Diabetes Mellitus, Type 2Phase 3SOULNCT03914326
A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes
A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 492 sites in 34 countries.
Trial summary
The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,651 participants
- Where
- 492 sitesin 34 countries
- Study dates
- 17 Jun 2019to 23 Aug 2024
- Phase
- Phase 3
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age equal to or above 50 years at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus
- HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement)
- At least one of the below conditions (a-d):
- Coronary heart disease defined as at least one of the following: i. Prior myocardial infarction ii. Prior coronary revascularisation procedure iii. 50% or above stenosis in coronary artery documented by cardiac catheterisation, computerized tomography coronary angiography iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke ii. Prior carotid artery revascularisation procedure iii.50% or above stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest ii. Intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularization procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) d) Chronic kidney disease defined as: i. eGFR below 60 mL/min/1.73 m^2 (based on medical records using latest available and no more than 6 months old assessment)
Who cannot join
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Heart failure presently classified as being in New York Heart Association Class IV
- Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening
Trial locations and contacts
492 sites in 34 countries.
492 sites in 34 countries
United States91 sites
AMC Community Endocrinology
Albany, New York, 12203
Ellipsis Group
Alpharetta, Georgia, 30022
Arlington Family Res. Ctr Inc
Arlington, Texas, 76012-4637
Mountain Diabetes & Endocrine Center
Asheville, North Carolina, 28803
Rocky Mount Reg VA Med-DN
Aurora, Colorado, 80045
Central Texas Clinical Research
Austin, Texas, 78705
Texas Diabetes & Endocrinology, P.A._Austin
Austin, Texas, 78731
Texas Diabetes & Endocrinology
Austin, Texas, 78749
Heritage Valley Medical Group Inc
Beaver, Pennsylvania, 15009
East Coast Medical Associates, Inc.
Boca Raton, Florida, 33433
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620
Kernodle Clin Dpt-Pvt Diagnost
Burlington, North Carolina, 27215
University of North Carolina
Chapel Hill, North Carolina, 27514
Michael L Reeves, MD
Chattanooga, Tennessee, 37404
Univ Diab & Endo Consultants
Chattanooga, Tennessee, 37411
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302
Creekside Endocrine Associates, PC
Denver, Colorado, 80246
Lillestol Research LLC
Fargo, North Dakota, 58104
Diabetes and Thyroid Ctr of FW
Fort Worth, Texas, 76132
American Health Network of IN LLC_Franklin
Franklin, Indiana, 46131
B&K Medical Research Center
Fresno, California, 93721-1443
University of Vermont Medical Center
Fullerton, California, 92835
New West Physicians,Inc.
Golden, Colorado, 80401
American Health Network of Indiana, LLC_Greenfield
Greenfield, Indiana, 46140
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
Physicians East Endocrinology
Greenville, North Carolina, 27834
Clinical Invest Special_Gurnee
Gurnee, Illinois, 60031
East West Med Res Inst
Honolulu, Hawaii, 96814
PrimeCare Medical Group
Houston, Texas, 77024
Synergy Groups Medical
Houston, Texas, 77061
Rocky Mountain Diab&Osteo Ctr
Idaho Falls, Idaho, 83404-7596
Clinical Investigation Spec. Kenosha
Kenosha, Wisconsin, 60031
Holston Medical Group
Kingsport, Tennessee, 37660
Scripps Whittier Diabetes Inst
La Jolla, California, 92037
Diabetes & Endocrine Associates
La Mesa, California, 91942
First Valley Medical Group
Lancaster, California, 93534
Palm Research Center Inc-Vegas
Las Vegas, Nevada, 89128
Physicians Research Assoc. LLC
Lawrenceville, Georgia, 30046
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03766
The Research Group of Lexington LLC
Lexington, Kentucky, 40503
Medical Investigations, Inc.
Little Rock, Arkansas, 72211
DCOL Ctr for Clin Res
Longview, Texas, 75605
Pacific Clinical Studies
Los Alamitos, California, 90720
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
L-MARC Research Center
Louisville, Kentucky, 40213
Awasty Research Network,LLC
Marion, Ohio, 43302
Advanced Med Res Maumee
Maumee, Ohio, 43537
Primary Care Research South, Inc
McMurray, Pennsylvania, 15317
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, 44060
Franciscan Health Michigan City
Michigan City, Indiana, 46360
Midland Clinical Research Center
Midland, Texas, 79707
Facey Medical Foundation
Mission Hills, California, 91345
Monterey Endocrine & Diabetes Institute, Inc
Monterey, California, 93940
Chambliss Clinical Trials, LLC
Montgomery, Alabama, 36106
American Health Network of IN LLC
Muncie, Indiana, 47304
The Diabetes Center, LLC
Murrells Inlet, South Carolina, 29576
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03060
InvestiClin Research
Nashville, Tennessee, 37203
MidState Endocrine Associates
Nashville, Tennessee, 37203
Vanderbilt Diab Obes Clin Tri
Nashville, Tennessee, 37212
Eastern Nephr Assoc, PLLC
New Bern, North Carolina, 28562
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Suncoast Clin Res Port Richey
New Port Richey, Florida, 34652
Lynn Institute of Norman
Norman, Oklahoma, 73072
Methodist Phys. Clinic
Omaha, Nebraska, 68114
Univ of Nebraska Medical CTR
Omaha, Nebraska, 68198-3020
AdventHealth Diab Inst
Orlando, Florida, 32804
Desert Oasis Hlthcr Med Group
Palm Springs, California, 92262
Aria Endocrine Metabolic Assoc
Philadelphia, Pennsylvania, 19114
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, 15243
Dominion Medical Associates
Richmond, Virginia, 23219
Endo Res Solutions Inc
Roswell, Georgia, 30076
Texas Diabetes & Endocrinology, P.A._Austin
Round Rock, Texas, 78681
San Diego Family Care
San Diego, California, 92111
Unity Health-Searcy Medical Center
Searcy, Arkansas, 72143
Ileana J Tandron APMC
Slidell, Louisiana, 70461-4231
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Simcare Medical Research, LLC
Sugar Land, Texas, 77478
Lundquist Inst-Biomed Innovtn
Torrance, California, 90502
Trinity Clinical Research LLC
Tullahoma, Tennessee, 37388
Twinsburg Family Health Center
Twinsburg, Ohio, 44087
Coastal Metabolic Research Center
Ventura, California, 93003
Hillcrest Family Health Center
Waco, Texas, 76708
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266
Southgate Medical Group, LLP
West Seneca, New York, 14224
Great Lakes Medical Research
Westfield, New York, 14787
Whiteville Medical Associates
Whiteville, North Carolina, 28472
Accellacare
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601-3834
India41 sites
HCG Hospitals
Ahmedabad, Gujarat, 380006
Dr. Jivraj Mehta Health Foundation
Ahmedabad, Gujarat, 380007
Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
Lifecare Hospital and Research Centre
Bangalore, Karnataka, 560092
Kanungo Institute of Diabetes Specialities Pvt Ltd
Bhubaneswar, Odisha, 751019
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086
Kg Hospital and Post Graduate Medical Institute
Coimbatore, Tamil Nadu, 641018
Goa Medical College
Goa, Maharashtra, 403 202
Apollo Excelcare Hospital, Guwahati
Guwahati, Assam, 781033
Apollo Excelcare Hospital
Guwahati, Assam, 781033
Osmania General Hospital
Hyderabad, A.P., 500 012
Sunshine Hospital
Hyderabad, Andhra Pradesh, 500016
Care Outpatient Centre
Hyderabad, Andhra Pradesh, 500034
Ramdev Rao Hospital
Hyderabad, Andhra Pradesh, 500072
Gandhi Hospital & Medical college
Hyderabad, Telangana, 500003
Osmania General Hospital
Hyderabad, Telangana, 500012
Ramdev Rao Hospital
Hyderabad, Telangana, 500072
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, 302006
SSKM
Kolkata, West Bengal, 700020
Apollo Gleneagles Hospital
Kolkata, West Bengal, 700054
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, 700054
Calicut Medical College
Kozhikode, Kerala, 673008
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
Christian Medical College and Hospital
Ludhiana, Punjab, 141008
Fortis Heart Institute and Multispeciality Hospital
Mohali, Punjab, 160062
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, 4000016
BYL Nair Hospital and T N Medical College Department of endo
Mumbai, Maharashtra, 400008
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016
BSES MG hospital
Mumbai, Maharashtra, 400058
Fortis Hospital Mulund
Mumbai, Maharashtra, 400078
Fortis Hospital, Mulund, Mumbai
Mumbai, Maharashtra, 400078
All India Institute of Medical Sciences
New Dehli, New Delhi, 110029
Lady Hardinge Medical College
New Delhi, 110001
North Delhi Diabetes Centre
New Delhi, 110085
chelleram Diabetes Institute
Pune, Maharashtra, 411021
Inamdar Multispeciality Hospital
Pune, Maharashtra, 411040
Christian Medical College Hospital, Vellore
Ranipet, Tamil Nadu, 632517
PGIMS Rohtak
Rohtak, Haryana, 124001
Jothydev's Diabetes & Research Center
Thriruvananthapuram, 695 032
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, 632004
Japan34 sites
The University of Tokyo Hospital, Diabetes and Metabolic
Bunkyo-ku, Tokyo, 113-8655
New Tokyo Heart Clinic_Matsudo-shi, Chiba,
Chiba, 271-0077
Ehime Prefectural Central Hospital
Ehime, 790-0024
Ehime Prefectural Central Hosp
Ehime, 790-0024
Fukui Prefectural Hospital
Fukui, 910-0846
Fukuoka Tokushukai Hospital
Fukuoka, 816-0864
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113
Naka Kinen Clinic
Ibaraki, 311-0113
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, 862-0976
Jinnouchi Hospital
Kumamoto, Kumamoto, Japan, 862-0976
Uji Tokushukai Medical Center_Cardiovascular Medicine
Kyoto, 611-0041
Kyoto University Hospital
Kyoto-shi, Kyoto, 606-8507
Shinden Higashi Clinic_Miyagi
Miyagi, 983-0039
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, 880-0034
Shinshu University Hospital
Nagano, 390-8621
Saiseikai Suita Hospital
Osaka, 564-0013
Osaka University Hospital_Osaka
Osaka, 565-0871
Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.
Osaka, 569-1045
Takatsuki Red Cross Hospital
Osaka, 569-1045
Nozaki Tokushukai Hospital_Internal medicine
Osaka, 574-0074
Saga University Hospital, Department of Cardiology
Saga-shi, Saga, 849-8501
Hanaoka Seishu Memorial Hosp._Cardiovascular Medicine
Sapporo-shi, Hokkaido, 062-0003
Kagawa Prefectural Central Hospital, Cardiovascular Medicine
Takamatsu-shi, Kagawa, 760-8557
Oyama East Clinic_Internal Medicine
Tochigi, 323-0022
Oyama East Clinic
Tochigi, 323-0022
Tokorozawa Heart Center
Tokorozawa-shi, Saitama, 356-1142
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027
Juntendo University Hospital_Tokyo
Tokyo, 113-8431
Juntendo University Hospital
Tokyo, 113-8431
Sugawara Clinic
Tokyo, 177-0041
Minamino Cardiovascular Hospital_Cardiovascular medicine
Tokyo, 192-0918
Minamino Cardiovascular Hospital
Tokyo, 192-0918
Tokyo Nishi Tokushukai Hospital_Cardiovascular medicine
Tokyo, 196-0003
Tokyo Nishi Tokushukai Hospital
Tokyo, 196-0003
Russia21 sites
City Hospital #5
Barnaul, 656045
Kazan Federal University
Kazan', 420012
LLC "Clinic of Aesthetic Medicine & Laser Technologies"
Kazan', 420111
SAHI Kuzbass Hospital(former Regional clinical hospital)
Kemerovo, 650066
Friendship University of Russia
Moscow, 117292
Setchenov First Moscow State Medical University
Moscow, 119435
State Novosibirsk regional clinical hospital
Novosibirsk, 630087
Limited Law Company "Healthy Family" Medicine Center"
Novosibirsk, 630099
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza, 440052
SPb SBHI City Outpatient clinic #37
Saint Petersburg, 191119
Aurora MedFort LLC
Saint Petersburg, 194156
City Consultative & Diagnostic Centre #1
Saint Petersburg, 194354
SPb SBHI City Multifield Hospital #2
Saint Petersburg, 194354
Consultative & Diagnostic Center with a Outpatient Hospital
Saint Petersburg, 197110
Regional clinical cardiology dispensary
Saratov, 410039
Saratov regional clinical hospital
Saratov, 410053
Siberian State Medical University
Tomsk, 634050
Tumen State Medical University
Tyumen, Russia, 625023
Ulianovsk Regional Clinical Hospital
Ulyanovsk, 432063
Yaroslavl Regional Hospital
Yaroslavl, 150062
Polyclinic #2 in Yoshkar-Ola
Yoshkar-Ola, 424004
United Kingdom21 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Crouch Oak Family Practice
Addlestone, Surrey, KT15 2BH
Royal Victoria Hospital
Belfast, BT12 6BA
The Health Centre
Bradford on Avon, BA15 1DQ
Southmead Hospital
Bristol, BS10 5NB
Addenbrooke's Hospital_Cambridge
Cambridge, CB2 0QQ
Hathaway Surgery
Chippenham, SN15 1HP
WISDEM Centre
Coventry, CV2 2DX
Western General Hospital
Edinburgh, EH4 2XU
Glasgow Royal Infirmary
Glasgow, G31 2ER
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Harrogate District Hospital
Harrogate, HG2 7SX
Burbage Surgery
Hinckley, LE10 2SE
Hull Royal Infirmary
Hull, HU3 2JZ
Royal Free - Diabetes
London, NW3 2QG
North Manchester General Hospital - Diabetes Centre
Manchester, M8 5RB
Norfolk and Norwich University Hospital
Norfolk, NR4 7UQ
University Dept of Medicine, Derriford Hospital, Plymouth
Plymouth, PL6 8DH
East Surrey Hospital
Redhill, RH1 5RH
The Staploe Medical Centre
Soham, CB7 5JD
Joint Clinical Research Facility - Swansea
Swansea, SA2 8PP
Canada18 sites
LMC Diabetes & Endocrinology (Barrie)
Barrie, Ontario, L4N 7L3
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, L6S 0C6
Aggarwal and Assoc Ltd.
Brampton, Ontario, L6T 0G1
C-endo Diab Endo Clin Calgery
Calgary, Alberta, T2V 4J2
LMC Clinical Res Thornhill
Concord, Ontario, L4K 4M2
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, B3H 1V7
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8M 1K7
McMaster University
Hamilton, Ontario, L8N 3Z5
My Endo Diabetes & Endo Cent
Markham, Ontario, L3P 7P2
Manna Research Mirabel
Mirabel, Quebec, J7J 2K8
Applied Med Inf Res
Montreal, Quebec, H4A 3T2
CHU de Quebec-Universite Laval
Québec, G1V 4G2
Bluewater Clin Res Group, Inc.
Sarnia, Ontario, N7T 4X3
Bluewater Clin Res Group,Inc
Sarnia, Ontario, N7T 4X3
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
UHN-Toronto General Hospital
Toronto, Ontario, M5G 2N2
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2
Vancouver General Hospital_Vancouver_0
Vancouver, British Columbia, V5Z 1M9
South Africa15 sites
Diabetes Care Centre & CDE Centre
Benoni, Gauteng, 1501
Dr H Bacus
Berea, KwaZulu-Natal, 4091
Diabetes Clinical Trials Unit
Cape Town, Western Cape, 7925
UCT Clinical Research Centre
Cape Town, Western Cape, 7925
Dr A Amod
Durban, KwaZulu-Natal, 4092
Dr T Padayachee
Durban, KwaZulu-Natal, 4170
Dr Pillay's Rooms
Durban, KwaZulu-Natal, 4450
Peermed Clinical Trial Centre
Johannesburg, Gauteng, 1619
Soweto Clinical Trial Centre
Johannesburg, Gauteng, 1818
Deepak Lakha
Johannesburg, Gauteng, 1820
Hemant Makan
Johannesburg, Gauteng, 1827
Deepak Lakha
Johannesburg, Gauteng, 1829
Centre for Diabetes
Johannesburg, Gauteng, 2198
Dr Seeber
Pretoria, Gauteng, 0083
Prof P. Joshi
Pretoria, Gauteng, 0181
Spain15 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital Comarcal de Antequera
Antequera, 29200
Hospital del Mar
Barcelona, 08003
Hospital Público da Mariña
Burela de Cabo, 27880
Hospital Reina Sofia
Córdoba, 14004
Hospital Univ. de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010
Hospital Ribera Polusa
Lugo, 27004
Hospital Clinico Virgen de la Victoria
Málaga, 29006
Hospital Quirón
Pozuelo de Alarcón, 28223
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, 28223
Hospital Virgen del Camino - Sanlúcar de Barrameda
Sanlúcar de Barrameda, 11540
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706
Hospital Virgen de la Macarena
Seville, 41009
Turkey (Türkiye)15 sites
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
Adana, 01000
Gulhane Egitim Arastirma Hastanesi
Ankara, 06010
Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Kardiyoloji
Bursa, 16310
T.C. Saglik Bakanligi Bursa Il Saglik Mudurlugu Yuksek Ihtıs
Bursa, 16310
Atatürk Üniversitesi Araştırma Hastanesi- Endokrinoloji
Erzurum, 25240
Eskişehir Osmangazi Üniversitesi Sağlık, Uygulama ve Araştırma Hastanesi
Eskişehir, 26040
Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
Hatay, 31060
Haseki Egitim ve Arastirma Hastanesi_ISTANBUL
Istanbul, 34096
Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi
Istanbul, 34303
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, 34722
Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-Endokrinoloji
Izmir, 35340
Erciyes Üniversitesi Hastanesi- Nefroloji
Kayseri, 38039
Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
Sivas, 58140
Karadeniz University School of Medicine-Adult Endocrinology
Trabzon, 61080
Adana Şehir Eğitim ve Araştırma Hastanesi
Yüreğir/Adana, 1370
Germany14 sites
Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden)
Dresden, 01277
Uniklinik TU Dresden - Med. Klinik III
Dresden, 01307
Praxis Dr. med. M. Esser
Essen, 45219
Zentrum für klinische Forschung, Dr. med. Lüdemann
Falkensee, 14612
Diabetologische Schwerpunktpraxis Harburg- Dr. med.Paschen,
Hamburg, 21073
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, 22041
Praxisgemeinschaft Jerichow
Jerichow, 39319
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, 49808
Die Praxis am Ludwigsplatz
Ludwigshafen, 67059
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758
Praxis Dr. med. Wenzl-Bauer
Rehlingen-Siersburg, 66780
VvP Kliniken gGmbH Marienhospital Stuttgart - Innere Medizin I
Stuttgart, 70199
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
Witten, 58455
Italy13 sites
A.O.U. Consorziale Policlinico di Bari
Bari, BA, 70124
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Cz, 88100
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti Scalo, 66100
Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
Lucca, LU, 55100
Istituto Scientifico San Raffaele
Milan, MI, 20132
Centro Cardiologico Monzino
Milan, 20138
Università Federico II Dip. di Med. Clinica e Chirurgia Ed 1
Naples, 80131
Azienda Ospedaliera di Padova Malatt.Metab
Padova, 35128
Dip. di Medicina Interna Policlinico Universitario Palermo
Palermo, 90127
Policlinico Universitario Paolo Giaccone
Palermo, 90127
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, Umbria, 06129
Policlinico Umberto I Seconda Clinica Medica
Roma, RM, 00161
Policlinico Universitario Tor Vergata
Roma, 00133
Malaysia13 sites
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460
Hospital Sultanah Bahiyah
Alor Star, 05460
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586
Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan
Kota Bharu, Kelantan, 16150
Sarawak Heart Centre
Kota Samarahan, Sarawak, 94300
Sarawak General Hospital
Kuching, 93586
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
Hospital Miri
Miri, Sarawak, 98000
Hospital Putrajaya
Putrajaya, Putrajaya, 62250
Hospital Miri
Sarawak, 98000
Hospital Tuanku Jaafar
Seremban, 70300
University Technology MARA (UiTM) - Puncak Alam
Sungai Buloh, Selangor, 47000
University Technology MARA (UiTM) - Sg Buloh
Sungai Buloh, Selangor, 47000
Argentina12 sites
DIM Clinica Privada
Buenos Aires, B1704ETD
Centro Medico Lebensohn
Buenos Aires, B6000BHA
Hospital Italiano
Buenos Aires, C1181ACH
Centro de Investigaciones Metabólicas
Capital Federal, C1056ABI
Centro Diabetologico Cordoba Dr. Waitman
Córdoba, 5000
Centro médico privado Cemaic
Córdoba, 5008
Instituto Médico DAMIC
Córdoba, X5003DCE
Centro Médico Privado San Vicente Diabetes
Córdoba, X5006IKK
Centro Médico CIMEL
Lanús Este, Buenos Aires, B1824KAJ
Centro Médico CIMEL
Lanús Este, B1824KAJ
Instituto de Investigaciones Clinicas
Mar del Plata, B7600FZN
Sanatorio Britanico S.A.
Rosario, Santa Fe, S2000CVB
Slovakia12 sites
Metabolicke Centrum MUDr. Katariny Raslovej s.r.o.
Bratislava, 831 01
MediTask, s.r.o
Bratislava, 83103
Nemocnica akademika L. Derera, UNB
Bratislava, 833 05
HUMAN-CARE, s.r.o.
Košice, 040 01
CARDIO D&R, s.r.o.
Košice, 040 22
Nemocnica Krompachy spol. s r.o Diabetol. amb. MD Gmitrov
Krompachy, 05342
Diabetologicka ambulancia MUDr. Katarina Plevova, s.r.o.
Nitra, 949 01
DENTAVIA s.r.o.
Poprad, 05801
MUDr. Jan Culak, s.r.o.
Prievidza, 97101
Kardiologicka a interna ambulancia
Rimavská Sobota, 97901
Tatratrial s.r.o.
Rožňava, 04801
IRIDIA s.r.o.
Vrútky, 038 61
Israel11 sites
Rambam MC - Diabetes and obesity center of excellence
Haifa, 31096
Hadassah Ein Karam MC - Diabetes Unit
Jerusalem, 91120
Clalit HMO Hamoshava Jerusalem
Jerusalem, 93106
Meir MC - Diabetes unit
Kfar Saba, 44281
Western Galilee MC - Institute of Diabetes
Nahariya, 22100
Rabin MC Beilinson - Endo unit
Petah Tikva, 49100
Sourasky MC - Institute of Endocrinology, metabolism and hypertension
Tel Aviv, 6423906
Endrocrinolgy Clinic - Sheba Medical Center
Tel Litwinsky, 52621
Sheba MC - Endocrinology Clinic
Tel Litwinsky, 52621
Sheba MC - Cardiology Clinical Research Unit
Tel Litwinsky, 5265601
Sheba Medica Center - Clinical Research Unit
Tel Litwinsky, 5265601
Romania11 sites
CMI Dr. Pletea Noemi SRL
Bacau, 600154
Diabet Med SRL
Bucharest, 051811
Clinic of Diabetes Cluj
Cluj-Napoca, Cluj, 400006
Clinical Emergency Sf. Apostol Andrei Hospital
Galati, 800578
Spitalul Clinic Judetean de Urgente Sf. Spiridon
Iași, 700111
Novus Medical Clinica SRL
Ploieşti, Prahova, 100018
CMI Dr. Busegeanu Mihaela Magdalena
Ploieşti, Prahova, 100342
SC Gensan SRL, Policlinica ASTRA
Sibiu, 550371
Spitalul Judetean de Urgenta Targoviste
Targoviste, Dâmbovița County, 130083
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, Mureș County, 540136
Sc Mediab Srl
Târgu Mureş, Mureș County, 540142
Thailand11 sites
King Chulalongkorn Memorial Hospital_Endocrinology
Bangkok, 10330
Police General Hospital
Bangkok, 10330
Phramongkutklao Hospital
Bangkok, 10400
Rajavithi Hospital_Diabetes and Endocrinology
Bangkok, 10400
Rajavithi Hospital
Bangkok, 10400
Ramathibodi Hospital-Cardiovascular metabolic Center
Bangkok, 10400
SI-Dvs of Endocrinology
Bangkok, 10700
Siriraj Hospital-Cardio
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital_Endocrilogy
Chiang Mai, Mueang Chiang Mai, 50200
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, 30000
Songklanagarind Hospital
Songkhla, Had-Yai, 90110
Croatia10 sites
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
Krapinske Toplice, 49217
Klinicki bolnicki centar Osijek
Osijek, 31 000
Opca bolnica Pula
Pula, 52100
KBC Rijeka, Zavod za endokrinologiju
Rijeka, 51000
KBC Split / Krizine / Dijabetes
Split, 21 000
Opca bolnica Varazdin_Endocrinology
Varaždin, 42 000
Opca bolnica Zadar_Endocrinology
Zadar, 23000
Poliklinika Solmed
Zagreb, City of Zagreb, 10000
KB Merkur - Sveucilisna klinika Vuk Vrhovac
Zagreb, 10 000
KB Dubrava, Zavod za endokrinologiju i dijabetes
Zagreb, 10000
Czechia10 sites
Fakultní nemocnice U sv. Anny v Brně
Brno, 602 00
Intendia klinika
Chrudim, 53701
FN Hradec Kralove
Hradec Králové, 500 05
Diabetologicka a Interni Ambulance MUDr. Jan Vrkoc s.r.o.
Moravská Ostrava, 70200
Ambulance DIA - INTERNA s.r.o.
Ostrava, 73000
Diabetologicka ambulance Plzen
Pilsen, 30100
MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
Pilsen, 326 00
MUDr. Jitka Zemanova diabetologie a interna
Plzeň - Východní Předměstí, 32600
DIALINE s.r.o.
Plzeň 3, 301 00
Institut klinicke a experimentalni mediciny_Praha
Prague, 14021
Mexico10 sites
Centro de Investigación Cardiometabólica de Aguascalientes
Aguascalientes, 20230
Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC
Guadalajara, Jalisco, 44600
Consultorio Arechavaleta Granell María del Rosario
Guadalajara, Jalisco, 44650
Investigación Médica Sonora S.C.
Hermosillo, Sonora, 83280
EME Red Hospitalaria
Mérida, Yucatán, 97000
Medical Care and Research S. A de C.V
Mérida, Yucatán, 97070
Internal Medicine Clin Trials
Monterrey, Nuevo León, 64020
Cardiolink Clin Trials S.C.
Monterrey, Nuevo León, 64060
Unidad Medica para la Salud Integral (UMSI)
San Nicolás de los Garza, Nuevo León, 66465
Centro de Atención Integral al Paciente con Diabetes
Tlalpan, México, D.F., 14080
Netherlands10 sites
Meander Medisch Centrum
Amersfoort, 3813 TZ
Amsterdam UMC Lokatie VUMC
Amsterdam, 1081 HV
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, 7334 DZ
Reinier de Graaf Gasthuis
Delft, 2625 AD
Maxima Medisch Centrum
Eindhoven, 5631 BM
Martini Ziekenhuis
Groningen, 9728 NT
Bethesda Diabetes Research Center en Bethesda ziekenhuis
Hoogeveen, 7909 AA
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX
Radboudumc
Nijmegen, 6525 GA
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Ukraine10 sites
Cherkasy Regional Clinical Hospital - Endocrinology department
Cherkasy, 18009
Chernivtsi Regional Clinical Hospital - Endo Outpatient department
Chernivtsi, 58022
Dnipropetrovsk Regional Clinical Hospital named after І.І.Mechnikov - Endocrinology therapy department
Dnipro, 49005
Kyiv Railway Clinical Hospital #2 - day care department
Kyiv, 03049
Centre of Innovative Medical Technologies of NASU - Therapeutic and Endocrinology Department
Kyiv, 04053
Lviv Regional Clinical Diagnostic and Treatment Endocrinology Centre - Outpatient department
Lviv, 79010
Odesa Regional Clinical Hospital - Endocrinology department
Odesa, 65025
City Clinical Hospital #1 (Poltava) - Therapeutic department
Poltava, 36039
Transcarpathian Regional Clinical Hospital named after A.Novak - Endocrinology department
Uzhhorod, 88000
Zhytomir Regional Clinical Hospital - Endocrinology department
Zhytomyr, 10002
Brazil9 sites
Hospital do Coração do Brasil
Brasília, Federal District, 70390-700
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080
i9 Pesquisas Clínicas
Campinas, São Paulo, 13092-133
Cline Research Center
Curitiba, Paraná, 80030-480
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
Curitiba, Paraná, 80045-110
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
Instituto de Pesquisa Clinica (IPEC)
São Paulo, São Paulo, 01223-001
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, 01228-200
Belgium8 sites
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
Bonheiden, 2820
UZ Antwerpen - UZA - Department of Endocrinology
Edegem, 2650
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, 2650
UZ Gent - Endocrinologie - Diabetologie
Ghent, 9000
AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
Kortrijk, 8500
UZ Leuven - Endocrinology
Leuven, 3000
AZ Delta - Roeselare - Diabeteskliniek
Roeselare, 8800
AZ Delta - Roeselare
Roeselare, 8800
China8 sites
Peking University People's Hospital-Endocrinology
Beijing, Beijing Municipality, 100044
Cangzhou People's Hospital-Endocrinology
Cangzhou, Hebei, 061000
Cangzhou People's Hospital
Cangzhou, Hebei, 061000
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu, 213003
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, 250013
Shanghai Fifth People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, 200240
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, 212001
The Affiliated Hospital of Jiangsu University_Zhenjiang
Zhenjiang, Jiangsu, 212001
France8 sites
Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz
Besançon, 25030
Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
Dijon, 21079
Les Hopitaux de Chartres-Hopital Louis Pasteur
Le Coudray, 28630
Assistance Publique Hopitaux de Marseille-Hopital de La Conception
Marseille, 13005
Centre Hospitalier de Narbonne
Narbonne, 11100
Ap-Hp-Hopital Bichat-Claude Bernard-1
Paris, 75877
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
Pessac, 33600
Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-1
Strasbourg, 67098
South Korea8 sites
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Hanyang University GURI Hospital
Gyeonggi-do, 471-101
Korea University Anam Hospital
Seoul, 02841
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Seoul Saint Mary's Hospital
Seoul, 06591
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
Nowon Eulji Medical Center, Eulji University
Seoul, 139-827
Serbia7 sites
CHC Zvezdara, Clinical department for endocrinology
Belgrade, 11000
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
Kragujevac, 34000
Clinical Centre Nis, Endocrinology, Diabetes and Metabolism
Niš, 18000
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, 21000
Policlinic for diabetes
Zaječar, 19000
Algeria6 sites
Internal medicine department
Algiers, 16000
endocrino-diabetology department, Hospital IBN BADIS.
Constantine, 25000
Internal Medecine department CHU Ibn Badis
Constantine, 25000
EHU 1st November 1954
Oran, 31000
Internal Medicine departement CHU Oran
Oran, 31000
Department of internal of medicine, CHU Setif
Sétif, 19000
Colombia6 sites
Clinica de la Costa
Barranquilla, Atlántico, 80020
Clinica de la Costa
Barranquilla, 80020
Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia
Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander Department, 681012
Fundacion Valle del Lili
Cali, Valle del Cauca Department, 760032
Fundación Centro de Obesidad y Metabolismo COMETA
Pasto, 520002
Fundación Hospital Universidad del Norte
Soledad, Barranquilla, 83001
Austria5 sites
Univ.-Klinik für Innere Medizin
Graz, 8036
Medizinische Universität Innsbruck
Innsbruck, 6020
Fließer-Görzer [Ordination]
Saint Stefan, 8511
Klinik Hietzing
Vienna, 1130
Klinik Ottakring
Vienna, 1160
Denmark5 sites
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, 8200
Bispebjerg Hospital, IC-Forskning
Copenhagen, 2400
Hillerød Endokrinologisk amb. H0652
Hillerød, 3400
Slagelse Sygehus Ambulatorium for hjertesygdomme
Slagelse, 4200
Svendborg Sygehus - Endokrinologisk afdeling
Svendborg, 5700
Taiwan3 sites
Changhua Christian Hospital_Metabolic Dept.
Changhua, 500
Chung Shan Medical University Hospital
Taichung, 402
Chang Gung Medical Foundation - Linkou Branch
Taoyuan, 333
About this study
Official title: Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide, Placebo (semaglutide)
- 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.
SemaglutideDrug
Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state
Placebo (semaglutide)Drug
Placebo tablets to be taken with water at the same time every morning in a fasting state
| Study group | Role | What they receive |
|---|---|---|
| Oral semaglutide | Experimental | One tablet daily for 3.5 to 5 years Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | One tablet daily for 3.5 to 5 years Receives: Drug: Placebo (semaglutide) |
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 a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal Stroke
Number of participants with first occurrence of EAC (event adjudication committee) confirmed major adverse cardiovascular event (MACE), a composite end-point. i.e., from time of randomization to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction and non-fatal stroke combined data 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.
Measured: From randomisation (week 0) up to week 265
Secondary outcomes (24)
Number of Participants From Randomization to First Occurrence of CV Death;Renal Death;Onset of Persistent≥50% Reduction in eGFR(CKD-EPI);Onset of Persistent eGFR(CKD-EPI)<15 mL/Min/1.73m^2;Initiation of Chronic Renal Replacement Therapy
Number of participants with first occurrence of a composite endpoint. i.e., from time of randomization to first occurrence of CV death, renal death, onset of persistent greater than or equal to (≥) 50% reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease epidemiology collaboration CKD-EPI), onset of persistent eGFR (CKD-EPI) less than (<)15 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation) combined data 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomization to Time of Occurrence of CV Death
Number of participants from time of randomization to time to occurrence of EAC confirmed CV death 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomization to First Occurrence of Major Adverse Limb Events (MALE), a Composite Endpoint Consisting of: Acute Limb Ischemia Hospitalisation/Chronic Limb Ischemia Hospitalisation
Number of participants from randomization to first occurrence of EAC confirmed major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation combined data 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of an Expanded MACE Composite Endpoint Consisting of: CV Death/Non-fatal Myocardial Infarction/ Non-fatal Stroke/Coronary Revascularisation/Unstable Angina Pectoris Requiring Hospitalisation
The number of participants from randomisation to first occurrence of an expanded MACE composite endpoint consisting of: CV death/non-fatal myocardial infarction/ non-fatal stroke/coronary revascularisation/unstable angina pectoris requiring hospitalisation combined data 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of a Composite Endpoint Consisting of : All-cause Death/ Non-fatal MI/ Non-fatal Stroke
The number of participants from randomisation to first occurrence of EAC confirmed composite endpoint consisting of : all-cause death/ non-fatal MI/ non-fatal stroke combined data 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of a Composite Heart Failure Endpoint Consisting of: CV Death/Heart Failure Requiring Hospitalisation/Urgent Heart Failure Visit
Number of participants from randomisation to first occurrence of EAC confirmed composite heart failure endpoint consisting of: CV death/heart failure requiring hospitalisation/urgent heart failure visit combined data 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
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomization to First Occurrence of CKD Endpoint:Renal Death;Onset of Persistent≥50% Reduction in eGFR (CKD-EPI);Onset of Persistent eGFR(CKD-EPI)<15 mL/Min/1.73 m^2;Initiation of Chronic Renal Replacement Therapy
The number of participants from randomization to first occurrence of CKD endpoint:renal death;onset of persistent≥50% reduction in eGFR (CKD-EPI);onset of persistent eGFR(CKD-EPI)<15 mL/min/1.73 m^2;initiation of chronic renal replacement therapy combined data 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to Time to Occurrence of All-cause Death
The number of participants from randomisation to time to occurrence of EAC confirmed all-cause death 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Non-fatal Myocardial Infarction (MI)
The number of participants from randomisation to first occurrence of EAC confirmed non-fatal MI 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Non-fatal Stroke
The number of participants from randomisation to first occurrence of EAC confirmed non-fatal stroke 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Heart Failure Requiring Hospitalisation or Urgent Heart Failure Visit
The number of participants from randomisation to first occurrence of EAC confirmed heart failure requiring hospitalisation or urgent heart failure visit 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Coronary Revascularisation
The number of participants from randomisation to first occurrence of coronary revascularisation 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Unstable Angina Requiring Hospitalisation
The number of participants from randomisation to first occurrence of EAC confirmed unstable angina requiring hospitalisation 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to Time to Occurrence of Renal Death
The number of participants from randomisation to time to occurrence of EAC confirmed renal death 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Onset of Persistent 50% or More Reduction in eGFR
The number of participants from randomisation to first occurrence of onset of persistent 50% or more reduction in eGFR during in-trial period were observed. 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Onset of Persistent eGFR (CKD-EPI) Below 15 mL/Min/1.73 m^2
The number of participants from randomisation to first occurrence of onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2 during in-trial period were observed. 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Initiation of Chronic Renal Replacement Therapy (Dialysis or Kidney Transplantation)
The number of participants from randomisation to first occurrence of EAC confirmed initiation of chronic renal replacement therapy (dialysis or kidney transplantation) during in-trial period were presented. 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Acute Limb Ischemia
The number of participants from randomisation to first occurrence of EAC confirmed acute limb ischaemia hospitalization during in-trial period were presented. 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of Chronic Limb Ischemia Hospitalisation
The number of participants from randomisation to first occurrence of EAC confirmed chronic limb ischaemia hospitalization during in-trial period were presented. 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.
Measured: From randomisation (week 0) up to week 265
Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)
Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported during in trial period. eGFR was calculated using the CKD-EPI formula. 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.
Measured: From randomisation (week 0) up to week 260
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from baseline (Week 0) up to Week 104 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.
Measured: Baseline (Week 0), Week 104
Change From Baseline in Body Weight
Change in body weight from baseline (Week 0) up to Week 104 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.
Measured: Baseline (Week 0), Week 104
Number of Severe Hypoglycaemic Episodes
The number of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) observed during the in-trial period were reported in this endpoint. 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.
Measured: From randomisation (week 0) up to week 265
Number of Participants From Randomisation to First Occurrence of a Severe Hypoglycaemic Episode
The number of participants from randomisation to first occurrence of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) 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.
Measured: From randomisation (week 0) up to week 265
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start17 Jun 2019
- Primary completion23 Aug 2024
- Study completion23 Aug 2024
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 (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914326
- Sponsor's protocol ID
- EX9924-4473
- Other IDs
- 2018-003141-42, U1111-1218-5368, 2018
- Acronym
- SOUL
- Status last verified
- Nov 2025
- First submitted
- 11 Apr 2019
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Mulvagh SL, Inzucchi SE, Marx N, Poulter NR, Deanfield JE, Pop-Busui R, Emerson SS, Mann JFE, Engelmann MDM, Hovingh GK, Mandavya K, Davicevic-Elez Z, Jeppesen OK, Lorenzatti A, Oguz A, Mankovsky B, Deerochanawong C, Gorgojo-Martinez JJ, Ji L, Bain SC, McGuire DK, Buse JB; SOUL Study Group. Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes: A Post Hoc Secondary Analysis of the SOUL Randomized Clinical Trial. JAMA Cardiol. 2026 May 1;11(5):427-437. doi: 10.1001/jamacardio.2026.0245.
PubMed 41879791Pop-Busui R, Rasmussen S, Deanfield JE, Buse JB, Marx N, Mulvagh SL, Inzucchi SE, Mann JFE, Emerson SS, Poulter NR, Engelmann MDM, Hovingh GK, Bayer Tanggaard K, Birkenfeld AL, Connelly KA, Haluzik M, Cavender MA, Kellerer M, Jhund PS, Gregersen S, Nielsen OW, Lam CSP, McGuire DK; SOUL Study Group. Oral Semaglutide and Heart Failure Outcomes in Persons With Type 2 Diabetes: A Secondary Analysis of the SOUL Randomized Clinical Trial. JAMA Intern Med. 2026 Apr 1;186(4):426-436. doi: 10.1001/jamainternmed.2025.7774.
PubMed 41627802Mann JFE, Marx N, Deanfield JE, Emerson SS, Inzucchi SE, McGuire DK, Mulvagh SL, Pop-Busui R, Poulter NR, Engelmann MDM, Hovingh GK, Belmar N, Idorn T, Jeppesen OK, Birkenfeld AL, Amod A, Mankovsky B, Desouza C, Gorgojo-Martinez JJ, Arechavaleta R, Tu ST, Buse JB; SOUL Study Group*. Impact of Oral Semaglutide on Kidney Outcomes in People With Type 2 Diabetes: Results From the SOUL Randomized Trial. Diabetes Care. 2026 Feb 1;49(2):257-265. doi: 10.2337/dc25-1080.
PubMed 41380027Borlaug BA, Holse C, Jung MH, Lincoff AM, Mulvagh SL, Staerk-Ostergaard J, Tuttle KR, Petrie MC. Prevalence and Associations of Systemic Inflammation in Heart Failure Across the Spectrum of Ejection Fraction. JACC Heart Fail. 2026 Feb;14(2):102712. doi: 10.1016/j.jchf.2025.102712. Epub 2025 Oct 16.
PubMed 41099689McGuire DK, Marx N, Mulvagh SL, Deanfield JE, Inzucchi SE, Pop-Busui R, Mann JFE, Emerson SS, Poulter NR, Engelmann MDM, Ripa MS, Hovingh GK, Brown-Frandsen K, Bain SC, Cavender MA, Gislum M, David JP, Buse JB; SOUL Study Group. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. N Engl J Med. 2025 May 29;392(20):2001-2012. doi: 10.1056/NEJMoa2501006. Epub 2025 Mar 29.
PubMed 40162642Marx N, Deanfield JE, Mann JFE, Arechavaleta R, Bain SC, Bajaj HS, Bayer Tanggaard K, Birkenfeld AL, Buse JB, Davicevic-Elez Z, Desouza C, Emerson SS, Engelmann MDM, Hovingh GK, Inzucchi SE, Jhund PS, Mulvagh SL, Pop-Busui R, Poulter NR, Rasmussen S, Tu ST, McGuire DK; SOUL Study Group. Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial. Circulation. 2025 Jun 10;151(23):1639-1650. doi: 10.1161/CIRCULATIONAHA.125.074545. Epub 2025 Mar 29.
PubMed 40156843Natale 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