Austria
Research Site
Graz, , Austria
Research Site
Innsbruck, , Austria
Research Site
Salzburg, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Zams, , Austria
Research Site
Brussels, , Belgium
Research Site
Leuven, , Belgium
Research Site
Merksem, , Belgium
Research Site
Ronse, , Belgium
Research Site
Aparecida de Goiânia, , Brazil
Research Site
Belém, , Brazil
Research Site
Brasília, , Brazil
Research Site
Campinas, , Brazil
Research Site
Campinas, , Brazil
Research Site
Curitiba, , Brazil
Research Site
Curitiba, , Brazil
Research Site
Fortaleza, , Brazil
Research Site
Fortaleza, , Brazil
Research Site
Goiânia, , Brazil
Research Site
Marília, , Brazil
Research Site
Passo Fundo, , Brazil
Research Site
Recife, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Blagoevgrad, , Bulgaria
Research Site
Gabrovo, , Bulgaria
Research Site
Golenci, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sevlievo, , Bulgaria
Research Site
Sliven, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Calgary, Alberta, Canada
Research Site
Delta, British Columbia, Canada
Research Site
New Westminster, British Columbia, Canada
Research Site
Surrey, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Moncton, New Brunswick, Canada
Research Site
Bridgewater, Nova Scotia, Canada
Research Site
Liverpool, Nova Scotia, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
Guelph, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
North York, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Scarborough Village, Ontario, Canada
Research Site
Smiths Falls, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Laval, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Sainte-Foy, Quebec, Canada
Research Site
Terrebonne, Quebec, Canada
Research Site
Osorno, , Chile
Research Site
Puerto Varas, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Temuco, , Chile
Research Site
Viña del Mar, , Chile
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Chongqing, , China
Research Site
Chongqing, , China
Research Site
Chuangchun, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hong Kong, , China
Research Site
Nanjing, , China
Research Site
Nanjing, , China
Research Site
Nanning, , China
Research Site
Shanghai, , China
Research Site
Shijiazhuang, , China
Research Site
Siping, , China
Research Site
Suzhou, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Research Site
Yinchuan, , China
Research Site
Barranquilla, , Colombia
Research Site
Barranquilla, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Bogotá D.C., , Colombia
Research Site
Cali, , Colombia
Research Site
Manizales, , Colombia
Research Site
Medellín, , Colombia
Research Site
Medellín, , Colombia
Research Site
Olomouc-Lazce, , Czechia
Research Site
Prague, , Czechia
Research Site
Praha 10, Prague, , Czechia
Research Site
Svitavy, , Czechia
Research Site
Znojmo, , Czechia
Research Site
Aachen, , Germany
Research Site
Aschaffenburg, , Germany
Research Site
Bad Nauheim, , Germany
Research Site
Bad Oeynhausen, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Bochum, , Germany
Research Site
Burg, , Germany
Research Site
Burghausen, , Germany
Research Site
Chemnitz, , Germany
Research Site
Dortmund, , Germany
Research Site
Dresden, , Germany
Research Site
Dresden, , Germany
Research Site
Dresden, , Germany
Research Site
Eschweiler, , Germany
Research Site
Essen, , Germany
Research Site
Giessen, , Germany
Research Site
Herne, , Germany
Research Site
Hohenmölsen, , Germany
Research Site
Kassel, , Germany
Research Site
Kiel-Kronshagen, , Germany
Research Site
Köthen, , Germany
Research Site
Lichtenfels, , Germany
Research Site
Mainz, , Germany
Research Site
Mayen, , Germany
Research Site
München, , Germany
Research Site
München, , Germany
Research Site
Münster, , Germany
Research Site
Obermichelbach, , Germany
Research Site
Osnabrück, , Germany
Research Site
Riesa, , Germany
Research Site
Rotenburg (Wümme), , Germany
Research Site
Stuttgart, , Germany
Research Site
Würzburg, , Germany
Research Site
Hong Kong, , Hong Kong
Research Site
Shatin, , Hong Kong
Research Site
Balatonfüred, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Csongrád, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Eger, , Hungary
Research Site
Győr, , Hungary
Research Site
Hódmezővásárhely, , Hungary
Research Site
Jászberény, , Hungary
Research Site
Kaposvár, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Komárom, , Hungary
Research Site
Mosonmagyaróvár, , Hungary
Research Site
Nagykanizsa, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Pápa, , Hungary
Research Site
Pécs, , Hungary
Research Site
Sátoraljaújhely, , Hungary
Research Site
Szekszárd, , Hungary
Research Site
Szentes, , Hungary
Research Site
Szentes, , Hungary
Research Site
Székesfehérvár, , Hungary
Research Site
Szigetvár, , Hungary
Research Site
Szikszó, , Hungary
Research Site
Veszprém, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Giv‘atayim, , Israel
Research Site
Hadera, , Israel
Research Site
Hadera, , Israel
Research Site
Haifa, , Israel
Research Site
Haifa, , Israel
Research Site
Holon, , Israel
Research Site
Jerusalem, , Israel
Research Site
Jerusalem, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Nahariya, , Israel
Research Site
Nazareth, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Safed, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Florence, , Italy
Research Site
Foggia, , Italy
Research Site
Milan, , Italy
Research Site
Pisa, , Italy
Research Site
Roma, , Italy
Research Site
Sesto San Giovanni, , Italy
Research Site
Terni, , Italy
Research Site
Udine, , Italy
Research Site
Daugavpils, , Latvia
Research Site
Jelgava, , Latvia
Research Site
Kuldīga, , Latvia
Research Site
Kuldīga, , Latvia
Research Site
Ogre, , Latvia
Research Site
Riga, , Latvia
Research Site
Riga, , Latvia
Research Site
Riga, , Latvia
Research Site
Riga, , Latvia
Research Site
Talsi, , Latvia
Research Site
Tukums, , Latvia
Research Site
Kaunas, , Lithuania
Research Site
Kaunas, , Lithuania
Research Site
Kaunas, , Lithuania
Research Site
Kaunas, , Lithuania
Research Site
Kaunas, , Lithuania
Research Site
Kaunas, , Lithuania
Research Site
Kėdainiai, , Lithuania
Research Site
Klaipėda, , Lithuania
Research Site
Klaipėda, , Lithuania
Research Site
Panevezys, , Lithuania
Research Site
Ukmerge, , Lithuania
Research Site
Utena, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Alor Star, , Malaysia
Research Site
Batu Caves, , Malaysia
Research Site
Kota Samarahan, , Malaysia
Research Site
Kuala Lumpur, , Malaysia
Research Site
Kuching, , Malaysia
Research Site
Sungai Buloh, , Malaysia
Research Site
Taiping, , Malaysia
Research Site
Aguascalientes, , Mexico
Research Site
Cuautla, , Mexico
Research Site
Durango, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
México, , Mexico
Research Site
México, , Mexico
Research Site
México, , Mexico
Research Site
México, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Puebla City, , Mexico
Research Site
Querétaro, , Mexico
Research Site
San Luis Potosí City, , Mexico
Research Site
Amersfoort, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Eindhoven, , Netherlands
Research Site
Groningen, , Netherlands
Research Site
Hardenberg, , Netherlands
Research Site
Hoogeveen, , Netherlands
Research Site
Meppel, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Sneek, , Netherlands
Research Site
Utrecht, , Netherlands
Research Site
Christchurch, , New Zealand
Research Site
Christchurch, , New Zealand
Research Site
Christchurch, , New Zealand
Research Site
Hamilton, , New Zealand
Research Site
Nelson, , New Zealand
Research Site
Newtown, , New Zealand
Research Site
Palmerston North, , New Zealand
Research Site
Takapuna, , New Zealand
Research Site
Tauranga, , New Zealand
Research Site
Tauranga, , New Zealand
Research Site
Wellington, , New Zealand
Research Site
Cebu, , Philippines
Research Site
Iloilo City, , Philippines
Research Site
Manila, , Philippines
Research Site
Marikina City, , Philippines
Research Site
Pasig, , Philippines
Research Site
Quezon, , Philippines
Research Site
Quezon, , Philippines
Research Site
Quezon, , Philippines
Research Site
Quezon City, , Philippines
Research Site
San Juan City, , Philippines
Research Site
Elblag, , Poland
Research Site
Gdynia, , Poland
Research Site
Grodzisk Mazowiecki, , Poland
Research Site
Grudziądz, , Poland
Research Site
Katowice, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Ostrołęka, , Poland
Research Site
Poznan, , Poland
Research Site
Płock, , Poland
Research Site
Słupsk, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Łęczna, , Poland
Research Site
Bacau, , Romania
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Buzău, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Craiova, , Romania
Research Site
Iași, , Romania
Research Site
Oradea, , Romania
Research Site
Ploieşti, , Romania
Research Site
Satu Mare, , Romania
Research Site
Timișoara, , Romania
Research Site
Timișoara, , Romania
Research Site
Zalău, , Romania
Research Site
Kemerovo, , Russia
Research Site
Krasnoyarsk, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Peterburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
St.Рetersburg, , Russia
Research Site
Thymen, , Russia
Research Site
Tomsk, , Russia
Research Site
Tomsk, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Bardejov, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Lučenec, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Rožňava, , Slovakia
Research Site
Trebišov, , Slovakia
Research Site
Žilina, , Slovakia
Research Site
Boksburg, , South Africa
Research Site
Brits, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Centurion, , South Africa
Research Site
Durban, , South Africa
Research Site
Durban, , South Africa
Research Site
eMkhomazi, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Kempton Park, , South Africa
Research Site
Lenasia, , South Africa
Research Site
Paarl, , South Africa
Research Site
Parktown, , South Africa
Research Site
Phoenix, , South Africa
Research Site
Port Elizabeth, , South Africa
Research Site
Potchefstroom, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Somerset West, , South Africa
Research Site
Soweto, , South Africa
Research Site
Busan, , South Korea
Research Site
Daegu, , South Korea
Research Site
Daegu, , South Korea
Research Site
Daegu, , South Korea
Research Site
Gwangjin-gu, , South Korea
Research Site
Gyeonggi-do, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seongnam, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Suwon, , South Korea
Research Site
Ulsan, , South Korea
Research Site
A Coruña, , Spain
Research Site
Alcalá de Henares, , Spain
Research Site
Ávila, , Spain
Research Site
Ferrol, , Spain
Research Site
Girona, , Spain
Research Site
Granada, , Spain
Research Site
Granada, , Spain
Research Site
Lleida, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Manacor, , Spain
Research Site
Málaga, , Spain
Research Site
Palma de Mallorca, , Spain
Research Site
Palma deMallorca, , Spain
Research Site
Salamanca, , Spain
Research Site
Seville, , Spain
Research Site
Tarragona, , Spain
Research Site
Changhua, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung Hsien, , Taiwan
Research Site
Kweishan Shiang, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan County, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Chernivtsi, , Ukraine
Research Site
Dnipro, , Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Donetck, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Sumy, , Ukraine
Research Site
Ternopil, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Zaporizhia, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Research Site
Zhytomyr, , Ukraine
Research Site
Aberdeen, , United Kingdom
Research Site
Addlestone, , United Kingdom
Research Site
Birmingham, , United Kingdom
Research Site
Blackpool, , United Kingdom
Research Site
Bradford, , United Kingdom
Research Site
Bristol, , United Kingdom
Research Site
Cambridge, , United Kingdom
Research Site
Chippenham, , United Kingdom
Research Site
Coventry, , United Kingdom
Research Site
Dundee, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Hull, , United Kingdom
Research Site
Inverness, , United Kingdom
Research Site
Irvine, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Northampton, , United Kingdom
Research Site
Ormskirk, , United Kingdom
Research Site
Peterborough, , United Kingdom
Research Site
Plymouth, , United Kingdom
Research Site
Plymouth, , United Kingdom
Research Site
Redhill, , United Kingdom
Research Site
Sheffield, , United Kingdom
Research Site
Suffolk, , United Kingdom
Research Site
Swansea, , United Kingdom
Research Site
Trowbridge, , United Kingdom
Research Site
West Sussex, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Koychev I, Reid G, Nguyen M, Mentz RJ, Joyce D, Shah SH, Holman RR. Inflammatory proteins associated with Alzheimer's disease reduced by a GLP1 receptor agonist: a post hoc analysis of the EXSCEL randomized placebo controlled trial. Alzheimers Res Ther. 2024 Oct 2;16(1):212. doi: 10.1186/s13195-024-01573-x.
Gao N, Dakin HA, Holman RR, Lim LL, Leal J, Clarke P. Estimating Risk Factor Time Paths Among People with Type 2 Diabetes and QALY Gains from Risk Factor Management. Pharmacoeconomics. 2024 Sep;42(9):1017-1028. doi: 10.1007/s40273-024-01398-4. Epub 2024 Jun 26.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
d5551c00003\_bcb109\_csp\_amendment\_6\_updated\_Redacted
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MB001-002
Identifier Type: OTHER
Identifier Source: secondary_id
BCB109
Identifier Type: OTHER
Identifier Source: secondary_id
D5551C00003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.