Diabetes Mellitus, Type 2 Clinical Trial
— SOULOfficial title:
Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
Verified date | June 2024 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
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,
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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