AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3NCT01144338

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

A Phase 3 study testing Exenatide Once Weekly in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 629 sites in 35 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Exenatide Once Weekly
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14,752 participants
Where
629 sitesin 35 countries
Study dates
18 Jun 2010to 24 Apr 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

629 sites in 35 countries.

629 sites in 35 countries

United States139 sites

  • Research Site

    Albany, New York, 12203

  • Research Site

    Alexandria, Louisiana, 71301

  • Research Site

    Alpena, Michigan, 49707

  • Research Site

    Ann Arbor, Michigan, 48109

  • Research Site

    Arlington, Texas, 76012

  • Research Site

    Atlanta, Georgia, 30339

  • Research Site

    Atlanta, Georgia, 30342

  • Research Site

    Auburn, Maine, 04210

  • Research Site

    Aurora, Colorado, 80045

  • Research Site

    Avon, Indiana, 46123

  • Research Site

    Baltimore, Maryland, 21215

  • Research Site

    Barberton, Ohio, 44203

  • Research Site

    Bethlehem, Pennsylvania, 18015

  • Research Site

    Billings, Montana, 59101

  • Research Site

    Birmingham, Alabama, 35294

  • Research Site

    Bloomfield Hills, Michigan, 48302

  • Research Site

    Bridgeton, Missouri, 63044

  • Research Site

    Bristol, Tennessee, 37620

  • Research Site

    Butte, Montana, 59701

  • Research Site

    Canal Fulton, Ohio, 44614

  • Research Site

    Cape Coral, Florida, 33904

  • Research Site

    Charleston, South Carolina, 29401

  • Research Site

    Charlotte, North Carolina, 28207

  • Research Site

    Chattanooga, Tennessee, 37403

  • Research Site

    Chesterfield, Missouri, 63017

  • Research Site

    Chicago, Illinois, 60607

  • Research Site

    Chula Vista, California, 91911-1350

  • Research Site

    Cleveland, Ohio, 44121

  • Research Site

    Cleveland, Ohio, 44122

  • Research Site

    Cleveland, Ohio, 44195

  • Research Site

    Colorado Springs, Colorado, 80920

  • Research Site

    Columbus, Ohio, 43210

  • Research Site

    Concord, California, 94520

  • Research Site

    Covington, Kentucky, 41011

  • Research Site

    Dallas, Texas, 75218

  • Research Site

    Dallas, Texas, 75231

  • Research Site

    Dallas, Texas, 75251

  • Research Site

    Dallas, Texas, 75390

  • Research Site

    Decatur, Georgia, 30033

  • Research Site

    Des Moines, Iowa, 50263

  • Research Site

    Detroit, Michigan, 48201

  • Research Site

    Detroit, Michigan, 48202

  • Research Site

    Duluth, Minnesota, 55805

  • Research Site

    Durham, North Carolina, 27705

  • Research Site

    El Paso, Texas, 79925

  • Research Site

    Escondido, California, 92029

  • Research Site

    Evansville, Kentucky, 47713

  • Research Site

    Fargo, North Dakota, 58103

  • Research Site

    Feasterville, Pennsylvania, 19053

  • Research Site

    Fort Lauderdale, Florida, 33308

  • Research Site

    Friendswood, Texas, 77546

  • Research Site

    Fullerton, California, 92835

  • Research Site

    Gary, Indiana, 46403

  • Research Site

    Glendale, Arizona, 85306

  • Research Site

    Greenbrae, California, 94904

  • Research Site

    Greensboro, North Carolina, 27401

  • Research Site

    Hamilton, New Jersey, 08690

  • Research Site

    Hickory, North Carolina, 28602

  • Research Site

    Hines, Illinois, 60141

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Indianapolis, Indiana, 46260

  • Research Site

    Jackson, Tennessee, 38305

  • Research Site

    Jacksonville, Florida, 32216

  • Research Site

    Johnson City, Tennessee, 37601

  • Research Site

    Jonesboro, Arkansas, 72401

  • Research Site

    Kansas City, Kansas, 66160

  • Research Site

    Kettering, Ohio, 45429

  • Research Site

    Kingsport, Tennessee, 37660

  • Research Site

    Knoxville, Tennessee, 37912

  • Research Site

    La Mesa, California, 91942

  • Research Site

    Laguna Hills, California, 92653

  • Research Site

    Lansdale, Pennsylvania, 19446

  • Research Site

    Las Vegas, Nevada, 89121

  • Research Site

    Layton, Utah, 84041

  • Research Site

    Lexington, Kentucky, 40502

  • Research Site

    Little Rock, Arkansas, 72204

  • Research Site

    Littleton, Colorado, 80120

  • Research Site

    Long Beach, California, 90822

  • Research Site

    Los Angeles, California, 90033

  • Research Site

    Lyons, New Jersey, 07939

  • Research Site

    Manhasset, New York, 11030

  • Research Site

    Margate City, New Jersey, 08402

  • Research Site

    Marietta, Georgia, 30067

  • Research Site

    McKenzie, Tennessee, 38201

  • Research Site

    Mentor, Ohio, 44060

  • Research Site

    Minneapolis, Minnesota, 55416

  • Research Site

    Minneapolis, Minnesota, 55454

  • Research Site

    Mooresville, North Carolina, 28117

  • Research Site

    Morehead City, North Carolina, 28557

  • Research Site

    Mt. Pleasant, South Carolina, 29464

  • Research Site

    Murrells Inlet, South Carolina, 29576

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    New York, New York, 10001

  • Research Site

    New York, New York, 10032

  • Research Site

    Newport, Pennsylvania, 17011

  • Research Site

    Newport, Pennsylvania, 17074

  • Research Site

    North Massapequa, New York, 11758

  • Research Site

    Northridge, California, 91325

  • Research Site

    Oceanside, California, 92056

  • Research Site

    Oklahoma City, Oklahoma, 73103

  • Research Site

    Omaha, Nebraska, 68154

  • Research Site

    Orange, California, 92868

  • Research Site

    Pawtucket, Rhode Island, 02860

  • Research Site

    Penndel, Pennsylvania, 19047

  • Research Site

    Philadelphia, Pennsylvania, 19114

  • Research Site

    Philadelphia, Pennsylvania, 19134

  • Research Site

    Phoenix, Arizona, 85012

  • Research Site

    Pocatello, Idaho, 83201

  • Research Site

    Raleigh, North Carolina, 27609

  • Research Site

    Randallstown, Maryland, 21133

  • Research Site

    Rapid City, South Dakota, 57701

  • Research Site

    Redondo Beach, California, 90277

  • Research Site

    Reno, Nevada, 89511

  • Research Site

    Rock Island, Illinois, 61201

  • Research Site

    Rockville, Maryland, 20874

  • Research Site

    Rosedale, New York, 11422

  • Research Site

    Roswell, Georgia, 30076

  • Research Site

    Saint Cloud, Minnesota, 56303

  • Research Site

    Salisbury, North Carolina, 28144

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    San Diego, California, 92120

  • Research Site

    San Diego, California, 92161

  • Research Site

    Sarasota, Florida, 34239

  • Research Site

    Smithtown, New York, 11787

  • Research Site

    South Plainfield, New Jersey, 07080

  • Research Site

    Springfield, Illinois, 62704

  • Research Site

    Statesville, North Carolina, 28625

  • Research Site

    Sylmar, California, 91342

  • Research Site

    The Bronx, New York, 10461

  • Research Site

    Thomaston, Connecticut, 06787

  • Research Site

    Tipton, Pennsylvania, 16684

  • Research Site

    Toledo, Ohio, 43614

  • Research Site

    Torrance, California, 90505

  • Research Site

    Tustin, California, 92780

  • Research Site

    Victorville, California, 92392

  • Research Site

    Washington D.C., District of Columbia, 20037

  • Research Site

    Webster, Texas, 77598

  • Research Site

    Wilmington, North Carolina, 28401

  • Research Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany35 sites

  • Research Site

    Aachen, 52074

  • Research Site

    Aschaffenburg, 63739

  • Research Site

    Bad Nauheim, 61231

  • Research Site

    Bad Oeynhausen, 32545

  • Research Site

    Berlin, 10787

  • Research Site

    Berlin, 13125

  • Research Site

    Berlin, 13353

  • Research Site

    Bochum, 44791

  • Research Site

    Burg, 03096

  • Research Site

    Burghausen, 84489

  • Research Site

    Chemnitz, 09111

  • Research Site

    Dortmund, 44137

  • Research Site

    Dresden, 01067

  • Research Site

    Dresden, 01219

  • Research Site

    Dresden, 01307

  • Research Site

    Eschweiler, 52249

  • Research Site

    Essen, 45355

  • Research Site

    Giessen, 35392

  • Research Site

    Herne, 44653

  • Research Site

    Hohenmölsen, 06679

  • Research Site

    Kassel, 34121

  • Research Site

    Kiel-Kronshagen, 24119

  • Research Site

    Köthen, 06366

  • Research Site

    Lichtenfels, 96215

  • Research Site

    Mainz, 55116

  • Research Site

    Mayen, 56727

  • Research Site

    München, 80336

  • Research Site

    München, 81925

  • Research Site

    Münster, 48145

  • Research Site

    Obermichelbach, 90587

  • Research Site

    Osnabrück, 49080

  • Research Site

    Riesa, 01587

  • Research Site

    Rotenburg (Wümme), 36199

  • Research Site

    Stuttgart, 70376

  • Research Site

    Würzburg, 97072

Other trials in Germany

Hungary33 sites

  • Research Site

    Balatonfüred, 8230

  • Research Site

    Budapest, 1036

  • Research Site

    Budapest, 1045

  • Research Site

    Budapest, 1083

  • Research Site

    Budapest, 1085

  • Research Site

    Budapest, 1096

  • Research Site

    Budapest, 1145

  • Research Site

    Budapest, 1204

  • Research Site

    Budapest, 1213

  • Research Site

    Budapest, H-1096

  • Research Site

    Csongrád, 6640

  • Research Site

    Debrecen, 4032

  • Research Site

    Eger, 3300

  • Research Site

    Győr, 9023

  • Research Site

    Hódmezővásárhely, 6800

  • Research Site

    Jászberény, 5100

  • Research Site

    Kaposvár, 7400

  • Research Site

    Kecskemét, 6000

  • Research Site

    Komárom, 2921

  • Research Site

    Mosonmagyaróvár, H-9200

  • Research Site

    Nagykanizsa, 8800

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Pápa, 8500

  • Research Site

    Pécs, 7624

  • Research Site

    Sátoraljaújhely, 3980

  • Research Site

    Székesfehérvár, 8000

  • Research Site

    Szekszárd, 7100

  • Research Site

    Szentes, 6600

  • Research Site

    Szentes, H-6600

  • Research Site

    Szigetvár, 7900

  • Research Site

    Szikszó, 3800

  • Research Site

    Veszprém, 8200

  • Research Site

    Zalaegerszeg, 8900

Other trials in Hungary

United Kingdom29 sites

  • Research Site

    Aberdeen, AB25 2ZD

  • Research Site

    Addlestone, KT15 2BH

  • Research Site

    Birmingham, B9 5SS

  • Research Site

    Blackpool, FY4 3AD

  • Research Site

    Bradford, BD9 6RJ

  • Research Site

    Bristol, BS10 5NB

  • Research Site

    Cambridge, CB2 0QQ

  • Research Site

    Chippenham, SN14 6GT

  • Research Site

    Coventry, CV2 2DX

  • Research Site

    Dundee, DD1 9SY

  • Research Site

    Edinburgh, EH4 2XU

  • Research Site

    Glasgow, G12 8TA

  • Research Site

    Hull, HU3 2JZ

  • Research Site

    Inverness, IV2 3JH

  • Research Site

    Irvine, KA12 0AY

  • Research Site

    Leicester, LE5 4PW

  • Research Site

    Liverpool, L7 8XP

  • Research Site

    Manchester, M8 5RB

  • Research Site

    Northampton, NN1 5BD

  • Research Site

    Ormskirk, L39 2AZ

  • Research Site

    Peterborough, PE8 6PL

  • Research Site

    Plymouth, PL5 3JB

  • Research Site

    Plymouth, PL6 8BX

  • Research Site

    Redhill, RH1 5RH

  • Research Site

    Sheffield, S5 7AU

  • Research Site

    Suffolk, IP33 2QZ

  • Research Site

    Swansea, SN6 6NL

  • Research Site

    Trowbridge, BA14 8QA

  • Research Site

    West Sussex, RH10 7DX

Other trials in United Kingdom

Canada28 sites

  • Research Site

    Bridgewater, Nova Scotia, B4V 3N2

  • Research Site

    Calgary, Alberta, T2T 5C7

  • Research Site

    Cambridge, Ontario, N1R 6V6

  • Research Site

    Delta, British Columbia, V4K 2K5

  • Research Site

    Guelph, Ontario, N1H 1B1

  • Research Site

    Hamilton, Ontario, L8L 5G8

  • Research Site

    Hamilton, Ontario, L8M 1K7

  • Research Site

    Hamilton, Ontario, L8N 3Z5

  • Research Site

    Kitchener, Ontario, N2M 5N6

  • Research Site

    Laval, Quebec, H7T 2P5

  • Research Site

    Liverpool, Nova Scotia, B0T 1K0

  • Research Site

    London, Ontario, N6B 2E5

  • Research Site

    Moncton, New Brunswick, E1G 1A7

  • Research Site

    Montreal, Quebec, H1M 1B1

  • Research Site

    Montreal, Quebec, H3A 1A1

  • Research Site

    New Westminster, British Columbia, V3L 3W4

  • Research Site

    North York, Ontario, M3M 3E5

  • Research Site

    Ottawa, Ontario, K1H 1A2

  • Research Site

    Sainte-Foy, Quebec, G1V 4G5

  • Research Site

    Scarborough Village, Ontario, M1E 5E9

  • Research Site

    Smiths Falls, Ontario, K7A 4W8

  • Research Site

    Surrey, British Columbia, V3V 0C6

  • Research Site

    Terrebonne, Quebec, J6V 1S8

  • Research Site

    Toronto, Ontario, M5C 2T2

  • Research Site

    Toronto, Ontario, M5T 3L9

  • Research Site

    Vancouver, British Columbia, V5Z 1M9

  • Research Site

    Winnipeg, Manitoba, R2H 0R8

  • Research Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Ukraine24 sites

  • Research Site

    Chernivtsi, 58022

  • Research Site

    Dnipro, 49006

  • Research Site

    Dnipropetrovsk, 49027

  • Research Site

    Donetck, 83045

  • Research Site

    Donetsk, 83059

  • Research Site

    Donetsk, 83114

  • Research Site

    Ivano-Frankivsk, 76000

  • Research Site

    Kharkiv, 61029

  • Research Site

    Kharkiv, 61037

  • Research Site

    Kharkiv, 61039

  • Research Site

    Kharkiv, 61178

  • Research Site

    Kiev, 04114

  • Research Site

    Kiev, 07050

  • Research Site

    Kyiv, 2091

  • Research Site

    Kyiv, 3680

  • Research Site

    Odesa, 65025

  • Research Site

    Odesa, 65114

  • Research Site

    Sumy, 40022

  • Research Site

    Ternopil, 46002

  • Research Site

    Uzhhorod, 88014

  • Research Site

    Vinnytsia, 21010

  • Research Site

    Zaporizhia, 69001

  • Research Site

    Zaporizhzhya, 69118

  • Research Site

    Zhytomyr, 10002

Other trials in Ukraine

China22 sites

  • Research Site

    Beijing, 100029

  • Research Site

    Beijing, 100034

  • Research Site

    Beijing, 100044

  • Research Site

    Beijing, 100853

  • Research Site

    Chongqing, 400010

  • Research Site

    Chongqing, 400016

  • Research Site

    Chuangchun, 130012

  • Research Site

    Guangzhou, 510080

  • Research Site

    Guangzhou, 510120

  • Research Site

    Hangzhou, 310009

  • Research Site

    Hong Kong

  • Research Site

    Nanjing, 210012

  • Research Site

    Nanjing, 210029

  • Research Site

    Nanning, 530021

  • Research Site

    Shanghai, 200072

  • Research Site

    Shijiazhuang, 050000

  • Research Site

    Siping, 136000

  • Research Site

    Suzhou, 215004

  • Research Site

    Wenzhou

  • Research Site

    Wuhan, 430000

  • Research Site

    Xi'an, 710061

  • Research Site

    Yinchuan, 750004

Other trials in China

South Africa22 sites

  • Research Site

    Boksburg, 1459

  • Research Site

    Brits, 0250

  • Research Site

    Cape Town, 7460

  • Research Site

    Cape Town, 7500

  • Research Site

    Cape Town, 7700

  • Research Site

    Centurion, 0157

  • Research Site

    Durban, 4001

  • Research Site

    Durban, 4052

  • Research Site

    eMkhomazi, 4170

  • Research Site

    Johannesburg, 2198

  • Research Site

    Kempton Park, 1619

  • Research Site

    Lenasia, 1827

  • Research Site

    Paarl, 7646

  • Research Site

    Parktown, 2193

  • Research Site

    Phoenix, 4068

  • Research Site

    Port Elizabeth, 6014

  • Research Site

    Potchefstroom, 2531

  • Research Site

    Pretoria, 0001

  • Research Site

    Pretoria, 0014

  • Research Site

    Pretoria, 0101

  • Research Site

    Somerset West, 7130

  • Research Site

    Soweto, 2013

Other trials in South Africa

Spain19 sites

  • Research Site

    A Coruña, 15006

  • Research Site

    Alcalá de Henares, 28805

  • Research Site

    Ávila, 05004

  • Research Site

    Ferrol, 15405

  • Research Site

    Girona, 17007

  • Research Site

    Granada, 18004

  • Research Site

    Granada, 18012

  • Research Site

    Lleida, 25198

  • Research Site

    Madrid, 28007

  • Research Site

    Madrid, 28034

  • Research Site

    Madrid, 28046

  • Research Site

    Madrid, 28702

  • Research Site

    Málaga, 29006

  • Research Site

    Manacor, 07500

  • Research Site

    Palma de Mallorca, 07198

  • Research Site

    Palma deMallorca, 07010

  • Research Site

    Salamanca, 37003

  • Research Site

    Seville, 41010

  • Research Site

    Tarragona, 43007

Other trials in Spain

Argentina18 sites

  • Research Site

    Buenos Aires, C1425AGC

  • Research Site

    Buenos Aires, C1437BZL

  • Research Site

    CABA, 1426

  • Research Site

    CABA, C1119ACN

  • Research Site

    CABA, C1120AAC

  • Research Site

    Capital Federal, C1425DES

  • Research Site

    CiudadAutonoma de Buenos Aires, C1419AHL

  • Research Site

    Córdoba, 5000

  • Research Site

    Córdoba, X5003DCE

  • Research Site

    Córdoba, X5004FHP

  • Research Site

    Córdoba, X5008HHW

  • Research Site

    Godoy Cruz, M5501ARP

  • Research Site

    Mar Del Plata Buenos Aires, B7600DIA

  • Research Site

    Rosario, S2000CVD

  • Research Site

    Salta, A4400ANG

  • Research Site

    San Miguel de Tucumán, 4000

  • Research Site

    San Salvador de Jujuy

  • Research Site

    Santa Rosa

Other trials in Argentina

Romania17 sites

  • Research Site

    Bacau, 600164

  • Research Site

    Bucharest, 010507

  • Research Site

    Bucharest, 010627

  • Research Site

    Bucharest, 020725

  • Research Site

    Bucharest, 030306

  • Research Site

    Bucharest, 042122

  • Research Site

    Buzău, 120203

  • Research Site

    Cluj-Napoca, 400006

  • Research Site

    Cluj-Napoca, 400349

  • Research Site

    Craiova, 200147

  • Research Site

    Iași, 700111

  • Research Site

    Oradea, 410169

  • Research Site

    Ploieşti, 100477

  • Research Site

    Satu Mare, 440055

  • Research Site

    Timișoara, 300125

  • Research Site

    Timișoara, 300456

  • Research Site

    Zalău, 450129

Other trials in Romania

Poland16 sites

  • Research Site

    Elblag, 82-300

  • Research Site

    Gdynia, 81-472

  • Research Site

    Grodzisk Mazowiecki, 05-825

  • Research Site

    Grudziądz, 86-300

  • Research Site

    Katowice, 40-752

  • Research Site

    Łęczna, 21-010

  • Research Site

    Lodz, 94-074

  • Research Site

    Lublin, 20-090

  • Research Site

    Ostrołęka, 07-400

  • Research Site

    Płock, 09-402

  • Research Site

    Poznan, 60-659

  • Research Site

    Słupsk, 76-200

  • Research Site

    Warsaw, 04-635

  • Research Site

    Wroclaw, 50-127

  • Research Site

    Wroclaw, 50-403

  • Research Site

    Wroclaw, 51-124

Other trials in Poland

South Korea16 sites

  • Research Site

    Busan, 49241

  • Research Site

    Daegu, 41931

  • Research Site

    Daegu, 700-721

  • Research Site

    Daegu, 705-718

  • Research Site

    Gwangjin-gu, 110-744

  • Research Site

    Gyeonggi-do, 411-706

  • Research Site

    Incheon, 403-720

  • Research Site

    Seongnam, 463-707

  • Research Site

    Seoul, 08308

  • Research Site

    Seoul, 110746

  • Research Site

    Seoul, 134-727

  • Research Site

    Seoul, 135-720

  • Research Site

    Seoul, 137-701

  • Research Site

    Suwon, 16247

  • Research Site

    Suwon, 443-721

  • Research Site

    Ulsan, 682-714

Other trials in South Korea

Brazil15 sites

  • Research Site

    Aparecida de Goiânia, 74905-350

  • Research Site

    Belém, 66073-000

  • Research Site

    Brasília, 71625-175

  • Research Site

    Campinas, 13010-001

  • Research Site

    Campinas, 13060-904

  • Research Site

    Curitiba, 80060-900

  • Research Site

    Curitiba, 80730-150

  • Research Site

    Fortaleza, 60115282

  • Research Site

    Fortaleza, 60430-350

  • Research Site

    Goiânia, 74125-170

  • Research Site

    Marília, 17515-460

  • Research Site

    Passo Fundo, 99010-080

  • Research Site

    Recife, 52020010

  • Research Site

    São Paulo, 01244-030

  • Research Site

    São Paulo, 04022001

Other trials in Brazil

Israel15 sites

  • Research Site

    Giv‘atayim, 53583

  • Research Site

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Mexico12 sites

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Netherlands10 sites

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Taiwan10 sites

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About this study

Official title: 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.

Being tested
Exenatide Once Weekly, Placebo
Keywords
exenatide once weekly, cardiovascular, Bydureon, Amylin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exenatide Once WeeklyDrug

    Subcutaneous injection, 2 mg, administered once weekly.

  • PlaceboDrug

    Subcutaneous injection, matching volume of placebo, administered once weekly.

Study groups in NCT01144338
Study groupRoleWhat they receive
Exenatide Once WeeklyExperimentalNot described
Receives: Drug: Exenatide Once Weekly
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

  2. 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.

    Measured: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Secondary outcomes (6)

  1. 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.

    Measured: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

  2. 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.

    Measured: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

  3. 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.

    Measured: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

  4. 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.

    Measured: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

  5. 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.

    Measured: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

  6. 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.

    Measured: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2010 (estimated)
  2. Study start18 Jun 2010
  3. Primary completion21 Apr 2017
  4. Study completion24 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
14,752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144338
Sponsor's protocol ID
D5551C00003
Other IDs
MB001-002, BCB109
Status last verified
Jul 2018
First submitted
10 Jun 2010
Last updated
8 Aug 2018
Data monitoring committee
Yes

Publications

  • Umapathysivam MM, Araldi E, Hastoy B, Dawed AY, Vatandaslar H, Mayrhofer JE, Lindquist P, Silva PN, Goga A, Trullinger GO, Godbersen S, Sengupta S, Kaufmann A, Thomsen SK, Hartmann B, Chen YC, Jonsson AE, Kabakci H, Thaman S, Grarup N, Have CT, Pallo LP, Faerch K, Gjesing AP, Nawaz S, Cheeseman J, Neville MJ, Pedersen O, Walker M, Sun H, Jennison C, Hattersley AT, Rehfeld JF, Holman RR, Verchere BC, Hansen T, Karpe F, Holst JJ, Rosenkilde MM, Jones AG, Ristow M, McCarthy MI, Pearson ER, Stoffel M, Gloyn AL. Type 2 diabetes risk alleles in peptidyl-glycine alpha-amidating monooxygenase influence GLP-1 levels and response to GLP-1 receptor agonists. Genome Med. 2026 Mar 29;18(1):40. doi: 10.1186/s13073-026-01630-0.

    PubMed 41906117

  • 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.

    PubMed 39963952

  • 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.

    PubMed 39358806

  • Oulhaj A, Aziz F, Suliman A, Eller K, Bentoumi R, Buse JB, Al Mahmeed W, von Lewinski D, Coleman RL, Holman RR, Sourij H. Estimated glomerular filtration rate slope and risk of primary and secondary major adverse cardiovascular events and heart failure hospitalization in people with type 2 diabetes: An analysis of the EXSCEL trial. Diabetes Obes Metab. 2024 Oct;26(10):4602-4612. doi: 10.1111/dom.15817. Epub 2024 Jul 31.

    PubMed 39086032

  • 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.

    PubMed 38922488

  • 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.

    PubMed 35761271

  • 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.

    PubMed 34813910

  • 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.

    PubMed 32098501

  • 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.

    PubMed 31882409

  • 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.

    PubMed 31806653

  • 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.

    PubMed 31752517

  • 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.

    PubMed 31640705

  • 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.

    PubMed 31542942

  • 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.

    PubMed 31010875

  • 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.

    PubMed 30371301

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exenatide Once Weekly in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 629 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 629 sites in United States, Germany, Hungary, United Kingdom, Canada and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Outcome MACE Events (time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01144338, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.

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