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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
First received
Last updated
Start date June 17, 2019
Est. completion date August 23, 2024

Study information

Verified date June 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
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 August 23, 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

Study Design


Related Conditions & MeSH terms


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 i9 Pesquisas Clínicas Campinas Sao Paulo
Brazil Instituto de Pesquisa Clínica de Campinas 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
Malaysia Hospital Putrajaya Wilayah Persekutuan Putrajaya
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 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 Clin Res Port Richey New Port Richey Florida
United States Lynn Institute of Norman Norman Oklahoma
United States Methodist Physicians Clinic Diabetes and Endocrinology Specialists 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)
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