Type 2 Diabetes MellitusPhase 3SURPASS-CVOTNCT04255433
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
A Phase 3 study testing Tirzepatide and Dulaglutide in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 635 sites in 31 countries.
Trial summary
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Tirzepatide and Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,299 participants
- Where
- 635 sitesin 31 countries
- Study dates
- 29 May 2020to 12 Jun 2025
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 40 years old with a diagnosis of type 2 diabetes
- Established cardiovascular disease, including at least 1 of the following:
- Coronary artery disease (CAD) with any of the following:
- Documented history of spontaneous myocardial infarction (MI)
- ≥50% stenosis in 1 or more major coronary arteries, determined by invasive angiography
- ≥50% stenosis in 2 or more major coronary arteries, determined by computed tomography coronary angiography (CTCA)
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- History of surgical or percutaneous coronary revascularization procedure
- Cerebrovascular disease - any of the following:
- Documented history of ischemic stroke
- Carotid arterial disease with ≥50% stenosis, documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography
- Carotid stenting or surgical revascularization
- Peripheral arterial disease with either of the following:
- Intermittent claudication and ankle-brachial index <0.9
- Prior nontraumatic amputation or peripheral vascular procedure (eg, stenting or surgical revascularization), due to peripheral arterial ischemia
- Note: Supporting medical documentation is required in all instances
- HbA1c ≥7% (≥53 mmol/mol) and ≤10.5% (≤91.3 mmol/mol) based on central laboratory assessment at screening
- Body mass index (BMI) ≥25 kg/m2
- At the time of signing the informed consent: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
- Male patients: Men, regardless of their fertility status, with nonpregnant women of childbearing potential (WOCBP) partners must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms, as well as 1 additional highly effective (less than 1% failure rate) method of contraception (such as combination oral contraceptives, implanted contraceptives, or intrauterine devices) or effective method of contraception (such as diaphragms with spermicide or cervical sponges) for the duration of the study and until their plasma concentrations are below the level that could result in a relevant potential exposure to a possible fetus, predicted to be 90 days following the last dose of study drug.
- Men and their partners may choose to use a double-barrier method of contraception. (Barrier protection methods without concomitant use of a spermicide are not an effective or acceptable method of contraception. Thus, each barrier method must include use of a spermicide. It should be noted, however, that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these barrier methods are combined).
- Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
- Men with pregnant partners should use condoms during intercourse for the duration of the study and until the end of the estimated relevant potential exposure in WOCBP (90 days). Men should refrain from sperm donation for the duration of the study and until their plasma concentrations are below the level that could result in a relevant potential exposure to a possible fetus, predicted to be 90 days following the last dose of study drug. Men who are in exclusively same-sex relationships (as their preferred and usual lifestyle) are not required to use contraception.
- Female patients: Women of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with males. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception. Otherwise, WOCBP participating must agree to use 2 forms of effective contraception, where at least 1 form is highly effective (less than 1% failure rate), for the entirety of the study. Contraception must continue following completion of study drug administration for the entirety of the study and for 30 days thereafter.
- WOCBP participating must test negative for pregnancy prior to initiation of treatment as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to exposure.
- Two forms of effective contraception, where at least 1 form is highly effective, (such as combination oral contraceptives, implanted contraceptives, or intrauterine devices) will be used. Effective contraception (such as male or female condoms with spermicide, diaphragms with spermicide, or cervical sponges) may be used as the second therapy. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide (ie, condom with spermicide, diaphragm with spermicide, or female condom with spermicide). It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined.
- Women not of childbearing potential may participate and include those who are:
- infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis, or
- postmenopausal - defined as either: A woman at least 40 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, AND a follicle-stimulating hormone >40 mIU/mL; or ii. A woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea; or A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy.
- In the investigator's opinion, are well motivated, capable, and willing to:
- learn how to self-inject treatment (tirzepatide or dulaglutide), as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study drug),
- inject study drug weekly,
- have a sufficient understanding of 1 of the provided languages of the country such that they will be able to complete the patient questionnaires, and
- make themselves available for the duration of the study, and who will comply with the required study visits.
- Capable of giving signed informed consent
Who cannot join
- Have type 1 diabetes mellitus
- Have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the physician
- Have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to screening
- Are currently planning treatment for diabetic retinopathy and/or macular edema.
- Have been hospitalized for congestive heart failure (CHF) within 2 months prior to screening
- Have chronic New York Heart Association Functional Classification IV CHF
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- Are currently planning a coronary, carotid, or peripheral artery revascularization
- Had chronic or acute pancreatitis any time prior to screening, irrespective of etiology
- Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
- Have acute or chronic hepatitis, signs or symptoms of any other liver disease, an alanine aminotransferase (ALT) level ≥3 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory (Note: Patients with nonalcoholic fatty liver disease are eligible to participate if their ALT level is <3 times the ULN for the reference range)
- Have known chronic severe renal failure (defined as a known estimated glomerular filtration rate (eGFR) <15 mL/minute/1.73 m2) or are on chronic dialysis
- Have evidence of a significant, uncontrolled endocrine abnormality (eg, thyrotoxicosis or adrenal crises)
- Have a family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (MTC) or personal history of nonfamilial MTC
- Have a serum calcitonin level at screening of: (based on central laboratory results)
- ≥20 ng/L at Visit 1, if eGFR ≥60 mL/min/1.73 m2, or
- ≥35 ng/L at Visit 1, if eGFR <60 mL/min/1.73 m2
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years. An exception for this criterion is basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer
- Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, may preclude the patient from following and completing the protocol
- Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an organ transplant
- Have any other condition (eg, hypersensitivity) that is a contraindication to any incretin or glucagon-like peptide-1 (GLP-1) receptor agonist (RA)
- Have had an MI, percutaneous coronary revascularization procedure, ischemic stroke, carotid stenting or surgical revascularization, nontraumatic amputation, or peripheral vascular procedure (eg, stenting or surgical revascularization) less than 60 days prior to screening
- Have had coronary artery bypass graft surgery less than 5 years prior to screening
- Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement
- Treatment with GLP-1 RA or pramlintide, in a period of 3 months prior to Visit 1
- Discontinuation of GLP-1 RA or pramlintide, due to intolerability any time prior to Visit 1
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- Have participated within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
- Have previously completed or withdrawn from this study or randomized into any other study investigating tirzepatide
Trial locations and contacts
635 sites in 31 countries.
635 sites in 31 countries
United States121 sites
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203
Orlando Heart & Vascular Institute, LLC
Altamonte Springs, Florida, 32714
Northwest Heart Clinical Research
Arlington Heights, Illinois, 60005
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009
Billings Clinic
Billings, Montana, 59101
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35294-0012
Elite Clinical Trials
Blackfoot, Idaho, 83221
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts, 02115
Joslin Diabetes Center
Boston, Massachusetts, 02215
Qualmedica Research
Bowling Green, Kentucky, 42101
Holston Medical Group
Bristol, Tennessee, 37620
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
Atrium Health - Department of Family Medicine Research
Charlotte, North Carolina, 28207
Cedar-Crosse Research Center
Chicago, Illinois, 60607
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
John Muir Medical Center - Concord Campus
Concord, California, 94520
Private Practice - Dr. Osvaldo A. Brusco
Corpus Christi, Texas, 78414
Valley Clinical Trials, Inc.
Covina, California, 91723
Dallas Diabetes Research Center
Dallas, Texas, 75230
North Texas Endocrine Center
Dallas, Texas, 75231
Research Institute of Dallas
Dallas, Texas, 75231
Texas Health Physicians Group
Dallas, Texas, 75231
Galenos Research
Dallas, Texas, 75251
Physicians' Research Options
Draper, Utah, 84020
Kaiser Permanente - Dutluth, GA
Duluth, Georgia, 30096
Duke University
Durham, North Carolina, 27710
St. John's Hospital
Edina, Minnesota, 55435
Academy of Diabetes, Thyroid and Endocrine
El Paso, Texas, 79935
AMCR Institute
Escondido, California, 92025
The University of Kansas - Clinical Research Center
Fairway, Kansas, 66205
Virginia Heart
Falls Church, Virginia, 22042
Lillestol Research
Fargo, North Dakota, 58104
Decpa, Llc
Feasterville, Pennsylvania, 19053
Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas, 76132
Valley Research
Fresno, California, 93720
NorCal Medical Research, Inc
Greenbrae, California, 94904
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
Clinical Investigation Specialists
Gurnee, Illinois, 60031
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517
Encore Medical Research
Hollywood, Florida, 33024
East-West Medical Research Institute
Honolulu, Hawaii, 96814
VA Pacific Islands Health Care System
Honolulu, Hawaii, 96819
Northwest Houston Cardiology - Cypress
Houston, Texas, 77070
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, 20782
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
University of Iowa
Iowa City, Iowa, 52242
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
NSC Research
Johns Creek, Georgia, 30024
Clinical Investigation Specialists
Kenosha, Wisconsin, 53144
PMG Research, Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee, 37938
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037
First Valley Medical Group
Lancaster, California, 93534
Accel Research Sites - St. Pete-Largo Clinical Research Unit
Largo, Florida, 33777
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
Palm Research Center Sunset
Las Vegas, Nevada, 89148
Physicians Research Associates
Lawrenceville, Georgia, 30045
L-MARC Research Center
Louisville, Kentucky, 40213
East Coast Institute for Research at The Jones Center
Macon, Georgia, 31210
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
Endocrine Clinic
Memphis, Tennessee, 38119
Southern Endocrinology Associates
Mesquite, Texas, 75149
ActivMed Practices and Research
Methuen, Massachusetts, 01844
Monterey Endocrine & Diabetes Institute, Inc.
Monterey, California, 93940
PMG Research Inc., d/b/a PMG of Piedmont Healthcare
Mooresville, North Carolina, 28117
Riverside University Health System - Medical Center
Moreno Valley, California, 92555
Accellacare - Mt Pleasant
Mt. Pleasant, South Carolina, 29464
Southern Nh Diabetes and Endocrinology
Nashua, New Hampshire, 03060
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
Infinity Medical Research
North Dartmouth, Massachusetts, 02747
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, 76180
Ocala Caridovascular Research
Ocala, Florida, 34474
Advanced Research Institute
Ogden, Utah, 84405
VA Nebraska-Western Iowa Health Care System
Omaha, Nebraska, 68105
University Of Nebraska Medical Center
Omaha, Nebraska, 68198-4130
Diabetes Associates Medical Group
Orange, California, 92868
Qualmedica Research, LLC
Owensboro, Kentucky, 42301
MD Medical Research
Oxon Hill, Maryland, 20745
Cardiology Partners Clinical Research Institute - Palm Beach Gardens
Palm Beach Gardens, Florida, 33410
Pasadena Clinical Research
Pasadena, California, 91105
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
Northeast Endocrine Metabolic Associates
Philadelphia, Pennsylvania, 19114
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, 15236
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
Alpine Medical Group
Salt Lake City, Utah, 84102
Audie L Murphy VA Hospital
San Antonio, Texas, 75231
LCGK Research
San Carlos, California, 94070
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583
VA Puget Sound Health Care System
Seattle, Washington, 98108
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Multicare Institute for Research and Innovation
Spokane, Washington, 99202
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, 62711
Clinvest Research LLC
Springfield, Missouri, 65807
Mercy Research - Smith Glynn Callaway
Springfield, Missouri, 65807
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713
Northwest Houston Heart Center
Tomball, Texas, 77375
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
Cotton O'Neil Mulvane
Topeka, Kansas, 66606
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
Atlanta Heart Specialists
Tucker, Georgia, 30084
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Cardiology Partners Clinical Research Institute - Wellington
Wellington, Florida, 33449
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
Kalo Clinical Research
West Valley City, Utah, 84120
Great Lakes Medical Research, LLC
Westfield, New York, 14787
Accellacare - Wilmington
Wilmington, North Carolina, 24801
Clinical Research of Central Florida
Winter Haven, Florida, 33880
Cardiology Consultants of Philadelphia Yardley
Yardley, Pennsylvania, 19067
Germany47 sites
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545
CIMS Studienzentrum Bamberg
Bamberg, Bavaria, 96049
Institut für klinische Forschung und Entwicklung
Berlin, 10437
Diabetespraxis Prenzlauer Alle
Berlin, 13187
Diabetes- und Stoffwechselpraxis Bochum
Bochum, North Rhine-Westphalia, 44869
Gemeinschaftspraxis Dres. Jung
Deggingen, Baden-Wurttemberg, 73326
Private Practice - Dr. Claus Busch, Dr. Christian Busch & Dr. Christopher Cramer
Dortmund, North Rhine-Westphalia, 44137
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
Dresden, Saxony, 1277
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 1307
Gemeinschaftspraxis für Diabetologie
Eisenach, Thuringia, 99817
ZKS Suedbrandenburg
Elsterwerda, Brandenburg, 04910
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136
Medizentrum Essen Borbeck
Essen, North Rhine-Westphalia, 45355
Private Practice - Dr. Bernd Becker
Essen, North Rhine-Westphalia, 45355
ZKS Dr. Lüdemann
Falkensee, Brandenburg, 14612
ClinPhenomics GmbH & Co KG
Frankfurt am Main, Hesse, 60596
Practice Dr.med. Denger and Dr.med. Pfitzner
Friedrichsthal, Saarland, 66299
MVZ im Altstadt-Carree Fulda GmbH
Fulda, Hesse, 36037
Diabetes Zentrum Dr. Tews
Gelnhausen, Hesse, 63571
Diabetologische Schwerpunktpraxis Harburg
Hamburg, 21073
Diabetes Zentrum Wilhelmsburg
Hamburg, 21109
Diabeteszentrum Hamburg West
Hamburg, 22607
St. Josefskrankenhaus Heidelberg
Heidelberg, 69115
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
Hohenmölsen, Saxony-Anhalt, 06679
Velocity Clinical Research Leipzig GmbH
Leipzig, Saxony, 04177
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
Leipzig, Saxony, 04249
AmBeNet GmbH
Leipzig, Saxony, 4107
Private Practice - Dr. Ilka Simon-Wagner
Lichtenfels, Bavaria, 96215
Universität zu Lübeck - Institut für Endokrinologie und Diabetes
Lübeck, Schleswig-Holstein, 23562
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
Ludwigshafen am Rhein, Rhineland-Palatinate, 67059
Praxis Oedeme
Lüneburg, Lower Saxony, 21339
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, 39120
CDG Studienambulanz Hartard
München, Bavaria, 80809
Institut für Diabetesforschung GmbH Münster
Münster, North Rhine-Westphalia, 48145
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758
Private Practice - Dr. Christine Kosch
Pirna, Saxony, 1796
Diabetologische Schwerpunktpraxis Marck Linn Pickel
Pohlheim, Hesse, 35415
Praxis Dr. Veronika Wenzl-Bauer
Rehlingen, Lower Saxony, 66780
Private Practice - Dr. Joachim Weimer
Reinfeld, Schleswig-Holstein, 23858
MVZ Riesa am Klinikum Döbeln GmbH
Riesa, Saxony, 1589
Zentrum für klinische Studien
Saint Ingbert, Saarland, 66386
Medizinisches Versorgungszentrum am Bahnhof Spandau
Spandau, State of Berlin, 13597
Diabetologische Schwerpunktpraxis Diabetologikum Speyer
Speyer, Rhineland-Palatinate, 67346
Marienhospital Stuttgart
Stuttgart, Baden-Wurttemberg, 70199
Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob
Villingen-Schwenningen, Baden-Wurttemberg, 78048
Praxis Sauter & Sauter & Vorbach
Wangen, Baden-Wurttemberg, 88239
Praxis für Inner Medizin - Diabetologische Schwerpunktpraxis
Zwenkau, Saxony, 04442
Argentina31 sites
Instituto de Investigaciones Clínicas Bahia Blanca
Bahía Blanca, Buenos Aires, 8000
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., C1128AAF
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Buenos Aires F.D., C1425AGC
CEMEDIC
Buenos Aires, 1407
Glenny Corp
Buenos Aires, 1430
CIPREC
Buenos Aires, C1061
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, C1419AHN
CEMEDIAB
C.a.b.a., Buenos Aires F.D., C1205AAO
Organizacion Medica de Investigacion
CABA, Buenos Aires, C1015
CEDIC
CABA, Buenos Aires, C1060ABN
Centro Medico Privado CEMAIC
Capital, Córdoba Province, X5008HHW
Stat Research S.A.
Capital Federal, Buenos Aires, 1023
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056ABI
Centro Medico Privado San Vicente Diabetes
Córdoba, Córdoba Province, 5006
CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani
Córdoba, X5000AVE
Centro Diabetológico Dr. Waitman
Córdoba, X5000JJS
Centro Universitario de Investigación en Farmacologia Clínic
Corrientes, 3400
Instituto de Cardiología "Juana F. Cabral"
Corrientes, 3400
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, 7600
DIM Clínica Privada
Ramos Mejía, Buenos Aires, 1704
Instituto Médico Catamarca IMEC
Rosario, Santa Fe Province, 2000
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Santa Fe Province, 2000
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe Province, S2000CVD
Instituto Médico Alas
Salta, 4400
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, T4000AXL
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, 4000
Investigaciones Clínicas Tucumán
San Miguel de Tucumán, Tucumán Province, 4000
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, 2900
Sanatorio Norte
Santiago del Estero, 4200
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, B2800DGH
Canada29 sites
LMC Clinical Research Inc. (Barrie)
Barrie, Ontario, L4N 7L3
LMC Diabetes & Endocrinology
Brampton, Ontario, L6S 0C9
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
LMC Diabetes & Endocrinology
Calgary, Alberta, T2H 2G4
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6
LMC Clinical Research Inc. (Thornhill)
Concord, Ontario, L4K 4M2
Janik Research Corporation
Greater Sudbury, Ontario, P3C 1S8
Viacar Recherche Clinique
Greenfield Park, Quebec, J4V 2G8
NSHA-QEII Health Sciences Centre-Dickson Bldg
Halifax, Nova Scotia, B3H 1V7
Centre de Recherche Clinique de Laval
Laval, Quebec, H7T 2P5
Manna Research
Lévis, Quebec, G6W 0M5
Milestone Research Inc.
London, Ontario, N5W 6A2
St. Joseph's Health Care
London, Ontario, N6A 4V2
Clinique Sante Cardio MC
Montreal, Quebec, H1T 3Y7
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7
LMC Clinical Research Inc. (Oakville)
Oakville, Ontario, L6M 1M1
Private Practice - Dr. James Cha
Oshawa, Ontario, L1G 2K1
LMC Manna Research
Ottawa, Ontario, K2J 0V2
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
Diex Recherche Quebec
Québec, G1V 4T3
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3
Diabetes Clinic
Smiths Falls, Ontario, K7A 4W8
Canadian Phase Onward
Toronto, Ontario, M3J 0K2
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, M4G 3E8
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
BC Diabetes Office
Vancouver, British Columbia, V5Y 3W2
Dr. M.B. Jones Inc.
Victoria, British Columbia, V8V 4A1
Winnipeg Clinic
Winnipeg, Manitoba, MB R3C 0N2
Mexico24 sites
Centro de Investigacion Medica Aguascalientes
Aguascalientes, 20116
Fundación Cardiovascular de Aguascalientes A.C.
Aguascalientes, 20230
Hospital Cardiologica Aguescalientes
Aguascalientes, 20230
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
Chihuahua City, 31110
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, 89440
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, Morelos, 62250
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, Sinaloa, 80230
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
Durango, 34000
Diseno y Planeacion en Investigacion Medica
Guadalajara, Jalisco, 44130
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
Guadalajara, Jalisco, 44150
Centro de Investigacion Medica Integral
Guadalajara, Jalisco, 44160
Centro de Investigacion Medica de Occidente, S.C.
Guadalajara, Jalisco, 44260
Universidad de Guadalajara
Guadalajara, Jalisco, 44340
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, Jalisco, 4460
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, 44670
Salud Cardiovascular
Guadalajara, Jalisco, 44860
Medical Care and Research SA de CV
Mérida, Yucatán, 97070
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, 11650
Cardiolink Clin Trials
Monterrey, Nuevo León, 64060
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro, 76000
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Nuevo León, 66465
Centro de Investigacion Cardiovascular y Metabólica
Tijuana, Estado de Baja California, 22500
Hospital Angeles Xalapa
Xalapa, Veracruz, 91193
China23 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Peking University People's Hospital
Beijing, Beijing Municipality, 100034
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
China-Japan Union Hospital
Changchun, Jilin, 130033
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
First Huai'an Hospital Affiliated to Nanjing Medical University
Huai'an, Jiangsu, 223300
Jinan Central Hospital
Jinan, Shandong, 250013
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Lanzhou university second hospital
Lanzhou, Gansu, 730030
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Nanjing First Hospital
Nanjing, Jiangsu, 210012
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110016
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000
Israel23 sites
Emek Medical Center
Afula, Northern District, 1834111
Barzilai Medical Center
Ashkelon, Southern District, 7830604
Clalit Health Services - Atlit
Atlit, Ḥeifā, 30300
Soroka Medical Center
Beersheba, Southern District, 8410101
Hillel Yaffe Medical Center
Hadera, Northern District, 3810101
Rambam Health Care Campus
Haifa, Northern District, 3109601
Bnai Zion Medical Center
Haifa, Ḥeifā, 3339419
Linn Medical Center
Haifa, Ḥeifā, 3515209
Edith Wolfson Medical Center
Holon, Central District, 5810001
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
Hadassah Mount Scopus Medical Centre
Jerusalem, Jerusalem, 9124001
Clalit Health Services Diabetes and Endocrinology Clinic Jerusalem
Jerusalem, Jerusalem, 93106
Meir Medical Center
Kfar Saba, Central District, 4428164
Galilee Medical Center
Nahariya, Northern District, 2210001
Holy Family Hospital
Nazareth, Northern District, 16100
Rabin Medical Center - Hasharon Campus
Petah Tikva, Central District, 49202
Rabin Medical Center
Petah Tikva, Central District
Sheba Medical Center
Ramat Gan, Central District, 5262100
Kaplan Medical Center
Rehovot, Central District, 7610001
ZIV Medical Center
Safed, Northern District, 1311001
Clalit Health Services - Sakhnin Community Clinic
Sakhnin, Northern District, 3081000
Sourasky Medical Center
Tel Aviv, Tell Abīb, 6423906
Russia23 sites
Arkhangelsk Regional Clinical Hospital
Arkhangelsk, Arkhangelskaya oblast, 163045
First City Clinical Hospital E.E. Volosevich
Arkhangelsk, Arkhangelskaya oblast, 163045
National Medical Research Center for therapy and preventive medicine
Moscow, Moscow, 101990
Endocrinology Research Center of Rosmedtechnologies
Moscow, Moscow, 117036
Pirogov Russian National Research Medical University
Moscow, Moscow, 117997
First Moscow State Medical University I.M. Sechenov
Moscow, Moscow, 119991
Russian Cardiology Research and Production Complex
Moscow, Moscow, 121552
Moscow City Clinical Hospital Number 52
Moscow, Moscow, 123182
M. F. Vladimirskiy Moscow Regional Research Clinical Institute
Moscow, Moscow, 129110
Moscow City Clinical Hospital Number 52
Moscow, Moscow
Novosibirsk State Medical University
Novosibirsk, Novosibirsk Oblast, 630087
Rostov State Medical University
Rostov-on-Don, Rostov Oblast, 344022
Ryazan Regional Clinical Cardiological Dispensary
Ryazan, Ryazan Oblast, 390026
City Mariinskaya Hospital
Saint Petersburg, Leningradskaya Oblast', 191104
S.M. Kirov Military Medical Academy
Saint Petersburg, Sankt-Peterburg, 194044
Saint-Petersburg City Hospital of Saint Elizabeth
Saint Petersburg, Sankt-Peterburg, 195257
Astarta Clinic
Saint Petersburg, Sankt-Peterburg, 199226
Regional Clinical Hospital of the Saratov Region
Saratov, Saratov Oblast, 410053
Advisory Diagnostic Centre
Syktyvkar, Komi, 167000
Tomsk Regional Clinical Hospital
Tomsk, Tomsk Oblast, 634063
Siberian State Medical University
Tomsk, Tomsk Oblast
Research & Practice
Yaroslavl, Yaroslavl Oblast, 150003
Yaroslavl State Med Acad Clinical Hospital
Yaroslavl, Yaroslavl Oblast, 150010
Ukraine21 sites
Regional Communal Non-commercial enterprise "Chernivtsi regional clinical hospital"
Chernivtsi, Chernivetska Oblast, 58000
Dnipropetrovsk City Clinical Hospital No. 9
Dnipro, Dnipropetrovsk Oblast, 49023
Ukrainian State Research Institute Of Medical And Social Problems Of Disability
Dnipro, Dnipropetrovsk Oblast, 49027
City Clinical Hospital No. 2
Kharkiv, Kharkiv Oblast, 61037
L.T. Mala National Institute of Therapy of NAMS of Ukraine
Kharkiv, Kharkiv Oblast, 61039
Municipal Non-Profit Enterprise "City clinical hospital №8" of Kharkiv city council
Kharkiv, Kharkiv Oblast, 61176
Institute of Endocrinology and Metabolism named after Komissarenko
Kiev, Kyiv Oblast, 04114
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
Kiev, Kyiv Oblast, 4050
Institute of Endocrinology and Metabolism named after Komissarenko
Kiev, Kyiv Oblast, 4114
ARTEM
Kiev, Kyivska Oblast, 04050
Medbud Clinic
Kyiv, Kyivska Oblast, 3037
Medical Center Ok!Clinic+
Kyiv, 02091
Branch "Center of Endocrinological Health" of "Lviv Regional Clinical Diagnostic Center"
Lviv, Lviv Oblast, 79000
Lviv City Clinical Hospital #4
Lviv, Lviv Oblast, 79011
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
Odesa, Odesa Oblast, 65025
Municipal non-profit enterprise "Consultative-diagnostic center №20" of Odesa city council
Odesa, Odesa Oblast, 65114
Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
Poltava, Poltava Oblast, 36011
Municipal enterprise "1st City clinical hospital of Poltava City Council", Poltava State Medical University
Poltava, Poltava Oblast, 36038
Municipal Non-Profit Enterprise Of Sumy Regional Council ''Sumy Regional Clinical Hospital''
Sumy, Sumska Oblast, 40031
Vinnytsia Regional Clinical Endocrinology Dispensary
Vinnytsia, Vinnytsia Oblast, 21010
Municipal non-profit enterprise "City Hospital #7" of Zaporizhzhia City Council
Zaporizhzhya, Zaporizhzhia Oblast, 69118
Australia20 sites
Nightingale Research
Adelaide, South Australia, 5000
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Box Hill Hospital
Box Hill, Victoria, 3128
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Core Research Group
Brisbane, Queensland, 4064
Mater Misericordiae Limited
Brisbane, Queensland, 4101
Victorian Heart Hospital
Clayton, Victoria, 3168
School of Medicine, Fremantle Hospital
Fremantle, Western Australia, 6160
Barwon Health
Geelong, Victoria, 3220
Austin Health - Repatriation Hospital
Heidelberg West, Victoria, 3084
Advara HeartCare Joondalup
Joondalup, Western Australia, 6027
Launceston General Hospital
Launceston, Tasmania, 7250
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, 2291
GenesisCare - Murdoch - Murdoch Drive
Murdoch, Western Australia, 6150
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046
Nepean Hospital
Penrith, New South Wales, 2747
Gold Coast University Hospital
Southport, Queensland, 4215
University of Sydney - Charles Perkins Centre
Sydney, New South Wales, 2006
The Townsville Hospital
Townsville, Queensland, 4814
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, 2500
Italy20 sites
A.O.U.C. Policlinico di Bari
Bari, Apulia, 70124
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, 24127
IRCCS - AOU di Bologna
Bologna, 40138
Azienda Ospedaliera Garibaldi
Catania, 95124
Azienda Ospedaliera Mater Domini
Catanzaro, 88100
Ospedale Maggiore Pronto Soccorso
Chieri, Torino, 10023
Università degli Studi Gabriele D' Annunzio
Chieti, 66100
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Centro Cardiologico Monzino
Milan, 20138
Universita degli Studi della Campania Luigi Vanvitelli
Naples, Campania, 80138
Ospedale san Giovanni di Dio-Diabetologia
Olbia, Sardinia, 7026
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90129
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Fondazione Salvatore Maugeri Clinica del lavoro
Pavia, 27100
Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, 56124
Fondazione Policlinico Tor Vergata
Rome, Lazio, 133
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 168
Ospedale San Giovanni Calibita Fatebenefratelli
Rome, Lazio, 186
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Veneto, 37126
Romania20 sites
Private Practice - Dr. Diana Barbonta
Alba Iulia, Alba, 510134
CMI Dr.Pletea Noemi SRL
Bacau, 600154
SC Minimed SRL
Bacau, 600238
CMI DNBM Dr. Pop Lavinia
Baia Mare, Maramureş, 430222
C.M.D.T.A. Neomed
Brasov, Brașov County, 500283
Nicodiab
Bucharest, Bucharest, 10507
Geea Medical Easy Diet
Bucharest, Bucharest, 10627
Centrul Medical NutriLife
Bucharest, Bucharest, 13764
The National Institute of Diabetes, Nutrition and Metabolic Diseases "Prof. Dr. N. Paulescu"
Bucharest, Bucharest, 20475
Top Diabet SRL
Craiova, Dolj, 200678
Diamed Obesity
Galați, 800291
Olimpia Med
Iași, 400002
Centrul Medical Consultmed
Iași, 700514
Gama Diamed
Mangalia, Constanța County, 905500
Diabdana
Oradea, Bihor County, 410147
Centrul Medical Grandmed
Oradea, Bihor County, 410159
Diabmed Dr. Popescu Alexandrina
Ploieşti, Prahova, 100163
Dianutrilife Medica
Ploieşti, Prahova, 100561
SC Dentosim Queen SRL - Centrul Medical Diamed
Târgu Mureş, Mureș County, 540098
Centru Medical Dr. Negrisanu
Timișoara, Timiș County, 300456
Spain20 sites
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Comunidad de, 28805
Centro Periférico de Especialidades Bola Azul
Almería, Almería, 4009
Hospital Universitario de La Ribera
Alzira, València, 46600
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, A Coruña [La Coruña], 15405
Hospital Unviersitario Virgen Nieves
Granada, 18012
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
Hospital Universitario Central de Asturias
Oviedo, Asturias, Principado de, 33011
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Virgen del Camino
Sanlúcar de Barrameda, Cádiz, 11540
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [La Coruña], 15706
Hospital Quiron Infanta Luisa
Seville, Andalusia, 41010
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital General Universitario de Valencia
Valencia, Valenciana, Comunitat, 46014
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, 47003
Hospital Virgen de las Montañas
Villamartín, Cádiz, 11650
Poland19 sites
Legeartis - Poradnie Specjalistyczne
Bialystok, Podlaskie Voivodeship, 15-404
Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Osrodek Diabetologiczny Popula Spolka Cywilna
Bialystok, Podlaskie Voivodeship, 15445
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546
NZOZ Salvia CM
Katowice, Silesian Voivodeship, 40-772
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódź Voivodeship, 90338
CenterMed Lublin NZOZ
Lublin, Lublin Voivodeship, 20-044
Gabinety TERPA
Lublin, Lublin Voivodeship, 20-333
NZOZ Medica
Lublin, Lublin Voivodeship, 20-538
OMEDICA Medical Center
Poznan, Greater Poland Voivodeship, 60-111
Gaja Poradnie Lekarskie Maciej Wiza
Poznan, Greater Poland Voivodeship, 61-251
Private Practice - Dr. Ewa Krzyzagorska
Poznan, Greater Poland Voivodeship, 61-655
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Ruda Śląska, Silesian Voivodeship, 41-709
Private Practice - Dr. Robert Witek
Tarnów, Lesser Poland Voivodeship, 33-100
Centrum Medyczne AMED
Warsaw, Masovian Voivodeship, 00-215
Instytut Diabetologii
Warsaw, Masovian Voivodeship, 02-117
ETG NETWORK Sp. z o.o.
Warsaw, Masovian Voivodeship, 02-677
NZOZ Regionalna Poradnia Diabetologiczna
Wroclaw, Lower Silesian Voivodeship, 50-127
Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej
Wroclaw, Lower Silesian Voivodeship, 50-403
Turkey (Türkiye)19 sites
Akdeniz Universitesi Hastanesi
Antalya, 7070
Adnan Menderes University Medical Faculty
Aydin, 9100
Dokuz Eylül Üniversitesi
Balçova, İzmir, 35340
Ege Universitesi Hastanesi
Bornova, İzmir, 35100
Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre
Denizli
Atatürk Üniversitesi
Erzurum, 25070
Eskisehir Osmangazi University
Eskişehir, Eskişehir, 26040
Gaziantep Üniversitesi Gaziantep Onkoloji Hastanesi
Gaziantep, 27000
Koç Üniversitesi Hastanesi
Istanbul, 34010
Dr. Sadi Konuk Egitim ve Arastirma Hastanesi
Istanbul, 34147
Acibadem Universitesi Atakent Hastanesi
Istanbul, 34303
Göztepe Eitim Ve Aratrma Hastanesi
Istanbul, 34722
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34752
Erciyes University Medical Faculty
Kayseri, 38030
Kocaeli Üniversitesi
Kocaeli, 41380
İnönü Üniversitesi Turgut Özal Tıp Merkezi
Malatya, 44280
Dicle Üniversitesi
Sur, Diyarbakır, 21200
Mersin University Medical Faculty
Yenişehir, Mersin, 33110
Baskent University Dr. Turgut Noyan Research and Training Center
Yüreğir, Adana, 01250
Netherlands18 sites
Jeroen Bosch ziekenhuis
's-Hertogenbosch, North Brabant, 5223 GZ
EB Utrecht
Almere Stad, Flevoland, 1311RL
Ziekenhuis Amstelland
Amstelveen, North Holland, 1186 AM
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, 1081 HV
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, 1105 AZ
Ziekenhuis Rijnstate
Arnhem, Gelderland, 6815 AD
Reinier de Graaf Ziekenhuis, locatie Delft
Delft, South Holland, 2625 AD
Het Van Weel-Bethesda Ziekenhuis - Ziekenhuis Dirksland
Dirksland, South Holland, 3247 BW
Slingeland Ziekenhuis
Doetinchem, Gelderland, 7009 BL
Ziekenhuis Gelderse Vallei
Ede, Gelderland, 6716 RP
Spaarne Gasthuis, Haarlem Zuid
Haarlem, North Holland, 2035 RC
Saxenburgh Medisch Centrum
Hardenberg, Overijssel, 7772 SE
Ziekenhuis Bethesda
Hoogeveen, Drenthe, 7909 AA
Radboudumc
Nijmegen, Gelderland, 6525 GA
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ
Franciscus Gasthuis & Vlietland, Locatie Gasthuis
Rotterdam, South Holland, 3045 PM
Diakonessenhuis, locatie Utrecht
Utrecht, 3582 KE
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Hungary17 sites
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém megye, 8230
Szent Margit Rendelőintézet Nonprofit Kft
Budapest, 1032
ClinDiab Kft.
Budapest, 1089
Szent János Kórház
Budapest, 1125
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1134
Strazsahegy Medicina Bt.
Budapest, H1171
Debreceni Egyetem Kenézy Gyula Egyetemi Kórház
Debrecen, Hajdú-Bihar, 4031
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Markhot Ferenc Oktatókórház
Eger, Heves County, 3300
Pharma 4 Trial
Gyöngyös, Heves County, 3200
Studium Egeszseghaz Kft
Kalocsa, Bács-Kiskun county, 6300
Selye János Kórház
Komárom, Komárom-Esztergom, 2900
Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, 8800
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, 6725
Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, Fejér, 8000
CLINFAN Szolgáltató Kft
Szekszárd, Tolna County, 7100
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, Zala County, 8900
Brazil15 sites
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, 13060-080
Loema Instituto de Pesquisa Clinica
Campinas, São Paulo, 13092-133
Quanta Diagnóstico e Terapia
Curitiba, Paraná, 80045170
Private Practice - Dr.Miguel N. Hissa
Fortaleza, Ceará, 60430-350
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, 17201130
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 22241-180
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, 12243-280
Instituto de Pesquisa Clinica
São Paulo, São Paulo, 01223-001
CPCLIN
São Paulo, São Paulo, 01228-200
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Hospital das Clinicas FMUSP
São Paulo, 04266-010
Hospital das Clinicas FMUSP
São Paulo, 05403-000
CEDOES
Vitória, Espírito Santo, 29055450
Belgium14 sites
AZORG Campus Aalst-Moorselbaan
Aalst, Oost-Vlaanderen, 9300
Imelda General Hospital
Bonheiden, Antwerpen, 2820
Algemeen Ziekenhuis klina
Brasschaat, Antwerpen, 2930
AZ Sint-Jan Brugge-Oostende AV
Bruges, West-Vlaanderen, 8000
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-Capitale, Région de, 1070
UZ Brussel
Brussels, Bruxelles-Capitale, Région de, 1090
Antwerp University Hospital
Edegem, Antwerpen, 2650
AZ Groeninge Campus Kennedylaan
Kortrijk, West-Vlaanderen, 8500
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
ZAS Jan Palfijn
Merksem, Flanders, 2170
Az Damiaan vzw
Ostend, West-Vlaanderen, 8400
AZ Delta vzw
Roeselare, West-Vlaanderen, 8800
AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, B-9100
India14 sites
Gujarat Endocrin Pvt Ltd
Ahmedabad, Gujarat, 380052
Marengo CIMS Hospital
Ahmedabad, Gujarat, 380060
Bangalore Diabetes Centre
Bangalore, Karnataka, 560043
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086
Care Hospitals Hyderabad- Banjara Hills
Hyderabad, Telangana, 500034
CARE CHL-Hospitals
Indore, Madhya Pradesh, 452008
Apollo Multispeciality Hospitals limited
Kolkata, West Bengal, 700054
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, Maharashtra, 400008
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
Mumbai, Maharashtra, 400012
Kingsway Hospitals (Best Multispeciality Hospital in Nagpur)
Nagpur, Maharashtra, 440001
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, National Capital Territory of Delhi, 110002
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Batra Hospital and Medical Research Centre
New Delhi, National Capital Territory of Delhi, 110062
United Kingdom12 sites
Aberdeen Royal Infirmary
Aberdeen, Aberdeen City, AB25 2ZN
Southmead Hospital
Bristol, Bristol, City of, BS10 5NB
Ninewells Hospital and Medical School
Dundee, Angus, DD1 9SY
Staploe Medical Centre
Ely, Cambridgeshire, CB7 5JD
Glasgow Royal Infirmary
Glasgow, Glasgow City, G4 0SF
Hull Royal Infirmary
Hull, Kingston Upon Hull, HU3 2JZ
Ipswich Hospital
Ipswich, Suffolk, IP4 5PD
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW
University Hospital Aintree
Liverpool, L9 7AL
Knowle House Surgery
Plymouth, Devon, PL5 3JB
Morriston Hospital
Swansea, Swansea [Abertawe Gb-ata], SA6 6SG
The Royal Cornwall Hospital
Truro, England, TR1 3LJ
France11 sites
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, Île-de-France Region, 91106
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
Dijon, Côte-d'Or, 21000
Hôtel-Dieu du Creusot - site Harfleur
Le Creusot, Bourgogne-Franche-Comté, 71200
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
Paris, 75010
Hôpital Bichat - Claude-Bernard
Paris, 75018
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, 75014
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-Atlantique, 44800
CHU Rangueil
Toulouse, Haute-Garonne, 31059
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Lorraine, 54511
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, Auvergne-Rhône-Alpes, 69200
Czechia10 sites
Diacentrum Brandys n.L. s.r.o.
Brandýs nad Labem, Praha-východ, 25001
MUDr. Alena Vachova
České Budějovice, South Bohemian Region, 37011
MUDr. Tomas Edelsberger
Krnov, Moravian-Silesian Region, 79401
Interni a diabetologicka ordinace, s.r.o.
Náchod, Náchod, 547 01
Diabet2 s.r.o., diabetologicka a interni ambulance
Prague, Praha 1, 11000
ResTrial s.r.o.
Prague, Praha 8, 18100
Vseobecna fakultni nemocnice v Praze
Prague, 12808
MUDr. Michala Pelikanova s.r.o.
Prague, 140 00
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, 14900
MUDr. Barbora Diepoltova
Praha 9 - Klanovice, Praha 9, 190 14
Greece10 sites
Athens Euroclinic
Athens, Attikí (Region), 115 21
General Hospital of Athens "G. Gennimatas"
Athens, Attikí, 11527
Attikon General University Hospital
Chaïdári, Attikí, 12462
University General Hospital of Larissa
Larissa, Thessalía, 41110
Iatriko Paleou Falirou Medical Center
Palaió Fáliro, Attikí (Region), 17562
Thermi Clinic
Thermi, Thessaloniki, Thessaloníki, 570 01
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, 54642
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 546 36
Euromedica General Clinic of Thessaloniki
Thessaloniki, Thessaloníki, 546 45
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 564 03
South Korea10 sites
Keimyung University Dongsan Hospital
Daegu, Taegu-Kwangyǒkshi, 42601
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 2841
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 3080
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 3722
Kyung Hee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [Seoul], 5278
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 5505
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 6591
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 7441
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, 44033
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Kang-won-do, 26426
Japan9 sites
The Institute of Medical Science, Asahi Life Foundation
Chuo-ku, Tokyo, 103-0002
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
Jinnouchi Hospital
Kumamoto, 862-0976
Medical Corporation Sato Medical clinic
Ootaku, Tokyo, 143-0015
AMC Nishiumeda Clinic
Osaka, 530-0001
Sakurabashi Watanabe Advanced Healthcare Hospital
Osaka, 530-0005
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1045
Uji-Tokushukai Medical Center
Uji, Kyoto, 611-0041
Slovakia9 sites
Diacrin s.r.o.
Bratislava, Bratislava Region, 831 01
IN-DIA
Lučenec, Banská Bystrica Region, 984 01
Sin Azucar
Malacky, Bratislava Region, 901 01
Funkystuff
Nové Zámky, Nitra Region, 940 01
Diabetol
Prešov, Presov, 080 01
DIA-MED CENTRUM s.r.o.
Púchov, Trenčín Region, 020 01
DIAB sro
Rožňava, Košice Region, 048 01
MED-DIA s.r.o
Sabinov, Presov, 8301
Diabetes Centrum
Trenčín, Trenčín Region, 911 01
Taiwan9 sites
Changhua Christian Hospital
Changhua County, Changhua, 50006
Mackay Memorial Hospital-Hsinchu
Hsinchu, Hsinchu, 300
Hualien Tzu Chi Medical Center
Hualien City, Hualien, 970
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Taichung Veterans General Hospital
Taichung, 407
Chi Mei Medical Center
Tainan, Tainan, 71004
National Cheng-Kung Uni. Hosp.
Tainan, 704
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Austria6 sites
Medizinische Universität Graz
Graz, Styria, 8036
Uniklinikum Salzburg
Salzburg, 5020
Klinik Landstraße
Vienna, 1030
Zentrum für klinische Studien Dr Hanusch Gmbh
Vienna, 1060
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
Klinik Hietzing
Vienna, 1130
Sweden6 sites
ProbarE
Lund, Skåne Län [se-12], 222 22
Sahlgrenska Universitetssjukhuset Mölndal
Mölndal, Västra Götalands Län [se-14], 431 80
Universitetssjukhuset Örebro
Örebro, Örebro Län [se-18], 701 85
Östersunds Sjukhus
Östersund, Jämtlands Län [se-23], 831 31
Dalecarlia Clinical Research Center
Rättvik, Dalarnas Län [se-20], 795 30
Citydiabetes
Stockholm, Stockholms Län [se-01], 112 21
Puerto Rico5 sites
Advanced Clinical Research, LLC
Bayamón, 00959
Manati Center for Clinical Research
Manati, 00674
Research and Cardiovascular Corp.
Ponce, 00717
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917
San Juan City Hospital
San Juan, 00935
About this study
Official title: The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Tirzepatide, Dulaglutide
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hypoglycemic Agents, Physiological Effects of Drugs, Tirzepatide, Incretins, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
DulaglutideDrug
Also called LY2189265
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide - Maximum Tolerated Dose (MTD) | Experimental | Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered as subcutaneous (SC) injection once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW) for up to 5 years. Receives: Drug: Tirzepatide |
| 1.5 mg Dulaglutide | Experimental | Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years. Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke]
Number of participants with first occurrence of Clinical Endpoint Committee (CEC), a composite endpoint i.e., from time of randomization to first occurrence of cardiovascular (CV) death, myocardial infarction and stroke combined data was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Secondary outcomes (13)
Number of Participants From Randomization to Time to Occurrence of All-Cause Death
The number of participants from randomization to time to occurrence of Clinical Endpoint Committee (CEC) confirmed all-cause death was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of all-cause death during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time of Occurrence of CV Death
Number of participants from time of randomization to time to occurrence of CEC confirmed CV death was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of CV death during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of Myocardial Infarction (MI)
The number of participants from randomization to first occurrence of CEC confirmed MI was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of nonfatal MI during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Number of Participants From Randomization toTime to First Occurrence of Stroke
The number of participants from randomization to first occurrence of CEC confirmed stroke was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of nonfatal stroke during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of the Expanded Composite of CV Death, MI, Stroke or Coronary Revascularization (MACE-4)
The number of participants from randomization to first occurrence of MACE-4 was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of CV Deaths or Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits
The number of participants from randomization to first occurrence of Clinical Endpoint Committee (CEC) confirmed heart failure requiring hospitalisation or urgent heart failure was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of Revascularization
The number of participants from randomization to first occurrence of coronary revascularization was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of revascularization during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of New or Worsening Nephropathy
New or worsening nephropathy (Composite Endpoint 1) was defined as the first occurrence of any of the following events:
persistent macroalbuminuria (urine albumin-to-creatinine ratio >300 mg/g), persistent doubling of serum creatinine with eGFR <45 mL/min/1.73 m², onset of end-stage renal disease (including initiation of chronic dialysis or kidney transplantation), or death due to renal disease.
Time to event was defined as the number of days from the date of randomization to the first occurrence any of these events. during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
Measured: From randomization (week 0) up to week 259
Change From Baseline to 36 Months in Estimated Glomerular Filtration Rate (eGFR) in Patients With High or Very-high Risk Chronic Kidney Disease (CKD)
Change from baseline in eGFR calculated as difference between value at 36 months and baseline value. Participants included in this analysis were classified as having high or very high risk of chronic kidney disease at baseline based on their kidney function (eGFR) and urine albumin-to-creatinine ratio (UACR). High risk included participants with eGFR 45 to less than 60 milliliters/minutes/1.73 square metres (mL/min/1.73 m²) and UACR greater than 30 mg/g, or eGFR 60 mL/min/1.73 m² or higher with UACR greater than 300 mg/g. Very high risk included participants with eGFR less than 45 mL/min/1.73 m² or severely increased UACR (greater than 300 mg/g). These criteria are associated with an increased risk of worsening kidney function. Least squares (LS) mean was calculated using analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline sodium-glucose cotransporter-2 (SGLT-2) Use Flag.
Measured: Baseline, 36 Months
Change From Baseline to 36 Months in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Change in HbA1c from baseline up to 36 months during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
LS mean was calculated using ANCOVA model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares).
Measured: Baseline, 36 Months
Percent Change From Baseline to 36 Months in Body Weight
LS mean was calculated using ANCOVA model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares)
Measured: Baseline, 36 Months
Percent Change From Baseline to 36 Months in Urinary Albumin to Creatinine Ratio (UACR)
Urine samples were collected for the analysis of UACR. UACR (gram per kilograms [g/kg]) was calculated as urine albumin (gram per liter [g/L])/urine creatinine (kg/L). Percent change from baseline at 36 months was calculated as: [(UACR at 36 months - baseline UACR) / baseline UACR] × 100.
LS mean was calculated using ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares).
Measured: Baseline, 36 Months
Percent Change From Baseline to 24 Months in Blood Lipids (Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), and Triglycerides (TG))
Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, LDL-C, HDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment.
LS mean was calculated using ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment + Analysis Country + Baseline SGLT-2i Use Flag.
Measured: Baseline, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start29 May 2020
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13,299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255433
- Sponsor's protocol ID
- 17073
- Other IDs
- I8F-MC-GPGN, 2019-002735-28, 2023-507846-96-00, 2023, 2019
- Acronym
- SURPASS-CVOT
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2020
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Nissen SE, Wolski K, D'Alessio D, Weerakkody G, Kiljanski J, Wiese RJ, Pavo I, Cariou B, Nicholls SJ. Cardiorenal Outcomes With Tirzepatide Compared With Dulaglutide in Patients With Diabetes and Cardiovascular Disease: A Post Hoc Analysis of the SURPASS-CVOT Randomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):544-552. doi: 10.1001/jamacardio.2026.0767.
PubMed 41903177Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE, Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D; SURPASS-CVOT Investigators. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. N Engl J Med. 2025 Dec 18;393(24):2409-2420. doi: 10.1056/NEJMoa2505928.
PubMed 41406444Khawaji A, A Jaly A, A Bakri H, Ravi R, Hattan A, Khawaji A, Najmi W. Weight Loss Efficacy of Tirzepatide Compared to Placebo or GLP-1 Receptor Agonists in Adults With Obesity or Overweight: A Meta-Analysis of Randomized Controlled Trials With >/= 20 Weeks Treatment Duration. J Obes. 2025 Jul 24;2025:3442754. doi: 10.1155/jobe/3442754. eCollection 2025.
PubMed 40746703Kaneko S. Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes. touchREV Endocrinol. 2022 Jun;18(1):10-19. doi: 10.17925/EE.2022.18.1.10. Epub 2022 Jun 16.
PubMed 35949358
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)
- ClinicalTrials.gov ID
- NCT04255433
- Acronym / sponsor ID
- SURPASS-CVOT / 17073
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hypoglycemic Agents, Physiological Effects of Drugs, Tirzepatide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,299 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide - Maximum Tolerated Dose (MTD) | Experimental | Drug: TirzepatideParticipants received a starting dose of 2.5 milligrams (mg) tirzepatide administered as subcutaneous (SC) injection once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW) for up to 5 years. |
| 1.5 mg Dulaglutide | Experimental | Drug: DulaglutideParticipants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Men or women at least 40 years old with a diagnosis of type 2 diabetes
- Established cardiovascular disease, including at least 1 of the following:
- HbA1c ≥7% (≥53 mmol/mol) and ≤10.5% (≤91.3 mmol/mol) based on central laboratory assessment at screening
- Body mass index (BMI) ≥25 kg/m2
- At the time of signing the informed consent: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
Key exclusion criteria (28 listed)
- Have type 1 diabetes mellitus
- Have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the physician
- Have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to screening
- Are currently planning treatment for diabetic retinopathy and/or macular edema.
- Have been hospitalized for congestive heart failure (CHF) within 2 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Tirzepatide - Maximum Tolerated Dose (MTD) |
| DulaglutideAlso: LY2189265Administered SC | Drug | 1.5 mg Dulaglutide |
Primary outcome
Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke]
Time frame: From randomization (week 0) up to week 259
Number of participants with first occurrence of Clinical Endpoint Committee (CEC), a composite endpoint i.e., from time of randomization to first occurrence of cardiovascular (CV) death, myocardial infarction and stroke combined data was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.
13 secondary outcomes
Number of Participants From Randomization to Time to Occurrence of All-Cause Death
Time frame: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time of Occurrence of CV Death
Time frame: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of Myocardial Infarction (MI)
Time frame: From randomization (week 0) up to week 259
Number of Participants From Randomization toTime to First Occurrence of Stroke
Time frame: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of the Expanded Composite of CV Death, MI, Stroke or Coronary Revascularization (MACE-4)
Time frame: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of CV Deaths or Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits
Time frame: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of Revascularization
Time frame: From randomization (week 0) up to week 259
Number of Participants From Randomization to Time to First Occurrence of New or Worsening Nephropathy
Time frame: From randomization (week 0) up to week 259
Change From Baseline to 36 Months in Estimated Glomerular Filtration Rate (eGFR) in Patients With High or Very-high Risk Chronic Kidney Disease (CKD)
Time frame: Baseline, 36 Months
Change From Baseline to 36 Months in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 36 Months
Percent Change From Baseline to 36 Months in Body Weight
Time frame: Baseline, 36 Months
Percent Change From Baseline to 36 Months in Urinary Albumin to Creatinine Ratio (UACR)
Time frame: Baseline, 36 Months
Percent Change From Baseline to 24 Months in Blood Lipids (Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), and Triglycerides (TG))
Time frame: Baseline, 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41903177Nissen SE, Wolski K, D'Alessio D, Weerakkody G, Kiljanski J, Wiese RJ, Pavo I, Cariou B, Nicholls SJ. Cardiorenal Outcomes With Tirzepatide Compared With Dulaglutide in Patients With Diabetes and Cardiovascular Disease: A Post Hoc Analysis of the SURPASS-CVOT Randomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):544-552. doi: 10.1001/jamacardio.2026.0767.
- Derived from this study: PubMed 41406444Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE, Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D; SURPASS-CVOT Investigators. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. N Engl J Med. 2025 Dec 18;393(24):2409-2420. doi: 10.1056/NEJMoa2505928.
- Derived from this study: PubMed 40746703Khawaji A, A Jaly A, A Bakri H, Ravi R, Hattan A, Khawaji A, Najmi W. Weight Loss Efficacy of Tirzepatide Compared to Placebo or GLP-1 Receptor Agonists in Adults With Obesity or Overweight: A Meta-Analysis of Randomized Controlled Trials With >/= 20 Weeks Treatment Duration. J Obes. 2025 Jul 24;2025:3442754. doi: 10.1155/jobe/3442754. eCollection 2025.
- Derived from this study: PubMed 35949358Kaneko S. Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes. touchREV Endocrinol. 2022 Jun;18(1):10-19. doi: 10.17925/EE.2022.18.1.10. Epub 2022 Jun 16.
- A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
635 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide and Dulaglutide in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 635 sites in 31 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 34 inclusion and 28 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 635 sites in United States, Germany, Argentina, Canada, Mexico and 26 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. 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 Jul 2026). 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?
Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke] (time frame: From randomization (week 0) up to week 259). 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 NCT04255433, which also lists 4 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 Jul 2026.