A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— SOUL  

Official title:

Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03914326
• Other study ID #: EX9924-4473
• Secondary ID: 2018-003141-42U1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 17, 2019
• Est. completion date: July 29, 2024

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9642
• Est. completion date: July 29, 2024
• Est. primary completion date: July 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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):

a) 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide
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)
Placebo tablets to be taken with water at the same time every morning in a fasting state

Locations

Country	Name	City	State
Algeria	Internal medicine department	Algiers
Algeria	endocrino-diabetology department, Hospital IBN BADIS.	Constantine
Algeria	Internal Medecine department CHU Ibn Badis	Constantine
Algeria	EHU 1st November 1954	Oran
Algeria	Internal Medicine departement CHU Oran	Oran
Algeria	Department of internal of medicine, CHU Setif	Setif
Argentina	Centro Medico Lebensohn	Buenos Aires
Argentina	DIM Clinica Privada	Buenos Aires
Argentina	Hospital Italiano	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas	Capital Federal
Argentina	Centro Diabetologico Cordoba Dr. Waitman	Cordoba
Argentina	Centro médico privado Cemaic	Córdoba
Argentina	Centro Médico Privado San Vicente Diabetes	Córdoba
Argentina	Instituto Médico DAMIC	Córdoba
Argentina	Centro Médico CIMEL	Lanus Este	Buenos Aires
Argentina	Centro Médico CIMEL	Lanus Este
Argentina	Instituto de Investigaciones Clinicas	Mar del Plata
Argentina	Sanatorio Britanico S.A.	Rosario, Santa Fe
Austria	Univ.-Klinik für Innere Medizin	Graz
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	Fließer-Görzer [Ordination]	Saint Stefan
Austria	Klinik Hietzing	Wien
Austria	Klinik Ottakring	Wien
Belgium	Imeldaziekenhuis - Bonheiden - Department of Endocrinology	Bonheiden
Belgium	UZ Antwerpen - UZA - Department of Endocrinology	Edegem
Belgium	UZA - UZ Antwerpen - Department of Endocrinology	Edegem
Belgium	UZ Gent - Endocrinologie - Diabetologie	Gent
Belgium	AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie	Kortrijk
Belgium	UZ Leuven - Endocrinology	Leuven
Belgium	AZ Delta - Roeselare - Diabeteskliniek	Roeselare
Brazil	Hospital do Coração do Brasil	Brasilia	Distrito Federal
Brazil	Instituto de Pesquisa Clínica de Campinas	Campinas	Sao Paulo
Brazil	Loema Med e Bem Estar Centro Especializado em Cardiologia	Campinas	Sao Paulo
Brazil	Cline Research Center	Curitiba	Parana
Brazil	Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV	Curitiba	Parana
Brazil	Hospital São Vicente de Paulo	Passo Fundo	Rio Grande Do Sul
Brazil	CPCLIN - Centro de Pesquisas Clínicas	São Paulo	Sao Paulo
Brazil	CPQuali Pesquisa Clínica Ltda	São Paulo	Sao Paulo
Brazil	Instituto de Pesquisa Clinica (IPEC)	São Paulo	Sao Paulo
Canada	LMC Diabetes & Endocrinology (Barrie)	Barrie	Ontario
Canada	Aggarwal and Assoc Ltd.	Brampton	Ontario
Canada	LMC ClinRsrh Inc.Brampton	Brampton	Ontario
Canada	C-endo Diab Endo Clin Calgery	Calgary	Alberta
Canada	LMC (Thornhill)	Concord	Ontario
Canada	Nova Scotia Hlth Halifax	Halifax	Nova Scotia
Canada	Hamilton Med Res Group	Hamilton	Ontario
Canada	McMaster University	Hamilton	Ontario
Canada	Manna Research Mirabel	Mirabel	Quebec
Canada	Applied Med Inf Res	Montreal	Quebec
Canada	CHU de Quebec-Universite Laval	Quebec
Canada	Bluewater Clin Res Group, Inc.	Sarnia	Ontario
Canada	Bluewater Clin Res Group,Inc	Sarnia	Ontario
Canada	Diabetes Heart Research Centre	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	UHN-Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital_Vancouver_0	Vancouver	British Columbia
China	Peking University People's Hospital	Beijing	Beijing
China	Cangzhou People's Hospital	Cangzhou	Hebei
China	Changzhou No.2 People's Hospital, Yanghu Branch	Changzhou	Jiangsu
China	Jinan Central Hospital	Ji'nan	Shandong
China	Jinan Central Hospital Affiliated to Shandong University	Jinan	Shandong
China	Shanghai Fifth People's Hospital	Shanghai	Shanghai
China	The Affiliated Hospital of Jiangsu University_Zhenjiang	Zhenjiang	Jiangsu
Colombia	Clinica de la Costa	Barranquilla
Colombia	Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia	Bucaramanga-piedecuesta, Valle Del Menzuli - Santander	Santander
Colombia	Fundacion Valle del Lili	Cali
Colombia	Fundación Centro de Obesidad y Metabolismo COMETA	Pasto
Colombia	Fundación Hospital Universidad del Norte	Soledad	Barranquilla
Croatia	Specijalna bolnica Krapinske Toplice - Endokrinologija	Krapinske Toplice
Croatia	Klinicki bolnicki centar Osijek	Osijek
Croatia	Opca bolnica Pula	Pula
Croatia	KBC Rijeka, Zavod za endokrinologiju	Rijeka
Croatia	KBC Split / Krizine / Dijabetes	Split
Croatia	Opca bolnica Varazdin	Varazdin
Croatia	Opca bolnica Zadar	Zadar
Croatia	KB Dubrava, Zavod za endokrinologiju i dijabetes	Zagreb
Croatia	KB Merkur - Sveucilisna klinika Vuk Vrhovac	Zagreb
Croatia	Poliklinika Solmed	Zagreb	Grad Zagreb
Czechia	University Hospital U sv. Anny	Brno
Czechia	Intendia klinika	Chrudim
Czechia	FN Hradec Kralove	Hradec Kralove
Czechia	Diabetologicka a Interni Ambulance MUDr. Jan Vrkoc s.r.o.	Moravska Ostrava
Czechia	Ambulance DIA - INTERNA s.r.o.	Ostrava
Czechia	Diabetologicka ambulance Plzen	Plzen
Czechia	MUDr. Jitka Zemanova diabetologie a interna	Plzen - Východní Predmestí
Czechia	DIALINE s.r.o.	Plzen 3
Czechia	Institut klinicke a experimentalni mediciny_Praha	Praha
Denmark	Aarhus Universitetshospital, Steno Diabetes Center Aarhus	Aarhus N
Denmark	Hillerød Endokrinologisk amb. H0652	Hillerød
Denmark	Bispebjerg Hospital, IC-Forskning	København
Denmark	Slagelse Sygehus Ambulatorium for hjertesygdomme	Slagelse
Denmark	Svendborg Sygehus	Svendborg
France	Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz	Besançon cedex
France	Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage	DIJON cedex
France	Les Hopitaux de Chartres-Hopital Louis Pasteur	Le Coudray
France	Assistance Publique Hopitaux de Marseille-Hopital de La Conception	Marseille
France	Centre Hospitalier de Narbonne	Narbonne
France	Ap-Hp-Hopital Bichat-Claude Bernard-1	Paris
France	Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2	Pessac
France	Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-1	Strasbourg
Germany	Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH	Dresden
Germany	Medizinische Klinik III Studienzentrum für Stoffwechselerkrankungen der TU Dresden	Dresden
Germany	Praxis Dr. med. M. Esser	Essen
Germany	Zentrum für klinische Forschung, Dr. med. Lüdemann	Falkensee
Germany	Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR	Hamburg
Germany	Diabetologische Schwerpunktpraxis Harburg - Dr. med.Paschen, Hamburg	Hamburg
Germany	Schulze	Jerichow
Germany	Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz	Lingen
Germany	Die Praxis am Ludwigsplatz	Ludwigshafen
Germany	Institut für Diabetesforschung GmbH Münster - Dr. med. Rose	Münster
Germany	RED-Institut für medizinische Forschung und Fortbildung GmbH	Oldenburg in Holstein
Germany	Praxis Dr. med. Wenzl-Bauer	Rehlingen-Siersburg
Germany	Vinzenz von Paul Kliniken GgmbH	Stuttgart
Germany	Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann	Witten
Hong Kong	Prince of Wales Hospital	Shatin, New Territories
India	Dr. Jivraj Mehta Health Foundation	Ahmedabad	Gujarat
India	HCG Hospitals	Ahmedabad	Gujarat
India	Lifecare Hospital and Research Centre	Bangalore	Karnataka
India	Ramaiah Memorial Hospital	Bangalore	Karnataka
India	Kanungo Institute of Diabetes Specialities Pvt Ltd	Bhubaneswar	Orissa
India	Madras Diabetes Research Foundation	Chennai	Tamil Nadu
India	Kg Hospital and Post Graduate Medical Institute	Coimbatore	Tamil Nadu
India	Apollo Excelcare Hospital	Guwahati	Assam
India	Apollo Excelcare Hospital, Guwahati	Guwahati	Assam
India	Care Outpatient Centre	Hyderabad	Andhra Pradesh
India	Gandhi Hospital & Medical college	Hyderabad	Telengana
India	Osmania General Hospital	Hyderabad	A.p.
India	Ramdev Rao Hospital	Hyderabad	Andhra Pradesh
India	Ramdev Rao Hospital	Hyderabad	Telangana
India	Sunshine Hospital	Hyderabad	Andhra Pradesh
India	TOTALL Diabetes Hormone Institute	Indore	Madhya Pradesh
India	Diabetes, Thyroid and Endocrine Centre	Jaipur	Rajasthan
India	Apollo Gleneagles Hospital	Kolkata	West Bengal
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	SSKM	Kolkata	West Bengal
India	Calicut Medical College	Kozhikode	Kerala
India	Christian Medical College and Hospital	Ludhiana	Punjab
India	Dayanand Medical College & Hospital	Ludhiana	Punjab
India	Fortis Heart Institute and Multispeciality Hospital	Mohali	Punjab
India	BSES MG hospital	Mumbai	Maharashtra
India	BYL Nair Hospital and T N Medical College Department of endo	Mumbai	Maharashtra
India	Fortis Hospital Mulund	Mumbai	Maharashtra
India	Fortis Hospital, Mulund, Mumbai	Mumbai	Maharashtra
India	P D Hinduja National Hospital and Medical Research Centre	Mumbai	Maharashtra
India	All India Institute of Medical Sciences	New Dehli	New Delhi
India	Lady Hardinge Medical College	New Delhi
India	North Delhi Diabetes Centre	New Delhi
India	chelleram Diabetes Institute	Pune	Maharashtra
India	Inamdar Multispeciality Hospital	Pune	Maharashtra
India	Christian Medical College Hospital, Vellore	Ranipet	Tamil Nadu
India	PGIMS Rohtak	Rohtak	Haryana
India	Jothydev's Diabetes & Research Center	Thriruvananthapuram
India	Christian Medical College Hospital, Vellore	Vellore	Tamil Nadu
Israel	Diabetes and obesity center of excellence, Rambam MC	Haifa
Israel	Diabetes Unit Hadassah Ein Karem MC	Jerusalem
Israel	Endocrinology & Diabetes Clinic Clalit Jerusalem	Jerusalem
Israel	Clinical Research Unit Meir Medical Center	Kfar Saba
Israel	Institute of Diabetes, Western Galilee MC Nahariya	Nahariya
Israel	Rabin MC Beilinson Campus Endo	Petah-Tikva
Israel	Endrocrinolgy Clinic - Sheba Medical Center	Tel Hashomer
Israel	Sheba Medica Center - Clinical Research Unit	Tel Hashomer
Israel	Institute of Endocrinology, metabolism and hypertension	Tel-Aviv
Italy	A.O.U. Consorziale Policlinico di Bari	Bari	BA
Italy	Azienda Ospedaliero-Universitaria Renato Dulbecco	Catanzaro	Cz
Italy	Università degli Studi G. D'Annunzio	Chieti
Italy	Ospedale Civile Campo di Marte	Lucca	LU
Italy	Centro Cardiologico Monzino. Istituto di Ricovero e Cura	Milano
Italy	Istituto Scientifico San Raffaele	Milano	MI
Italy	Università Federico II Dip. di Med. Clinica e Chirurgia Ed 1	Napoli
Italy	Azienda Ospedaliera di Padova Malatt.Metab	Padova
Italy	Dip. di Medicina Interna Policlinico Universitario Palermo	Palermo
Italy	Unità Funzionale di nutrizione clinica cod 58.01.3	Palermo
Italy	Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser	Perugia
Italy	Policlinico Umberto I Seconda Clinica Medica	Roma	RM
Italy	Policlinico Universitario Tor Vergata	Roma
Japan	The University of Tokyo Hospital, Diabetes and Metabolic	Bunkyo-ku, Tokyo
Japan	New Tokyo Heart Clinic_Matsudo-shi, Chiba,	Chiba
Japan	Ehime Prefectural Central Hospital	Ehime
Japan	Fukui Prefectural Hospital	Fukui
Japan	Fukuoka Tokushukai Hospital	Fukuoka
Japan	Naka Kinen Clinic	Ibaraki
Japan	Jinnouchi Hospital	Kumamoto-shi	Kumamoto, Japan
Japan	Uji Tokushukai Medical Center	Kyoto
Japan	Kyoto University Hospital	Kyoto-shi, Kyoto
Japan	Shinden Higashi Clinic_Miyagi	Miyagi
Japan	Heiwadai Hospital	Miyazaki-shi	Miyazaki
Japan	Shinshu University Hospital	Nagano
Japan	Nozaki Tokushukai Hospital	Osaka
Japan	Osaka University Hospital_Osaka	Osaka
Japan	Saiseikai Suita Hospital	Osaka
Japan	Takatsuki Red Cross Hospital	Osaka
Japan	Saga University Hospital, Department of Cardiology	Saga-shi, Saga
Japan	Hanaoka Seishu Memorial Hospital	Sapporo-shi, Hokkaido
Japan	Kagawa Prefectural Central Hospital, Cardiovascular Medicine	Takamatsu-shi, Kagawa
Japan	Oyama East Clinic	Tochigi
Japan	Tokorozawa Heart Center	Tokorozawa-shi, Saitama
Japan	Juntendo University Hospital	Tokyo
Japan	Juntendo University Hospital_Tokyo	Tokyo
Japan	Minamino Cardiovascular Hospital	Tokyo
Japan	Sugawara Clinic	Tokyo
Japan	Tokyo Nishi Tokushukai Hospital	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Korea, Republic of	Hanyang University GURI Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu	Kelantan
Malaysia	Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan	Kota Bharu	Kelantan
Malaysia	Sarawak Heart Centre	Kota Samarahan	Sarawak
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Hospital Putrajaya	Putrajaya	Wilayah Persekutuan Putrajaya
Malaysia	Hospital Miri	Sarawak
Malaysia	Hospital Tuanku Jaafar	Seremban
Malaysia	University Technology MARA (UiTM) - Puncak Alam	Sungai Buloh	Selangor
Mexico	Centro de Investigación Cardiometabólica de Aguascalientes	Aguascalientes
Mexico	Arechavaleta Granell María del Rosario	Guadalajara	Jalisco
Mexico	Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC	Guadalajara	Jalisco
Mexico	Investigación Médica Sonora S.C.	Hermosillo	Sonora
Mexico	Medical Care and Research S. A de C.V	Merida	Yucatan
Mexico	Centro de Desarrollo Biomédico S.C.P.	Mérida	Yucatan
Mexico	EME Red Hospitalaria	Mérida	Yucatán
Mexico	Cardiolink Clin Trials S.C.	Monterrey	Nuevo Leon
Mexico	Internal Medicine Clin Trials	Monterrey	Nuevo León
Mexico	Unidad Medica para la Salud Integral (UMSI)	San Nicolas de los Garza	Nuevo León
Mexico	Centro de Atención Integral al Paciente con Diabetes	Tlalpan	México, D.F.
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Amsterdam UMC Lokatie VUMC	Amsterdam
Netherlands	Gelre Ziekenhuizen Apeldoorn	Apeldoorn
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Máxima Medisch Centrum	Eindhoven
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Bethesda Diabetes Research Center en Bethesda ziekenhuis	Hoogeveen
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Radboudumc	Nijmegen
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Romania	CMI Dr. Pletea Noemi SRL	Bacau
Romania	Diabet Med SRL	Bucharest
Romania	Clinic of Diabetes Cluj	Cluj Napoca	Cluj
Romania	Clinical Emergency Sf. Apostol Andrei Hospital	Galati
Romania	Spitalul Clinic Judetean de Urgente Sf. Spiridon	Iasi
Romania	CMI Dr. Busegeanu Mihaela Magdalena	Ploiesti	Prahova
Romania	Novus Medical Clinica SRL	Ploiesti	Prahova
Romania	SC Gensan SRL, Policlinica ASTRA	Sibiu
Romania	Spitalul Judetean de Urgenta Targoviste	Targoviste	Dambovita
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures	Targu Mures	Mures
Romania	Sc Mediab Srl	Tirgu Mures	Mures
Russian Federation	City Hospital #5	Barnaul
Russian Federation	Kazan Federal University	Kazan
Russian Federation	LLC "Clinic of Aesthetic Medicine & Laser Technologies"	Kazan
Russian Federation	SAHI Kuzbass Hospital(former Regional clinical hospital)	Kemerovo
Russian Federation	Friendship University of Russia	Moscow
Russian Federation	Setchenov First Moscow State Medical University	Moscow
Russian Federation	Limited Law Company "Healthy Family" Medicine Center"	Novosibirsk
Russian Federation	State Novosibirsk regional clinical hospital	Novosibirsk
Russian Federation	Penza Regional Clinical Hospital named after N.N. Burdenko	Penza
Russian Federation	Aurora MedFort LLC	Saint Petersburg
Russian Federation	City Consultative & Diagnostic Centre #1	Saint-Petersburg
Russian Federation	Consultative & Diagnostic Center with a Outpatient Hospital	Saint-Petersburg
Russian Federation	SPb SBHI City Outpatient clinic #37	Saint-Petersburg
Russian Federation	Regional clinical cardiology dispensary	Saratov
Russian Federation	Saratov regional clinical hospital	Saratov
Russian Federation	SPb SBHI City Multifield Hospital #2	St. Petersburg
Russian Federation	Siberian State Medical University	Tomsk
Russian Federation	Tumen State Medical University	Tumen	Russia
Russian Federation	Ulianovsk Regional Clinical Hospital	Ulianovsk
Russian Federation	Yaroslavl Regional Hospital	Yaroslavl
Russian Federation	Polyclinic #2 in Yoshkar-Ola	Yoshkar-Ola
Serbia	CHC Zvezdara, Clinical department for endocrinology	Belgrade
Serbia	Endocrinology, Diabetes and Metabolism Diseases Clinic	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department	Kragujevac
Serbia	Clinical Centre Nis, Endocrinology, Diabetes and Metabolism	Nis
Serbia	Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.	Novi Sad	Vojvodina
Serbia	Policlinic for diabetes	Zajecar
Slovakia	Diabetologická ambulancia - Nemocnica akademika L. Derera, UNB	Bratislava
Slovakia	Diabetologicka ambulancia MediTask, s.r.o	Bratislava
Slovakia	Metabolicke Centrum MUDr. Katariny Raslovej s.r.o.	Bratislava
Slovakia	CARDIO D&R, s.r.o.	Kosice
Slovakia	HUMAN-CARE s.r.o.	Kosice
Slovakia	Nemocnica Krompachy spol. s r.o Diabetol. amb. MD Gmitrov	Krompachy
Slovakia	Diabetologicka ambulancia MUDr. Katarina Plevova, s.r.o.	Nitra
Slovakia	DENTAVIA s.r.o.	Poprad
Slovakia	MUDr. Jan Culak, s.r.o.	Prievidza
Slovakia	Kardiologicka a interna ambulancia	Rimavska Sobota
Slovakia	Tatratrial s.r.o.	Roznava
Slovakia	IRIDIA s.r.o.	Vrutky
South Africa	Diabetes Care Centre & CDE Centre	Benoni	Gauteng
South Africa	Dr H Bacus	Berea	KwaZulu-Natal
South Africa	Diabetes Clinical Trials Unit	Cape Town	Western Cape
South Africa	UCT Clinical Research Centre	Cape Town	Western Cape
South Africa	Dr A Amod	Durban	KwaZulu-Natal
South Africa	Dr Pillay's Rooms	Durban	KwaZulu-Natal
South Africa	Dr T Padayachee	Durban	KwaZulu-Natal
South Africa	Centre for Diabetes	Johannesburg	Gauteng
South Africa	Deepak Lakha	Johannesburg	Gauteng
South Africa	Deepak Lakha	Johannesburg	Gauteng
South Africa	Hemant Makan	Johannesburg	Gauteng
South Africa	Peermed Clinical Trial Centre	Johannesburg	Gauteng
South Africa	Soweto Clinical Trial Centre	Johannesburg	Gauteng
South Africa	Dr Seeber	Pretoria	Gauteng
South Africa	Prof P. Joshi	Pretoria	Gauteng
Spain	Hospital Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital Comarcal de Antequera	Antequera
Spain	Hospital del Mar	Barcelona
Spain	Hospital Público da Mariña	Burela
Spain	Hospital Reina Sofia	Córdoba
Spain	Complejo Hospitalario Universitario A Coruña	La Coruña
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas de Gran Canaria
Spain	Hospital Ribera Polusa	Lugo
Spain	Hospital Clínico Virgen de la Victoria	Málaga
Spain	Hospital Quirón	Pozuelo de Alarcon
Spain	Hospital Virgen del Camino - Sanlúcar de Barrameda	Sanlúcar de Barrameda
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela
Spain	Hospital Virgen de la Macarena	Sevilla
Taiwan	Changhua Christian Hospital	Changhua City
Taiwan	Chung Shan Medical University Hospital	Taichung City
Taiwan	Chang Gung Medical Foundation - Linkou Branch	Taoyuan city
Thailand	King Chulalongkorn Memorial Hospital_Bangkok	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Police General Hospital	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Ramathibodi Hospital-Cardiovascular metabolic Center	Bangkok
Thailand	Siriraj Hospital_Bangkok_1	Bangkok
Thailand	Siriraj Hospital_Bangkoknoi, Bangkok	Bangkoknoi, Bangkok	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai	Mueang Chiang Mai District
Thailand	Maharat Nakhon Ratchasima Hospital	Nakhon Ratchasima
Thailand	Songklanagarind Hospital	Songkla
Turkey	T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastan	Adana
Turkey	Gulhane Egitim Arastirma Hastanesi	Ankara
Turkey	T.C. Saglik Bakanligi Bursa Il Saglik Mudurlugu Yuksek Ihtis	Bursa
Turkey	Ataturk Universitesi Tip Fakultesi	Erzurum
Turkey	Eskisehir Osmangazi University School of Medicine	Eskisehir
Turkey	Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm	Hatay
Turkey	Haseki Egitim ve Arastirma Hastanesi_ISTANBUL	Istanbul
Turkey	Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi	Istanbul
Turkey	T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul
Turkey	Dokuz Eylul University Medical Faculty	Izmir
Turkey	Erciyes Universitesi Tip Fakultesi	Kayseri
Turkey	Sivas Cumhuriyet Univesity Endocrinology Department	Sivas
Turkey	Karadeniz University School of Medicine-Adult Endocrinology	Trabzon
Ukraine	Cherkasy Regional Hospital of Cherkasy Reg. Council	Cherkasy
Ukraine	RMI "Chernivtsi Regional Endocrinology Centre"	Chernivtsi
Ukraine	CI Dnipropetrovsk Regional Hospital	Dnipro
Ukraine	Clinical Hosp on the railway line ?2 branch PHC JSC Ukrzaliz	Kyiv
Ukraine	SRI "Centre of Innovative Medical Technologies of the NASU"	Kyiv
Ukraine	Lviv Regional Endocrinology Diagnostic and Treatment Centre	Lviv
Ukraine	Odesa Regional Clinical Hospital	Odesa
Ukraine	CI "1st City Clinical Hospital of Poltava City Council"	Poltava
Ukraine	Transcarpathian Regional Clinical Hospital of A. Novak	Uzhhorod
Ukraine	Zhytomir Regional Clinical Hospital	Zhytomyr
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Crouch Oak Family Practice	Addlestone	Surrey
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	The Health Centre	Bradford-on-Avon
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Addenbrooke's Hospital_Cambridge	Cambridge
United Kingdom	Hathaway Surgery	Chippenham
United Kingdom	WISDEM Centre	Coventry
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Glasgow Clinical Research Facility	Glasgow
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Harrogate District Hospital	Harrogate
United Kingdom	Burbage Surgery	Hinckley
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Royal Free - Diabetes	London
United Kingdom	Diabetes Centre North Manchester General Hospital	Manchester
United Kingdom	The Norfolk and Norwich University Hospital	Norfolk
United Kingdom	University Dept of Medicine, Derriford Hospital, Plymouth	Plymouth
United Kingdom	East Surrey Hospital	Redhill
United Kingdom	The Staploe Medical Centre	Soham
United Kingdom	Joint Clinical Research Facility - Swansea	Swansea
United States	Albany Medical College - Endo	Albany	New York
United States	Ellipsis Group	Alpharetta	Georgia
United States	Arlington Family Res. Ctr Inc	Arlington	Texas
United States	Mountain Diabetes & Endocrine Center	Asheville	North Carolina
United States	Rocky Mount Reg VA Med-DN	Aurora	Colorado
United States	Central Texas Clinical Research	Austin	Texas
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	Texas Diabetes & Endocrinology, P.A._Austin	Austin	Texas
United States	Heritage Valley Medical Group Inc	Beaver	Pennsylvania
United States	East Coast Medical Associates, Inc.	Boca Raton	Florida
United States	Northern Pines Hlth Ctr, PC	Buckley	Michigan
United States	Kernodle Clin Dpt-Pvt Diagnost	Burlington	North Carolina
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Michael L Reeves, MD	Chattanooga	Tennessee
United States	Univ Diab & Endo Consultants	Chattanooga	Tennessee
United States	UT Southwestern Med Cntr	Dallas	Texas
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Creekside Endocrine Associates, PC	Denver	Colorado
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Diabetes and Thyroid Ctr of FW	Fort Worth	Texas
United States	American Health Network of IN LLC_Franklin	Franklin	Indiana
United States	B&K Medical Research Center	Fresno	California
United States	New West Physicians,Inc.	Golden	Colorado
United States	American Health Network of Indiana, LLC_Greenfield	Greenfield	Indiana
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	Physicians East Endocrinology	Greenville	North Carolina
United States	Clinical Invest Special_Gurnee	Gurnee	Illinois
United States	East West Med Res Inst	Honolulu	Hawaii
United States	PrimeCare Medical Group	Houston	Texas
United States	Synergy Groups Medical	Houston	Texas
United States	Rocky Mountain Diab&Osteo Ctr	Idaho Falls	Idaho
United States	Clinical Inv Spec, Inc.Kenosha	Kenosha	Wisconsin
United States	Holston Medical Group	Kingsport	Tennessee
United States	Scripps Whittier Diabetes Inst	La Jolla	California
United States	Diabetes & Endocrine Associates	La Mesa	California
United States	First Valley Medical Group	Lancaster	California
United States	Palm Research Center Inc-Vegas	Las Vegas	Nevada
United States	Physicians Research Assoc. LLC	Lawrenceville	Georgia
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	The Research Group of Lexington LLC	Lexington	Kentucky
United States	Medical Investigations, Inc.	Little Rock	Arkansas
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	Pacific Clinical Studies	Los Alamitos	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Robley Rex VA Medical Center	Louisville	Kentucky
United States	Awasty Research Network	Marion	Ohio
United States	Advanced Med Res Maumee	Maumee	Ohio
United States	Primary Care Research South, Inc	McMurray	Pennsylvania
United States	Your Diabetes Endocrine Nutrition Group, Inc.	Mentor	Ohio
United States	Franciscan Health Michigan City	Michigan City	Indiana
United States	Midland Clinical Research Center	Midland	Texas
United States	Facey Medical Foundation	Mission Hills	California
United States	Monterey Endocrine & Diabetes Institute, Inc	Monterey	California
United States	Healthscan Clinical Trials,LLC.	Montgomery	Alabama
United States	American Health Network of IN LLC	Muncie	Indiana
United States	The Diabetes Center, LLC	Murrells Inlet	South Carolina
United States	Carolina Health Specialists	Myrtle Beach	South Carolina
United States	Southern New Hampshire Diabetes and Endocrinology	Nashua	New Hampshire
United States	InvestiClin Research	Nashville	Tennessee
United States	MidState Endocrine Associates	Nashville	Tennessee
United States	Vanderbilt Diab Obes Clin Tri	Nashville	Tennessee
United States	Eastern Nephr Assoc, PLLC	New Bern	North Carolina
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Suncoast Clinical Research, Inc._New Port Richey	New Port Richey	Florida
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Methodist Phys. Clinic	Omaha	Nebraska
United States	Univ of Nebraska Medical CTR	Omaha	Nebraska
United States	AdventHealth Diab Inst	Orlando	Florida
United States	Desert Oasis Hlthcr Med Group	Palm Springs	California
United States	Aria Endocrine Metabolic Assoc	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania
United States	Dominion Medical Associates	Richmond	Virginia
United States	Endo Res Solutions Inc	Roswell	Georgia
United States	Texas Diabetes & Endocrinology, P.A._Austin	Round Rock	Texas
United States	San Diego Family Care	San Diego	California
United States	Unity Health-Searcy Medical Center	Searcy	Arkansas
United States	Ileana J Tandron APMC	Slidell	Louisiana
United States	University of Vermont Medical Center	South Burlington	Vermont
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Simcare Medical Research, LLC	Sugar Land	Texas
United States	Lundquist Inst-Biomed Innovtn	Torrance	California
United States	Trinity Clinical Research LLC	Tullahoma	Tennessee
United States	Twinsburg Family Health Center	Twinsburg	Ohio
United States	Coastal Metabolic Research Center	Ventura	California
United States	Hillcrest Family Health Center	Waco	Texas
United States	Iowa Diab & Endo Res Center	West Des Moines	Iowa
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Great Lakes Medical Research	Westfield	New York
United States	Whiteville Medical Associates	Whiteville	North Carolina
United States	Accellacare	Wilmington	North Carolina
United States	Selma Medical Associates	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  China,  Colombia,  Croatia,  Czechia,  Denmark,  France,  Germany,  Hong Kong,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time 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	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven)
Secondary	Time to first occurrence of a composite endpoint	Time to first occurrence of a composite endpoint consisting of: CV death/renal death/onset of persistent 50% or more reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (compared with baseline)/onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2/initiation of chronic renal replacement therapy (dialysis or kidney transplantation).; Unit of assessment: Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to occurrence of CV death	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of an expanded MACE composite endpoint consisting of: CV death/non-fatal myocardial infarction/ non-fatal stroke/coronary revascularisation/unstable angina requiring hospitalisation	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of a composite heart failure endpoint consisting of: CV death/heart failure requiring hospitalisation/urgent heart failure visit	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of a composite CKD endpoint	Time to first occurrence of a composite CKD endpoint consisting of: renal death/onset of persistent 50% or more reduction in eGFR (CKD-EPI)/onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2/initiation of chronic renal replacement therapy (dialysis or kidney transplantation).; Unit of assessment: Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to occurrence of all-cause death	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of non-fatal myocardial infarction (MI)	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of non-fatal stroke	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of heart failure requiring hospitalisation	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of urgent heart failure visit	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of coronary revascularisation	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of unstable angina requiring hospitalisation	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to occurrence of renal death	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of onset of persistent 50% or more reduction in eGFR	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation)	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of a composite endpoint consisting of: all-cause death/non-fatal myocardial infarction/non-fatal stroke	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of acute limb ischemia	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of chronic limb ischemia	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Annual rate of change in eGFR (CKD-EPI) (total eGFR slope)	ml/min/1.73 m^2 per year	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Change in glycosylated haemoglobin (HbA1c)	Percent points	From randomisation (week 0) to 2 years
Secondary	Change in body weight	Kilograms	From randomisation (week 0) to 2 years
Secondary	Number of severe hypoglycaemic episodes	Number of events	From randomisation (week 0) to end-of-trial (up to 61 months or more)
Secondary	Time to first occurrence of a severe hypoglycaemic episode	Months	From randomisation (week 0) to end-of-trial (up to 61 months or more)