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Clinical Trial Details

Trial ID: L3135
Source ID: NCT03914326
Associated Drug: Semaglutide
Title: A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes
Acronym: SOUL
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide|DRUG: Placebo (semaglutide)
Outcome Measures: 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)|Time to occurrence of CV death, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|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)|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)|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)|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)|Time to occurrence of all-cause death, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|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)|Time to first occurrence of non-fatal stroke, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|Time to first occurrence of heart failure requiring hospitalisation, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|Time to first occurrence of urgent heart failure visit, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|Time to first occurrence of coronary revascularisation, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|Time to first occurrence of unstable angina requiring hospitalisation, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|Time to occurrence of renal death, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|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)|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)|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)|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)|Time to first occurrence of acute limb ischemia, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|Time to first occurrence of chronic limb ischemia, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)|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)|Change in glycosylated haemoglobin (HbA1c), Percent points, From randomisation (week 0) to 2 years|Change in body weight, Kilograms, From randomisation (week 0) to 2 years|Number of severe hypoglycaemic episodes, Number of events, From randomisation (week 0) to end-of-trial (up to 61 months or more)|Time to first occurrence of a severe hypoglycaemic episode, Months, From randomisation (week 0) to end-of-trial (up to 61 months or more)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 9651
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-06-17
Completion Date: 2024-08-23
Results First Posted:
Last Update Posted: 2025-04-09
Locations: Healthscan Clinical Trials,LLC., Montgomery, Alabama, 36106, United States|Medical Investigations, Inc., Little Rock, Arkansas, 72211, United States|Unity Health-Searcy Medical Center, Searcy, Arkansas, 72143, United States|B&K Medical Research Center, Fresno, California, 93721-1443, United States|Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States|Diabetes & Endocrine Associates, La Mesa, California, 91942, United States|First Valley Medical Group, Lancaster, California, 93534, United States|Pacific Clinical Studies, Los Alamitos, California, 90720, United States|Facey Medical Foundation, Mission Hills, California, 91345, United States|Monterey Endocrine & Diabetes Institute, Inc, Monterey, California, 93940, United States|Desert Oasis Hlthcr Med Group, Palm Springs, California, 92262, United States|San Diego Family Care, San Diego, California, 92111, United States|Lundquist Inst-Biomed Innovtn, Torrance, California, 90502, United States|Coastal Metabolic Research Center, Ventura, California, 93003, United States|Rocky Mount Reg VA Med-DN, Aurora, Colorado, 80045, United States|Creekside Endocrine Associates, PC, Denver, Colorado, 80246, United States|New West Physicians,Inc., Golden, Colorado, 80401, United States|East Coast Medical Associates, Inc., Boca Raton, Florida, 33433, United States|Suncoast Clin Res Port Richey, New Port Richey, Florida, 34652, United States|AdventHealth Diab Inst, Orlando, Florida, 32804, United States|Ellipsis Group, Alpharetta, Georgia, 30022, United States|Physicians Research Assoc. LLC, Lawrenceville, Georgia, 30046, United States|Endo Res Solutions Inc, Roswell, Georgia, 30076, United States|East West Med Res Inst, Honolulu, Hawaii, 96814, United States|Rocky Mountain Diab&Osteo Ctr, Idaho Falls, Idaho, 83404-7596, United States|Clinical Invest Special_Gurnee, Gurnee, Illinois, 60031, United States|American Health Network of IN LLC_Franklin, Franklin, Indiana, 46131, United States|American Health Network of Indiana, LLC_Greenfield, Greenfield, Indiana, 46140, United States|Franciscan Health Michigan City, Michigan City, Indiana, 46360, United States|American Health Network of IN LLC, Muncie, Indiana, 47304, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50266, United States|The Research Group of Lexington LLC, Lexington, Kentucky, 40503, United States|Robley Rex VA Medical Center, Louisville, Kentucky, 40206, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, 70112, United States|Ileana J Tandron APMC, Slidell, Louisiana, 70461-4231, United States|Northern Pines Hlth Ctr, PC, Buckley, Michigan, 49620, United States|Methodist Phys. Clinic, Omaha, Nebraska, 68114, United States|Univ of Nebraska Medical CTR, Omaha, Nebraska, 68198-3020, United States|Palm Research Center Inc-Vegas, Las Vegas, Nevada, 89128, United States|Dartmouth-Hitchcock Med Ctr, Lebanon, New Hampshire, 03766, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03060, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Great Lakes Medical Research, Westfield, New York, 14787, United States|Mountain Diabetes & Endocrine Center, Asheville, North Carolina, 28803, United States|Kernodle Clin Dpt-Pvt Diagnost, Burlington, North Carolina, 27215, United States|University of North Carolina, Chapel Hill, North Carolina, 27514, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Physicians East Endocrinology, Greenville, North Carolina, 27834, United States|Eastern Nephr Assoc, PLLC, New Bern, North Carolina, 28562, United States|Whiteville Medical Associates, Whiteville, North Carolina, 28472, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Advanced Med Res Maumee, Maumee, Ohio, 43537, United States|Your Diabetes Endocrine Nutrition Group, Inc., Mentor, Ohio, 44060, United States|Twinsburg Family Health Center, Twinsburg, Ohio, 44087, United States|Lynn Institute of Norman, Norman, Oklahoma, 73072, United States|Heritage Valley Medical Group Inc, Beaver, Pennsylvania, 15009, United States|Primary Care Research South, Inc, McMurray, Pennsylvania, 15317, United States|Aria Endocrine Metabolic Assoc, Philadelphia, Pennsylvania, 19114, United States|Preferred Primary Care Physicians Inc., Pittsburgh, Pennsylvania, 15243, United States|The Diabetes Center, LLC, Murrells Inlet, South Carolina, 29576, United States|Carolina Health Specialists, Myrtle Beach, South Carolina, 29572, United States|Spartanburg Medical Research, Spartanburg, South Carolina, 29303, United States|Michael L Reeves, MD, Chattanooga, Tennessee, 37404, United States|Univ Diab & Endo Consultants, Chattanooga, Tennessee, 37411, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|InvestiClin Research, Nashville, Tennessee, 37203, United States|MidState Endocrine Associates, Nashville, Tennessee, 37203, United States|Vanderbilt Diab Obes Clin Tri, Nashville, Tennessee, 37212, United States|Trinity Clinical Research LLC, Tullahoma, Tennessee, 37388, United States|Arlington Family Res. Ctr Inc, Arlington, Texas, 76012-4637, United States|Central Texas Clinical Research, Austin, Texas, 78705, United States|Texas Diabetes & Endocrinology, P.A._Austin, Austin, Texas, 78731, United States|Texas Diabetes & Endocrinology, Austin, Texas, 78749, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|Diabetes and Thyroid Ctr of FW, Fort Worth, Texas, 76132, United States|PrimeCare Medical Group, Houston, Texas, 77024, United States|Synergy Groups Medical, Houston, Texas, 77061, United States|DCOL Ctr for Clin Res, Longview, Texas, 75605, United States|Midland Clinical Research Center, Midland, Texas, 79707, United States|Texas Diabetes & Endocrinology, P.A._Austin, Round Rock, Texas, 78681, United States|Simcare Medical Research, LLC, Sugar Land, Texas, 77478, United States|Hillcrest Family Health Center, Waco, Texas, 76708, United States|University of Vermont Medical Center, South Burlington, Vermont, 05403, United States|Dominion Medical Associates, Richmond, Virginia, 23219, United States|Selma Medical Associates, Winchester, Virginia, 22601-3834, United States|Clinical Inv Spec, Inc.Kenosha, Kenosha, Wisconsin, 60031, United States|Internal medicine department, Algiers, 16000, Algeria|endocrino-diabetology department, Hospital IBN BADIS., Constantine, 25000, Algeria|Internal Medecine department CHU Ibn Badis, Constantine, 25000, Algeria|EHU 1st November 1954, Oran, 31000, Algeria|Internal Medicine departement CHU Oran, Oran, 31000, Algeria|Department of internal of medicine, CHU Setif, Setif, 19000, Algeria|Centro Médico CIMEL, Lanus Este, Buenos Aires, B1824KAJ, Argentina|DIM Clinica Privada, Buenos Aires, B1704ETD, Argentina|Centro Medico Lebensohn, Buenos Aires, B6000BHA, Argentina|Hospital Italiano, Buenos Aires, C1181ACH, Argentina|Centro de Investigaciones Metabólicas, Capital Federal, C1056ABI, Argentina|Centro Diabetologico Cordoba Dr. Waitman, Cordoba, 5000, Argentina|Centro médico privado Cemaic, Córdoba, 5008, Argentina|Instituto Médico DAMIC, Córdoba, X5003DCE, Argentina|Centro Médico Privado San Vicente Diabetes, Córdoba, X5006IKK, Argentina|Centro Médico CIMEL, Lanus Este, B1824KAJ, Argentina|Instituto de Investigaciones Clinicas, Mar del Plata, B7600FZN, Argentina|Sanatorio Britanico S.A., Rosario, Santa Fe, S2000CVB, Argentina|Univ.-Klinik für Innere Medizin, Graz, 8036, Austria|Medizinische Universität Innsbruck, Innsbruck, 6020, Austria|Fließer-Görzer [Ordination], Saint Stefan, 8511, Austria|Klinik Hietzing, Wien, 1130, Austria|Klinik Ottakring, Wien, 1160, Austria|Imeldaziekenhuis - Bonheiden - Department of Endocrinology, Bonheiden, 2820, Belgium|UZ Antwerpen - UZA - Department of Endocrinology, Edegem, 2650, Belgium|UZA - UZ Antwerpen - Department of Endocrinology, Edegem, 2650, Belgium|UZ Gent - Endocrinologie - Diabetologie, Gent, 9000, Belgium|AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie, Kortrijk, 8500, Belgium|UZ Leuven - Endocrinology, Leuven, 3000, Belgium|AZ Delta - Roeselare - Diabeteskliniek, Roeselare, 8800, Belgium|AZ Delta - Roeselare, Roeselare, 8800, Belgium|Hospital do Coração do Brasil, Brasilia, Distrito Federal, 70390-700, Brazil|Cline Research Center, Curitiba, Parana, 80030-480, Brazil|Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV, Curitiba, Parana, 80045-110, Brazil|Hospital São Vicente de Paulo, Passo Fundo, Rio Grande Do Sul, 99010-080, Brazil|Instituto de Pesquisa Clínica de Campinas, Campinas, Sao Paulo, 13060-080, Brazil|i9 Pesquisas Clínicas, Campinas, Sao Paulo, 13092-133, Brazil|Instituto de Pesquisa Clinica (IPEC), São Paulo, Sao Paulo, 01223-001, Brazil|CPQuali Pesquisa Clínica Ltda, São Paulo, Sao Paulo, 01228-000, Brazil|CPCLIN - Centro de Pesquisas Clínicas, São Paulo, Sao Paulo, 01228-200, Brazil|C-endo Diab Endo Clin Calgery, Calgary, Alberta, T2V 4J2, Canada|Vancouver General Hospital_Vancouver_0, Vancouver, British Columbia, V5Z 1M9, Canada|Nova Scotia Hlth Halifax, Halifax, Nova Scotia, B3H 1V7, Canada|LMC Diabetes & Endocrinology (Barrie), Barrie, Ontario, L4N 7L3, Canada|LMC ClinRsrh Inc.Brampton, Brampton, Ontario, L6S 0C6, Canada|Aggarwal and Assoc Ltd., Brampton, Ontario, L6T 0G1, Canada|LMC Clinical Res Thornhill, Concord, Ontario, L4K 4M2, Canada|Premier Clinical Trial Research Network (PCTRN), Hamilton, Ontario, L8M 1K7, Canada|McMaster University, Hamilton, Ontario, L8N 3Z5, Canada|Bluewater Clin Res Group, Inc., Sarnia, Ontario, N7T 4X3, Canada|Bluewater Clin Res Group,Inc, Sarnia, Ontario, N7T 4X3, Canada|St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada|UHN-Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada|Diabetes Heart Research Centre, Toronto, Ontario, M6G 1M2, Canada|Manna Research Mirabel, Mirabel, Quebec, J7J 2K8, Canada|Applied Med Inf Res, Montreal, Quebec, H4A 3T2, Canada|CHU de Quebec-Universite Laval, Quebec, G1V 4G2, Canada|Peking University People's Hospital-Endocrinology, Beijing, Beijing, 100044, China|Cangzhou People's Hospital-Endocrinology, Cangzhou, Hebei, 061000, China|Cangzhou People's Hospital, Cangzhou, Hebei, 061000, China|Changzhou No.2 People's Hospital, Yanghu Branch, Changzhou, Jiangsu, 213003, China|The Affiliated Hospital of Jiangsu University-Endocrinology, Zhenjiang, Jiangsu, 212001, China|The Affiliated Hospital of Jiangsu University_Zhenjiang, Zhenjiang, Jiangsu, 212001, China|Jinan Central Hospital, Ji'nan, Shandong, 250013, China|Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, 250013, China|Shanghai Fifth People's Hospital-Endocrinology, Shanghai, Shanghai, 200240, China|Clinica de la Costa, Barranquilla, Atlántico, 80020, Colombia|Fundación Hospital Universidad del Norte, Soledad, Barranquilla, 83001, Colombia|Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia, Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander, 681012, Colombia|Fundacion Valle del Lili, Cali, Valle Del Cauca, 760032, Colombia|Clinica de la Costa, Barranquilla, 80020, Colombia|Fundación Centro de Obesidad y Metabolismo COMETA, Pasto, 520002, Colombia|Poliklinika Solmed, Zagreb, Grad Zagreb, 10000, Croatia|Specijalna bolnica Krapinske Toplice - Endokrinologija, Krapinske Toplice, 49217, Croatia|Klinicki bolnicki centar Osijek, Osijek, 31 000, Croatia|Opca bolnica Pula, Pula, 52100, Croatia|KBC Rijeka, Zavod za endokrinologiju, Rijeka, 51000, Croatia|KBC Split / Krizine / Dijabetes, Split, 21 000, Croatia|Opca bolnica Varazdin, Varazdin, 42 000, Croatia|Opca bolnica Zadar, Zadar, 23000, Croatia|KB Merkur - Sveucilisna klinika Vuk Vrhovac, Zagreb, 10 000, Croatia|KB Dubrava, Zavod za endokrinologiju i dijabetes, Zagreb, 10000, Croatia|University Hospital U sv. Anny, Brno, 602 00, Czechia|Intendia klinika, Chrudim, 53701, Czechia|FN Hradec Kralove, Hradec Kralove, 500 05, Czechia|Diabetologicka a Interni Ambulance MUDr. Jan Vrkoc s.r.o., Moravska Ostrava, 70200, Czechia|Ambulance DIA - INTERNA s.r.o., Ostrava, 73000, Czechia|Diabetologicka ambulance Plzen, Plzen, 30100, Czechia|MUDr. Jitka Zemanova diabetologie a interna, Plzeň - Východní Předměstí, 32600, Czechia|DIALINE s.r.o., Plzeň 3, 301 00, Czechia|Institut klinicke a experimentalni mediciny_Praha, Praha, 14021, Czechia|Aarhus Universitetshospital, Steno Diabetes Center Aarhus, Aarhus N, 8200, Denmark|Hillerød Endokrinologisk amb. H0652, Hillerød, 3400, Denmark|Bispebjerg Hospital, IC-Forskning, København, 2400, Denmark|Slagelse Sygehus Ambulatorium for hjertesygdomme, Slagelse, 4200, Denmark|Svendborg Sygehus, Svendborg, 5700, Denmark|Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz, Besançon cedex, 25030, France|Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage, DIJON cedex, 21079, France|Les Hopitaux de Chartres-Hopital Louis Pasteur, Le Coudray, 28630, France|Assistance Publique Hopitaux de Marseille-Hopital de La Conception, Marseille, 13005, France|Centre Hospitalier de Narbonne, Narbonne, 11100, France|Ap-Hp-Hopital Bichat-Claude Bernard-1, Paris, 75877, France|Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2, Pessac, 33600, France|Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-1, Strasbourg, 67098, France|MVZ "Am Felsenkeller" (Dresden), Dresden, 01277, Germany|Uniklinik TU Dresden Med. Klinik III, Dresden, 01307, Germany|Praxis Dr. med. M. Esser, Essen, 45219, Germany|Zentrum für klinische Forschung, Dr. med. Lüdemann, Falkensee, 14612, Germany|Diabetologische Schwerpunktpraxis Harburg - Dr. med.Paschen, Hamburg, Hamburg, 21073, Germany|Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR, Hamburg, 22041, Germany|Praxisgemeinschaft Jerichow, Jerichow, 39319, Germany|Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz, Lingen, 49808, Germany|Die Praxis am Ludwigsplatz, Ludwigshafen, 67059, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein, 23758, Germany|Praxis Dr. med. Wenzl-Bauer, Rehlingen-Siersburg, 66780, Germany|Marienhospital Stuttgart - Innere Medizin 1, Stuttgart, 70199, Germany|Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann, Witten, 58455, Germany|Prince of Wales Hospital, Shatin, New Territories, Hong Kong|Osmania General Hospital, Hyderabad, A.p., 500 012, India|Sunshine Hospital, Hyderabad, Andhra Pradesh, 500016, India|Care Outpatient Centre, Hyderabad, Andhra Pradesh, 500034, India|Ramdev Rao Hospital, Hyderabad, Andhra Pradesh, 500072, India|Apollo Excelcare Hospital, Guwahati, Guwahati, Assam, 781033, India|Apollo Excelcare Hospital, Guwahati, Assam, 781033, India|HCG Hospitals, Ahmedabad, Gujarat, 380006, India|Dr. Jivraj Mehta Health Foundation, Ahmedabad, Gujarat, 380007, India|PGIMS Rohtak, Rohtak, Haryana, 124001, India|Ramaiah Memorial Hospital, Bangalore, Karnataka, 560054, India|Lifecare Hospital and Research Centre, Bangalore, Karnataka, 560092, India|Calicut Medical College, Kozhikode, Kerala, 673008, India|TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, 452010, India|P D Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, 4000016, India|BYL Nair Hospital and T N Medical College Department of endo, Mumbai, Maharashtra, 400008, India|P D Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, 400016, India|BSES MG hospital, Mumbai, Maharashtra, 400058, India|Fortis Hospital Mulund, Mumbai, Maharashtra, 400078, India|Fortis Hospital, Mulund, Mumbai, Mumbai, Maharashtra, 400078, India|chelleram Diabetes Institute, Pune, Maharashtra, 411021, India|Inamdar Multispeciality Hospital, Pune, Maharashtra, 411040, India|All India Institute of Medical Sciences, New Dehli, New Delhi, 110029, India|Kanungo Institute of Diabetes Specialities Pvt Ltd, Bhubaneswar, Orissa, 751019, India|Dayanand Medical College & Hospital, Ludhiana, Punjab, 141001, India|Christian Medical College and Hospital, Ludhiana, Punjab, 141008, India|Fortis Heart Institute and Multispeciality Hospital, Mohali, Punjab, 160062, India|Diabetes, Thyroid and Endocrine Centre, Jaipur, Rajasthan, 302006, India|Madras Diabetes Research Foundation, Chennai, Tamil Nadu, 600086, India|Kg Hospital and Post Graduate Medical Institute, Coimbatore, Tamil Nadu, 641018, India|Christian Medical College Hospital, Vellore, Ranipet, Tamil Nadu, 632517, India|Christian Medical College Hospital, Vellore, Vellore, Tamil Nadu, 632004, India|Osmania General Hospital, Hyderabad, Telangana, 500012, India|Ramdev Rao Hospital, Hyderabad, Telangana, 500072, India|Gandhi Hospital & Medical college, Hyderabad, Telengana, 500003, India|SSKM, Kolkata, West Bengal, 700020, India|Apollo Gleneagles Hospital, Kolkata, West Bengal, 700054, India|Apollo Multispeciality Hospital, Kolkata, Kolkata, West Bengal, 700054, India|Lady Hardinge Medical College, New Delhi, 110001, India|Jothydev's Diabetes & Research Center, Thriruvananthapuram, 695 032, India|Diabetes and obesity center of excellence, Rambam MC, Haifa, 31096, Israel|Diabetes Unit Hadassah Ein Karem MC, Jerusalem, 91120, Israel|Endocrinology & Diabetes Clinic Clalit Jerusalem, Jerusalem, 93106, Israel|Clinical Research Unit Meir Medical Center, Kfar Saba, 44281, Israel|Institute of Diabetes, Western Galilee MC Nahariya, Nahariya, 22100, Israel|Rabin MC Beilinson Campus Endo, Petah-Tikva, 49100, Israel|Endrocrinolgy Clinic - Sheba Medical Center, Tel Hashomer, 52621, Israel|Sheba Medica Center - Clinical Research Unit, Tel Hashomer, 5265601, Israel|Institute of Endocrinology, metabolism and hypertension, Tel-Aviv, 6423906, Israel|A.O.U. Consorziale Policlinico di Bari, Bari, BA, 70124, Italy|Azienda Ospedaliero-Universitaria Renato Dulbecco, Catanzaro, Cz, 88100, Italy|Ospedale Civile Campo di Marte, Lucca, LU, 55100, Italy|Istituto Scientifico San Raffaele, Milano, MI, 20132, Italy|Policlinico Umberto I Seconda Clinica Medica, Roma, RM, 00161, Italy|Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia, Perugia, Umbria, 06129, Italy|Università degli studi G. D'Annunzio Chieti Pescara - CAST, Chieti Scalo, 66100, Italy|Centro Cardiologico Monzino. Istituto di Ricovero e Cura, Milano, 20138, Italy|Università Federico II Dip. di Med. Clinica e Chirurgia Ed 1, Napoli, 80131, Italy|Azienda Ospedaliera di Padova Malatt.Metab, Padova, 35128, Italy|Dip. di Medicina Interna Policlinico Universitario Palermo, Palermo, 90127, Italy|Policlinico Universitario Paolo Giaccone, Palermo, 90127, Italy|Jinnouchi Hospital, Kumamoto-shi, Kumamoto, Japan, 862-0976, Japan|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|The University of Tokyo Hospital, Diabetes and Metabolic, Bunkyo-ku, Tokyo, 113-8655, Japan|New Tokyo Heart Clinic_Matsudo-shi, Chiba,, Chiba, 271-0077, Japan|Ehime Prefectural Central Hospital, Ehime, 790-0024, Japan|Fukui Prefectural Hospital, Fukui, 910-0846, Japan|Fukuoka Tokushukai Hospital, Fukuoka, 816-0864, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Kyoto University Hospital, Kyoto-shi, Kyoto, 606-8507, Japan|Uji Tokushukai Medical Center, Kyoto, 611-0041, Japan|Shinden Higashi Clinic_Miyagi, Miyagi, 983-0039, Japan|Shinshu University Hospital, Nagano, 390-8621, Japan|Saiseikai Suita Hospital, Osaka, 564-0013, Japan|Osaka University Hospital_Osaka, Osaka, 565-0871, Japan|Takatsuki Red Cross Hospital, Osaka, 569-1045, Japan|Nozaki Tokushukai Hospital, Osaka, 574-0074, Japan|Saga University Hospital, Department of Cardiology, Saga-shi, Saga, 849-8501, Japan|Hanaoka Seishu Memorial Hospital, Sapporo-shi, Hokkaido, 062-0003, Japan|Kagawa Prefectural Central Hospital, Cardiovascular Medicine, Takamatsu-shi, Kagawa, 760-8557, Japan|Oyama East Clinic, Tochigi, 323-0022, Japan|Tokorozawa Heart Center, Tokorozawa-shi, Saitama, 356-1142, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Juntendo University Hospital_Tokyo, Tokyo, 113-8431, Japan|Juntendo University Hospital, Tokyo, 113-8431, Japan|Sugawara Clinic, Tokyo, 177-0041, Japan|Minamino Cardiovascular Hospital, Tokyo, 192-0918, Japan|Tokyo Nishi Tokushukai Hospital, Tokyo, 196-0003, Japan|Seoul National University Bundang Hospital, Gyeonggi-do, 13620, Korea, Republic of|Hanyang University GURI Hospital, Gyeonggi-do, 471-101, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, 03722, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of|Seoul Saint Mary's Hospital, Seoul, 06591, Korea, Republic of|Nowon Eulji Medical Center, Eulji University, Seoul, 139-827, Korea, Republic of|Hospital Sultanah Bahiyah, Alor Setar, Kedah, 05460, Malaysia|Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, 15586, Malaysia|Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan, Kota Bharu, Kelantan, 16150, Malaysia|Sarawak Heart Centre, Kota Samarahan, Sarawak, 94300, Malaysia|University Technology MARA (UiTM) - Puncak Alam, Sungai Buloh, Selangor, 47000, Malaysia|University Technology MARA (UiTM) - Sg Buloh, Sungai Buloh, Selangor, 47000, Malaysia|University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia|Hospital Putrajaya, Putrajaya, Wilayah Persekutuan Putrajaya, 62250, Malaysia|Hospital Sultanah Bahiyah, Alor Setar, 05460, Malaysia|Sarawak General Hospital, Kuching, 93586, Malaysia|Hospital Miri, Sarawak, 98000, Malaysia|Hospital Tuanku Jaafar, Seremban, 70300, Malaysia|Hospital Putrajaya, Wilayah Persekutuan Putrajaya, 62250, Malaysia|Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC, Guadalajara, Jalisco, 44600, Mexico|Arechavaleta Granell María del Rosario, Guadalajara, Jalisco, 44650, Mexico|Centro de Atención Integral al Paciente con Diabetes, Tlalpan, México, D.F., 14080, Mexico|Cardiolink Clin Trials S.C., Monterrey, Nuevo Leon, 64060, Mexico|Internal Medicine Clin Trials, Monterrey, Nuevo León, 64020, Mexico|Unidad Medica para la Salud Integral (UMSI), San Nicolas de los Garza, Nuevo León, 66465, Mexico|Investigación Médica Sonora S.C., Hermosillo, Sonora, 83280, Mexico|Medical Care and Research S. A de C.V, Merida, Yucatan, 97070, Mexico|Centro de Desarrollo Biomédico S.C.P., Mérida, Yucatan, 97070, Mexico|EME Red Hospitalaria, Mérida, Yucatán, 97000, Mexico|Centro de Investigación Cardiometabólica de Aguascalientes, Aguascalientes, 20230, Mexico|Meander Medisch Centrum, Amersfoort, 3813 TZ, Netherlands|Amsterdam UMC Lokatie VUMC, Amsterdam, 1081 HV, Netherlands|Gelre Ziekenhuizen Apeldoorn, Apeldoorn, 7334 DZ, Netherlands|Reinier de Graaf Gasthuis, Delft, 2625 AD, Netherlands|Maxima Medisch Centrum, Eindhoven, 5631 BM, Netherlands|Martini Ziekenhuis, Groningen, 9728 NT, Netherlands|Bethesda Diabetes Research Center en Bethesda ziekenhuis, Hoogeveen, 7909 AA, Netherlands|Maastricht Universitair Medisch Centrum, Maastricht, 6229 HX, Netherlands|Radboudumc, Nijmegen, 6525 GA, Netherlands|Universitair Medisch Centrum Utrecht, Utrecht, 3584 CX, Netherlands|Clinic of Diabetes Cluj, Cluj Napoca, Cluj, 400006, Romania|Spitalul Judetean de Urgenta Targoviste, Targoviste, Dambovita, 130083, Romania|Spitalul Clinic Judetean de Urgenta Targu Mures, Targu Mures, Mures, 540136, Romania|Sc Mediab Srl, Tirgu Mures, Mures, 540142, Romania|Novus Medical Clinica SRL, Ploiesti, Prahova, 100018, Romania|CMI Dr. Busegeanu Mihaela Magdalena, Ploiesti, Prahova, 100342, Romania|CMI Dr. Pletea Noemi SRL, Bacau, 600154, Romania|Diabet Med SRL, Bucharest, 051811, Romania|Clinical Emergency Sf. Apostol Andrei Hospital, Galati, 800578, Romania|SC Gensan SRL, Policlinica ASTRA, Sibiu, 550371, Romania|Tumen State Medical University, Tumen, Russia, 625023, Russian Federation|City Hospital #5, Barnaul, 656045, Russian Federation|Kazan Federal University, Kazan, 420012, Russian Federation|LLC "Clinic of Aesthetic Medicine & Laser Technologies", Kazan, 420111, Russian Federation|SAHI Kuzbass Hospital(former Regional clinical hospital), Kemerovo, 650066, Russian Federation|Friendship University of Russia, Moscow, 117292, Russian Federation|Setchenov First Moscow State Medical University, Moscow, 119435, Russian Federation|State Novosibirsk regional clinical hospital, Novosibirsk, 630087, Russian Federation|Limited Law Company "Healthy Family" Medicine Center", Novosibirsk, 630099, Russian Federation|Penza Regional Clinical Hospital named after N.N. Burdenko, Penza, 440052, Russian Federation|Aurora MedFort LLC, Saint Petersburg, 194156, Russian Federation|SPb SBHI City Outpatient clinic #37, Saint-Petersburg, 191119, Russian Federation|City Consultative & Diagnostic Centre #1, Saint-Petersburg, 194354, Russian Federation|Consultative & Diagnostic Center with a Outpatient Hospital, Saint-Petersburg, 197110, Russian Federation|Regional clinical cardiology dispensary, Saratov, 410039, Russian Federation|Saratov regional clinical hospital, Saratov, 410053, Russian Federation|SPb SBHI City Multifield Hospital #2, St. Petersburg, 194354, Russian Federation|Siberian State Medical University, Tomsk, 634050, Russian Federation|Ulianovsk Regional Clinical Hospital, Ulianovsk, 432063, Russian Federation|Yaroslavl Regional Hospital, Yaroslavl, 150062, Russian Federation|Polyclinic #2 in Yoshkar-Ola, Yoshkar-Ola, 424004, Russian Federation|Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis., Novi Sad, Vojvodina, 21000, Serbia|CHC Zvezdara, Clinical department for endocrinology, Belgrade, 11000, Serbia|Endocrinology, Diabetes and Metabolism Diseases Clinic, Belgrade, 11000, Serbia|Military Medical Academy, Belgrade, 11000, Serbia|Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department, Kragujevac, 34000, Serbia|Clinical Centre Nis, Endocrinology, Diabetes and Metabolism, Nis, 18000, Serbia|Policlinic for diabetes, Zajecar, 19000, Serbia|Metabolicke Centrum MUDr. Katariny Raslovej s.r.o., Bratislava, 831 01, Slovakia|MediTask, s.r.o, Bratislava, 83103, Slovakia|Nemocnica akademika L. Derera, UNB, Bratislava, 833 05, Slovakia|HUMAN-CARE s.r.o., Kosice, 040 01, Slovakia|CARDIO D&R, s.r.o., Kosice, 040 22, Slovakia|Nemocnica Krompachy spol. s r.o Diabetol. amb. MD Gmitrov, Krompachy, 05342, Slovakia|Diabetologicka ambulancia MUDr. Katarina Plevova, s.r.o., Nitra, 949 01, Slovakia|DENTAVIA s.r.o., Poprad, 05801, Slovakia|MUDr. Jan Culak, s.r.o., Prievidza, 97101, Slovakia|Kardiologicka a interna ambulancia, Rimavska Sobota, 97901, Slovakia|Tatratrial s.r.o., Roznava, 04801, Slovakia|IRIDIA s.r.o., Vrutky, 038 61, Slovakia|Diabetes Care Centre & CDE Centre, Benoni, Gauteng, 1501, South Africa|Peermed Clinical Trial Centre, Johannesburg, Gauteng, 1619, South Africa|Soweto Clinical Trial Centre, Johannesburg, Gauteng, 1818, South Africa|Deepak Lakha, Johannesburg, Gauteng, 1820, South Africa|Hemant Makan, Johannesburg, Gauteng, 1827, South Africa|Deepak Lakha, Johannesburg, Gauteng, 1829, South Africa|Centre for Diabetes, Johannesburg, Gauteng, 2198, South Africa|Dr Seeber, Pretoria, Gauteng, 0083, South Africa|Prof P. Joshi, Pretoria, Gauteng, 0181, South Africa|Dr H Bacus, Berea, KwaZulu-Natal, 4091, South Africa|Dr A Amod, Durban, KwaZulu-Natal, 4092, South Africa|Dr T Padayachee, Durban, KwaZulu-Natal, 4170, South Africa|Dr Pillay's Rooms, Durban, KwaZulu-Natal, 4450, South Africa|Diabetes Clinical Trials Unit, Cape Town, Western Cape, 7925, South Africa|UCT Clinical Research Centre, Cape Town, Western Cape, 7925, South Africa|Hospital Fundación Alcorcón, Alcorcón, Madrid, 28922, Spain|Hospital Comarcal de Antequera, Antequera, 29200, Spain|Hospital del Mar, Barcelona, 08003, Spain|Hospital Público da Mariña, Burela, 27880, Spain|Hospital Reina Sofia, Córdoba, 14004, Spain|Complejo Hospitalario Universitario A Coruña, La Coruña, 15006, Spain|Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, 35010, Spain|Hospital Ribera Polusa, Lugo, 27004, Spain|Hospital Clínico Virgen de la Victoria, Málaga, 29006, Spain|Hospital Quirón, Pozuelo de Alarcon, 28223, Spain|Hospital Virgen del Camino - Sanlúcar de Barrameda, Sanlúcar de Barrameda, 11540, Spain|Hospital Universitario Marqués de Valdecilla, Santander, 39008, Spain|Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, 15706, Spain|Hospital Virgen de la Macarena, Sevilla, 41009, Spain|Changhua Christian Hospital, Changhua City, 500, Taiwan|Chung Shan Medical University Hospital, Taichung City, 402, Taiwan|Chang Gung Medical Foundation - Linkou Branch, Taoyuan city, 333, Taiwan|Siriraj Hospital_Bangkoknoi, Bangkok, Bangkoknoi, Bangkok, Bangkok, 10700, Thailand|Songklanagarind Hospital, Songkla, Had-Yai, 90110, Thailand|Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Mueang Chiang Mai, 50200, Thailand|King Chulalongkorn Memorial Hospital_Bangkok, Bangkok, 10330, Thailand|Police General Hospital, Bangkok, 10330, Thailand|Phramongkutklao Hospital, Bangkok, 10400, Thailand|Rajavithi Hospital, Bangkok, 10400, Thailand|Ramathibodi Hospital-Cardiovascular metabolic Center, Bangkok, 10400, Thailand|Siriraj Hospital_Bangkok_1, Bangkok, 10700, Thailand|Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, 30000, Thailand|T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan, Adana, 01000, Turkey|Gulhane Egitim Arastirma Hastanesi, Ankara, 06010, Turkey|Bursa Il Saglik Mudurlugu Yuksek Ihtısas Egitim ve Arastirma Hastanesi, Bursa, 16310, Turkey|T.C. Saglik Bakanligi Bursa Il Saglik Mudurlugu Yuksek Ihtıs, Bursa, 16310, Turkey|Ataturk Universitesi Tip Fakultesi, Erzurum, 25240, Turkey|Eskisehir Osmangazi University School of Medicine, Eskisehir, 26040, Turkey|Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm, Hatay, 31060, Turkey|Haseki Egitim ve Arastirma Hastanesi_ISTANBUL, Istanbul, 34096, Turkey|Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi, Istanbul, 34303, Turkey|T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, 34722, Turkey|Dokuz Eylul University Medical Faculty, Izmir, 35340, Turkey|Erciyes Universitesi Tip Fakultesi, Kayseri, 38039, Turkey|Sivas Cumhuriyet Univesity Endocrinology Department, Sivas, 58140, Turkey|Karadeniz University School of Medicine-Adult Endocrinology, Trabzon, 61080, Turkey|Cherkasy Regional Hospital of Cherkasy Reg. Council, Cherkasy, 18009, Ukraine|RMI "Chernivtsi Regional Endocrinology Centre", Chernivtsi, 58022, Ukraine|CI Dnipropetrovsk Regional Hospital, Dnipro, 49005, Ukraine|Clinical Hosp on the railway line №2 branch PHC JSC Ukrzaliz, Kyiv, 03049, Ukraine|SRI "Centre of Innovative Medical Technologies of the NASU", Kyiv, 04053, Ukraine|Lviv Regional Endocrinology Diagnostic and Treatment Centre, Lviv, 79010, Ukraine|Odesa Regional Clinical Hospital, Odesa, 65025, Ukraine|CI "1st City Clinical Hospital of Poltava City Council", Poltava, 36039, Ukraine|Transcarpathian Regional Clinical Hospital of A. Novak, Uzhhorod, 88000, Ukraine|Zhytomir Regional Clinical Hospital, Zhytomyr, 10002, Ukraine|Crouch Oak Family Practice, Addlestone, Surrey, KT15 2BH, United Kingdom|Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, United Kingdom|Royal Victoria Hospital, Belfast, BT12 6BA, United Kingdom|The Health Centre, Bradford-on-Avon, BA15 1DQ, United Kingdom|Southmead Hospital, Bristol, BS10 5NB, United Kingdom|Addenbrooke's Hospital_Cambridge, Cambridge, CB2 0QQ, United Kingdom|Hathaway Surgery, Chippenham, SN15 1HP, United Kingdom|WISDEM Centre, Coventry, CV2 2DX, United Kingdom|Western General Hospital, Edinburgh, EH4 2XU, United Kingdom|Glasgow Clinical Research Facility, Glasgow, G31 2ER, United Kingdom|Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom|Harrogate District Hospital, Harrogate, HG2 7SX, United Kingdom|Burbage Surgery, Hinckley, LE10 2SE, United Kingdom|Hull Royal Infirmary, Hull, HU3 2JZ, United Kingdom|Royal Free - Diabetes, London, NW3 2QG, United Kingdom|North Manchester General Hospital - Diabetes Centre, Manchester, M8 5RB, United Kingdom|The Norfolk and Norwich University Hospital, Norfolk, NR4 7UQ, United Kingdom|University Dept of Medicine, Derriford Hospital, Plymouth, Plymouth, PL6 8DH, United Kingdom|East Surrey Hospital, Redhill, RH1 5RH, United Kingdom|The Staploe Medical Centre, Soham, CB7 5JD, United Kingdom|Joint Clinical Research Facility - Swansea, Swansea, SA2 8PP, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03914326