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

April 25, 2024 updated by: Novo Nordisk A/S

Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9642

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria, 16000
        • Internal medicine department
      • Constantine, Algeria, 25000
        • endocrino-diabetology department, Hospital IBN BADIS.
      • Constantine, Algeria, 25000
        • Internal Medecine department CHU Ibn Badis
      • Oran, Algeria, 31000
        • EHU 1st November 1954
      • Oran, Algeria, 31000
        • Internal Medicine departement CHU Oran
      • Setif, Algeria, 19000
        • Department of internal of medicine, CHU Setif
  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano
      • Buenos Aires, Argentina, B1704ETD
        • DIM Clínica Privada
      • Buenos Aires, Argentina, B6000BHA
        • Centro Medico Lebensohn
      • Capital Federal, Argentina, C1056ABJ
        • Centro de Investigaciones Metabólicas
      • Cordoba, Argentina, 5000
        • Centro Diabetologico Cordoba Dr. Waitman
      • Córdoba, Argentina, X5003DCE
        • Instituto Médico DAMIC
      • Córdoba, Argentina, X5006IKK
        • Centro Medico Privado San Vicente Diabetes
      • Córdoba, Argentina, 5008
        • Centro Medico Privado CEMAIC
      • Lanus Este, Argentina, B1824KAJ
        • Centro Médico CIMEL
      • Mar del Plata, Argentina, B7600FZN
        • Instituto de Investigaciones Clinicas
      • Rosario, Santa Fe, Argentina, S2000CVB
        • Sanatorio Britanico S.A.
  • Austria
      • Graz, Austria, 8036
        • Univ.-Klinik für Innere Medizin
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck
      • Saint Stefan, Austria, 8511
        • Fließer-Görzer [Ordination]
      • Wien, Austria, 1160
        • Klinik Ottakring
      • Wien, Austria, 1130
        • Klinik Hietzing
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis - Bonheiden - Department of Endocrinology
      • Edegem, Belgium, 2650
        • UZA - UZ Antwerpen - Department of Endocrinology
      • Edegem, Belgium, 2650
        • UZ Antwerpen - UZA - Department of Endocrinology
      • Gent, Belgium, 9000
        • UZ Gent - Endocrinologie - Diabetologie
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
      • Leuven, Belgium, 3000
        • UZ Leuven - Endocrinology
      • Roeselare, Belgium, 8800
        • AZ Delta - Roeselare - Diabeteskliniek
  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70390-700
        • Hospital do Coração do Brasil
    • Parana
      • Curitiba, Parana, Brazil, 80030-480
        • Cline Research Center
      • Curitiba, Parana, Brazil, 80045-170
        • Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
        • Hospital São Vicente de Paulo
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13060-080
        • Instituto de Pesquisa Clínica de Campinas
      • Campinas, Sao Paulo, Brazil, 13092-133
        • Loema Med e Bem Estar Centro Especializado em Cardiologia
      • São Paulo, Sao Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica Ltda
      • São Paulo, Sao Paulo, Brazil, 01228-200
        • CPCLIN - Centro de Pesquisas Clínicas
      • São Paulo, Sao Paulo, Brazil, 01223-001
        • Instituto de Pesquisa Clinica (IPEC)
  • Canada
      • Quebec, Canada, G1V 4G2
        • CHU de Quebec-Universite Laval
    • Alberta
      • Calgary, Alberta, Canada, T2V 4J2
        • C-endo Diab Endo Clin Calgery
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital_Vancouver_0
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Hlth Halifax
    • Ontario
      • Barrie, Ontario, Canada, L4N 7L3
        • LMC Diabetes & Endocrinology (Barrie)
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Assoc Ltd.
      • Brampton, Ontario, Canada, L6S 0C6
        • LMC ClinRsrh Inc.Brampton
      • Concord, Ontario, Canada, L4K 4M2
        • LMC (Thornhill)
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University
      • Hamilton, Ontario, Canada, L8M 1K7
        • Hamilton Med Res Group
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clin Res Group, Inc.
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clin Res Group,Inc
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M6G 1M2
        • Diabetes Heart Research Centre
      • Toronto, Ontario, Canada, M5G 2N2
        • UHN-Toronto General Hospital
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Manna Research Mirabel
      • Montreal, Quebec, Canada, H4A 3T2
        • Applied Med Inf Res
  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
    • Hebei
      • Cangzhou, Hebei, China, 061000
        • Cangzhou People's Hospital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Changzhou No.2 People's Hospital, Yanghu Branch
      • Zhenjiang, Jiangsu, China, 212001
        • The Affiliated Hospital of Jiangsu University_Zhenjiang
    • Shandong
      • Ji'nan, Shandong, China, 250013
        • Jinan Central Hospital
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital Affiliated to Shandong University
    • Shanghai
      • Shanghai, Shanghai, China, 200240
        • Shanghai Fifth People's Hospital
  • Colombia
      • Barranquilla, Colombia, 80020
        • Clinica de la Costa
      • Cali, Colombia, 760032
        • Fundacion Valle del Lili
      • Pasto, Colombia, 520002
        • Fundación Centro de Obesidad y Metabolismo COMETA
    • Barranquilla
      • Soledad, Barranquilla, Colombia, 83001
        • Fundación Hospital Universidad del Norte
    • Santander
      • Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander, Colombia, 681012
        • Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia
  • Croatia
      • Krapinske Toplice, Croatia, 49217
        • Specijalna bolnica Krapinske Toplice - Endokrinologija
      • Osijek, Croatia, 31 000
        • Klinicki bolnicki centar Osijek
      • Pula, Croatia, 52100
        • Opca bolnica Pula
      • Rijeka, Croatia, 51000
        • KBC Rijeka, Zavod za endokrinologiju
      • Split, Croatia, 21 000
        • KBC Split / Krizine / Dijabetes
      • Varazdin, Croatia, 42 000
        • Opca bolnica Varazdin
      • Zadar, Croatia, 23000
        • Opca bolnica Zadar
      • Zagreb, Croatia, 10 000
        • KB Merkur - Sveucilisna klinika Vuk Vrhovac
      • Zagreb, Croatia, 10000
        • KB Dubrava, Zavod za endokrinologiju i dijabetes
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed
  • Czechia
      • Brno, Czechia, 602 00
        • University Hospital U sv. Anny
      • Chrudim, Czechia, 53701
        • Intendia klinika
      • Hradec Kralove, Czechia, 500 05
        • FN Hradec Kralove
      • Moravska Ostrava, Czechia, 70200
        • Diabetologicka a Interni Ambulance MUDr. Jan Vrkoc s.r.o.
      • Ostrava, Czechia, 73000
        • Ambulance DIA - INTERNA s.r.o.
      • Plzen, Czechia, 30100
        • Diabetologicka ambulance Plzen
      • Plzeň - Východní Předměstí, Czechia, 32600
        • MUDr. Jitka Zemanova diabetologie a interna
      • Plzeň 3, Czechia, 301 00
        • DIALINE s.r.o.
      • Praha, Czechia, 14021
        • Institut klinicke a experimentalni mediciny_Praha
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital, Steno Diabetes Center Aarhus
      • Hillerød, Denmark, 3400
        • Hillerød Endokrinologisk amb. H0652
      • København, Denmark, 2400
        • Bispebjerg Hospital, IC-Forskning
      • Slagelse, Denmark, 4200
        • Slagelse Sygehus Ambulatorium for hjertesygdomme
      • Svendborg, Denmark, 5700
        • Svendborg Sygehus
  • France
      • Besançon cedex, France, 25030
        • Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz
      • DIJON cedex, France, 21079
        • Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
      • Le Coudray, France, 28630
        • Les Hopitaux de Chartres-Hopital Louis Pasteur
      • Marseille, France, 13005
        • Assistance Publique Hopitaux de Marseille-Hopital de La Conception
      • Narbonne, France, 11100
        • Centre Hospitalier de Narbonne
      • Paris, France, 75877
        • Ap-Hp-Hopital Bichat-Claude Bernard-1
      • Pessac, France, 33600
        • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
      • Strasbourg, France, 67098
        • Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-1
  • Germany
      • Dresden, Germany, 01277
        • Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
      • Dresden, Germany, 01307
        • Medizinische Klinik III Studienzentrum für Stoffwechselerkrankungen der TU Dresden
      • Essen, Germany, 45219
        • Praxis Dr. med. M. Esser
      • Falkensee, Germany, 14612
        • Zentrum für klinische Forschung, Dr. med. Lüdemann
      • Hamburg, Germany, 21073
        • Diabetologische Schwerpunktpraxis Harburg - Dr. med.Paschen, Hamburg
      • Hamburg, Germany, 22041
        • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
      • Jerichow, Germany, 39319
        • Schulze
      • Lingen, Germany, 49808
        • Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
      • Ludwigshafen, Germany, 67059
        • Die Praxis am Ludwigsplatz
      • Münster, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Oldenburg in Holstein, Germany, 23758
        • RED-Institut für medizinische Forschung und Fortbildung GmbH
      • Rehlingen-Siersburg, Germany, 66780
        • Praxis Dr. med. Wenzl-Bauer
      • Stuttgart, Germany, 70199
        • Vinzenz von Paul Kliniken GgmbH
      • Witten, Germany, 58455
        • Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Prince of Wales Hospital
  • India
      • New Delhi, India, 110001
        • Lady Hardinge Medical College
      • New Delhi, India, 110085
        • North Delhi Diabetes Centre
      • Thriruvananthapuram, India, 695 032
        • Jothydev's Diabetes & Research Center
    • A.p.
      • Hyderabad, A.p., India, 500 012
        • Osmania General Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500016
        • Sunshine Hospital
      • Hyderabad, Andhra Pradesh, India, 500034
        • Care Outpatient Centre
      • Hyderabad, Andhra Pradesh, India, 500072
        • Ramdev Rao Hospital
    • Assam
      • Guwahati, Assam, India, 781033
        • Apollo Excelcare Hospital, Guwahati
      • Guwahati, Assam, India, 781033
        • Apollo Excelcare Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • HCG Hospitals
      • Ahmedabad, Gujarat, India, 380007
        • Dr. Jivraj Mehta Health Foundation
    • Haryana
      • Rohtak, Haryana, India, 124001
        • PGIMS Rohtak
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Ramaiah Memorial Hospital
      • Bangalore, Karnataka, India, 560092
        • Lifecare Hospital and Research Centre
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Calicut Medical College
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Mumbai, Maharashtra, India, 400058
        • BSES MG hospital
      • Mumbai, Maharashtra, India, 400008
        • BYL Nair Hospital and T N Medical College Department of endo
      • Mumbai, Maharashtra, India, 4000016
        • P D Hinduja National Hospital and Medical Research Centre
      • Mumbai, Maharashtra, India, 400078
        • Fortis Hospital Mulund
      • Mumbai, Maharashtra, India, 400078
        • Fortis Hospital, Mulund, Mumbai
      • Pune, Maharashtra, India, 411040
        • Inamdar Multispeciality Hospital
      • Pune, Maharashtra, India, 411021
        • chelleram Diabetes Institute
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • All India Institute of Medical Sciences
    • Orissa
      • Bhubaneswar, Orissa, India, 751019
        • Kanungo Institute of Diabetes Specialities Pvt Ltd
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College and Hospital
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College & Hospital
      • Mohali, Punjab, India, 160062
        • Fortis Heart Institute and Multispeciality Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302006
        • Diabetes, Thyroid and Endocrine Centre
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Madras Diabetes Research Foundation
      • Coimbatore, Tamil Nadu, India, 641018
        • Kg Hospital and Post Graduate Medical Institute
      • Ranipet, Tamil Nadu, India, 632517
        • Christian Medical College Hospital, Vellore
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College Hospital, Vellore
    • Telangana
      • Hyderabad, Telangana, India, 500072
        • Ramdev Rao Hospital
    • Telengana
      • Hyderabad, Telengana, India, 500003
        • Gandhi Hospital & Medical college
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Apollo Gleneagles Hospital
      • Kolkata, West Bengal, India, 700054
        • Apollo Multispeciality Hospital, Kolkata
      • Kolkata, West Bengal, India, 700020
        • SSKM
  • Israel
      • Haifa, Israel, 31096
        • Diabetes and obesity center of excellence, Rambam MC
      • Jerusalem, Israel, 91120
        • Diabetes Unit Hadassah Ein Karem MC
      • Jerusalem, Israel, 93106
        • Endocrinology & Diabetes Clinic Clalit Jerusalem
      • Kfar Saba, Israel, 44281
        • Clinical Research Unit Meir Medical Center
      • Nahariya, Israel, 22100
        • Institute of Diabetes, Western Galilee MC Nahariya
      • Petah-Tikva, Israel, 49100
        • Rabin MC Beilinson Campus Endo
      • Tel Hashomer, Israel, 52621
        • Endrocrinolgy Clinic - Sheba Medical Center
      • Tel Hashomer, Israel, 5265601
        • Sheba Medica Center - Clinical Research Unit
      • Tel-Aviv, Israel, 64239
        • Institute of Endocrinology, metabolism and hypertension
  • Italy
      • Chieti, Italy, 66100
        • Università degli Studi G. D'Annunzio
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino. Istituto di Ricovero e Cura
      • Napoli, Italy, 80131
        • Università Federico II Dip. di Med. Clinica e Chirurgia Ed 1
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova Malatt.Metab
      • Palermo, Italy, 90127
        • Unità Funzionale di nutrizione clinica cod 58.01.3
      • Palermo, Italy, 90127
        • Dip. di Medicina Interna Policlinico Universitario Palermo
      • Perugia, Italy, 06129
        • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser
      • Roma, Italy, 00133
        • Policlinico Universitario Tor Vergata
    • BA
      • Bari, BA, Italy, 70124
        • A.O.U. Consorziale Policlinico di Bari
    • Cz
      • Catanzaro, Cz, Italy, 88100
        • Azienda Ospedaliero-Universitaria Renato Dulbecco
    • LU
      • Lucca, LU, Italy, 55100
        • Ospedale Civile Campo di Marte
    • MI
      • Milano, MI, Italy, 20132
        • Istituto Scientifico San Raffaele
    • RM
      • Roma, RM, Italy, 00161
        • Policlinico Umberto I Seconda Clinica Medica
  • Japan
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital, Diabetes and Metabolic
      • Chiba, Japan, 271-0077
        • New Tokyo Heart Clinic_Matsudo-shi, Chiba,
      • Ehime, Japan, 790-0024
        • Ehime Prefectural Central Hospital
      • Fukui, Japan, 910-0846
        • Fukui Prefectural Hospital
      • Fukuoka, Japan, 816-0864
        • Fukuoka Tokushukai Hospital
      • Ibaraki, Japan, 311-0113
        • Naka Kinen Clinic
      • Kyoto, Japan, 611-0041
        • Uji Tokushukai Medical Center
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Miyagi, Japan, 983-0039
        • Shinden Higashi Clinic_Miyagi
      • Nagano, Japan, 390-8621
        • Shinshu University Hospital
      • Osaka, Japan, 569-1045
        • Takatsuki Red Cross Hospital
      • Osaka, Japan, 564-0013
        • Saiseikai Suita Hospital
      • Osaka, Japan, 565-0871
        • Osaka University Hospital_Osaka
      • Osaka, Japan, 574-0074
        • Nozaki Tokushukai Hospital
      • Saga-shi, Saga, Japan, 849-8501
        • Saga University Hospital, Department of Cardiology
      • Sapporo-shi, Hokkaido, Japan, 062-0003
        • Hanaoka Seishu Memorial Hospital
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Kagawa Prefectural Central Hospital, Cardiovascular Medicine
      • Tochigi, Japan, 323-0022
        • Oyama East Clinic
      • Tokorozawa-shi, Saitama, Japan, 356-1142
        • Tokorozawa Heart Center
      • Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Tokyo, Japan, 192-0918
        • Minamino Cardiovascular Hospital
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital_Tokyo
      • Tokyo, Japan, 177-0041
        • Sugawara Clinic
      • Tokyo, Japan, 196-0003
        • Tokyo Nishi Tokushukai Hospital
    • Kumamoto, Japan
      • Kumamoto-shi, Kumamoto, Japan, Japan, 862-0976
        • Jinnouchi Hospital
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan, 880-0034
        • Heiwadai Hospital
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Korea, Republic of, 471-101
        • Hanyang University GURI Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06591
        • Seoul Saint Mary's Hospital
      • Seoul, Korea, Republic of, 139-827
        • Nowon Eulji Medical Center, Eulji University
  • Malaysia
      • Alor Setar, Malaysia, 05460
        • Hospital Sultanah Bahiyah
      • Kuching, Malaysia, 93586
        • Sarawak General Hospital
      • Sarawak, Malaysia, 98000
        • Hospital Miri
      • Seremban, Malaysia, 70300
        • Hospital Tuanku Jaafar
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Hospital Raja Perempuan Zainab II
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan
    • Sarawak
      • Kota Samarahan, Sarawak, Malaysia, 94300
        • Sarawak Heart Centre
    • Selangor
      • Sungai Buloh, Selangor, Malaysia, 47000
        • University Technology MARA (UiTM) - Puncak Alam
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Wilayah Persekutuan Putrajaya
      • Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
        • Hospital Putrajaya
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Centro de Investigación Cardiometabólica de Aguascalientes
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC
      • Guadalajara, Jalisco, Mexico, 44650
        • Arechavaleta Granell María del Rosario
    • México, D.F.
      • Tlalpan, México, D.F., Mexico, 14080
        • Centro de Atención Integral al Paciente con Diabetes
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64060
        • Cardiolink Clin Trials S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64020
        • Internal Medicine Clin Trials
      • San Nicolas de los Garza, Nuevo León, Mexico, 66465
        • Unidad Medica para la Salud Integral (UMSI)
    • Sonora
      • Hermosillo, Sonora, Mexico, 83280
        • Investigación Médica Sonora S.C.
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Medical Care and Research S. A de C.V
      • Mérida, Yucatan, Mexico, 97070
        • Centro de Desarrollo Biomédico S.C.P.
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • EME Red Hospitalaria
  • Netherlands
      • Amersfoort, Netherlands, 3813 TZ
        • Meander Medisch Centrum
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam UMC Lokatie VUMC
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuizen Apeldoorn
      • Delft, Netherlands, 2625 AD
        • Reinier de Graaf Gasthuis
      • Eindhoven, Netherlands, 5631 BM
        • Máxima Medisch Centrum
      • Groningen, Netherlands, 9728 NT
        • Martini Ziekenhuis
      • Hoogeveen, Netherlands, 7909 AA
        • Bethesda Diabetes Research Center en Bethesda ziekenhuis
      • Maastricht, Netherlands, 6229 HX
        • Maastricht Universitair Medisch Centrum
      • Nijmegen, Netherlands, 6525 GA
        • Radboudumc
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
  • Romania
      • Bacau, Romania, 600154
        • CMI Dr. Pletea Noemi SRL
      • Bucharest, Romania, 051811
        • Diabet Med SRL
      • Galati, Romania, 800578
        • Clinical Emergency Sf. Apostol Andrei Hospital
      • Iasi, Romania, 700111
        • Spitalul Clinic Judetean de Urgente Sf. Spiridon
      • Sibiu, Romania, 550371
        • SC Gensan SRL, Policlinica ASTRA
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400006
        • Clinic of Diabetes Cluj
    • Dambovita
      • Targoviste, Dambovita, Romania, 130083
        • Spitalul Judetean de Urgenta Targoviste
    • Mures
      • Targu Mures, Mures, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Targu Mures
      • Tirgu Mures, Mures, Romania, 540142
        • Sc Mediab Srl
    • Prahova
      • Ploiesti, Prahova, Romania, 100018
        • Novus Medical Clinica SRL
      • Ploiesti, Prahova, Romania, 100342
        • CMI Dr. Busegeanu Mihaela Magdalena
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • City Hospital #5
      • Kazan, Russian Federation, 420012
        • Kazan Federal University
      • Kazan, Russian Federation, 420111
        • LLC "Clinic of Aesthetic Medicine & Laser Technologies"
      • Kemerovo, Russian Federation, 650066
        • SAHI Kuzbass Hospital(former Regional clinical hospital)
      • Moscow, Russian Federation, 119435
        • Setchenov First Moscow State Medical University
      • Moscow, Russian Federation, 117292
        • Friendship University of Russia
      • Novosibirsk, Russian Federation, 630087
        • State Novosibirsk Regional Clinical Hospital
      • Novosibirsk, Russian Federation, 630099
        • Limited Law Company "Healthy Family" Medicine Center"
      • Penza, Russian Federation, 440052
        • Penza Regional Clinical Hospital named after N.N. Burdenko
      • Saint Petersburg, Russian Federation, 194156
        • Aurora MedFort LLC
      • Saint-Petersburg, Russian Federation, 194354
        • City Consultative & Diagnostic Centre #1
      • Saint-Petersburg, Russian Federation, 197110
        • Consultative & Diagnostic Center with a Outpatient Hospital
      • Saint-Petersburg, Russian Federation, 191119
        • SPb SBHI City Outpatient clinic #37
      • Saratov, Russian Federation, 410053
        • Saratov regional clinical hospital
      • Saratov, Russian Federation, 410039
        • Regional clinical cardiology dispensary
      • St. Petersburg, Russian Federation, 194354
        • SPb SBHI City Multifield Hospital #2
      • Tomsk, Russian Federation, 634050
        • Siberian State Medical University
      • Ulianovsk, Russian Federation, 432063
        • Ulianovsk Regional Clinical Hospital
      • Yaroslavl, Russian Federation, 150062
        • Yaroslavl Regional Hospital
      • Yoshkar-Ola, Russian Federation, 424004
        • Polyclinic #2 in Yoshkar-Ola
    • Russia
      • Tumen, Russia, Russian Federation, 625023
        • Tumen State Medical University
  • Serbia
      • Belgrade, Serbia, 11000
        • Military Medical Academy
      • Belgrade, Serbia, 11000
        • Endocrinology, Diabetes and Metabolism Diseases Clinic
      • Belgrade, Serbia, 11000
        • CHC Zvezdara, Clinical department for endocrinology
      • Kragujevac, Serbia, 34000
        • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
      • Nis, Serbia, 18000
        • Clinical Centre Nis, Endocrinology, Diabetes and Metabolism
      • Zajecar, Serbia, 19000
        • Policlinic for diabetes
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
  • Slovakia
      • Bratislava, Slovakia, 831 01
        • Metabolicke Centrum MUDr. Katariny Raslovej s.r.o.
      • Bratislava, Slovakia, 83103
        • Diabetologicka ambulancia MediTask, s.r.o
      • Bratislava, Slovakia, 833 05
        • Diabetologická ambulancia - Nemocnica akademika L. Derera, UNB
      • Kosice, Slovakia, 040 01
        • HUMAN-CARE s.r.o.
      • Kosice, Slovakia, 040 22
        • CARDIO D&R, s.r.o.
      • Krompachy, Slovakia, 05342
        • Nemocnica Krompachy spol. s r.o Diabetol. amb. MD Gmitrov
      • Nitra, Slovakia, 949 01
        • Diabetologicka ambulancia MUDr. Katarina Plevova, s.r.o.
      • Poprad, Slovakia, 05801
        • DENTAVIA s.r.o.
      • Prievidza, Slovakia, 97101
        • MUDr. Jan Culak, s.r.o.
      • Rimavska Sobota, Slovakia, 97901
        • Kardiologicka a interna ambulancia
      • Roznava, Slovakia, 04801
        • Tatratrial s.r.o.
      • Vrutky, Slovakia, 038 61
        • IRIDIA s.r.o.
  • South Africa
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
        • Diabetes Care Centre & CDE Centre
      • Johannesburg, Gauteng, South Africa, 1820
        • Deepak Lakha
      • Johannesburg, Gauteng, South Africa, 1827
        • Hemant Makan
      • Johannesburg, Gauteng, South Africa, 1818
        • Soweto Clinical Trial Centre
      • Johannesburg, Gauteng, South Africa, 1619
        • Peermed Clinical Trial Centre
      • Johannesburg, Gauteng, South Africa, 1829
        • Deepak Lakha
      • Johannesburg, Gauteng, South Africa, 2198
        • Centre for Diabetes
      • Pretoria, Gauteng, South Africa, 0083
        • Dr Seeber
      • Pretoria, Gauteng, South Africa, 0181
        • Prof P. Joshi
    • KwaZulu-Natal
      • Berea, KwaZulu-Natal, South Africa, 4091
        • Dr H Bacus
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Dr Pillay's Rooms
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Dr A Amod
      • Durban, KwaZulu-Natal, South Africa, 4170
        • Dr T Padayachee
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Diabetes Clinical Trials Unit
      • Cape Town, Western Cape, South Africa, 7925
        • UCT Clinical Research Centre
  • Spain
      • Antequera, Spain, 29200
        • Hospital Comarcal de Antequera
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Burela, Spain, 27880
        • Hospital Público da Mariña
      • Córdoba, Spain, 14004
        • Hospital Reina Sofia
      • La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Las Palmas de Gran Canaria, Spain, 35019
        • Hospital Universitario de Gran Canaria Doctor Negrín
      • Lugo, Spain, 27004
        • Hospital Ribera Polusa
      • Málaga, Spain, 29006
        • Hospital Clínico Virgen de la Victoria
      • Pozuelo de Alarcon, Spain, 28223
        • Hospital Quirón
      • Sanlúcar de Barrameda, Spain, 11540
        • Hospital Virgen del Camino - Sanlúcar de Barrameda
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Sevilla, Spain, 41009
        • Hospital Virgen de la Macarena
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Fundación Alcorcón
  • Taiwan
      • Changhua City, Taiwan, 500
        • Changhua Christian Hospital
      • Taichung City, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taoyuan city, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou Branch
  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10330
        • Police General Hospital
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital_Bangkok
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital-Cardiovascular metabolic Center
      • Bangkok, Thailand, 10700
        • Siriraj Hospital_Bangkok_1
      • Nakhon Ratchasima, Thailand, 30000
        • Maharat Nakhon Ratchasima Hospital
      • Songkla, Thailand, 90110
        • Songklanagarind Hospital
    • Bangkok
      • Bangkoknoi, Bangkok, Bangkok, Thailand, 10700
        • Siriraj Hospital_Bangkoknoi, Bangkok
    • Mueang Chiang Mai District
      • Chiang Mai, Mueang Chiang Mai District, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
  • Turkey
      • Adana, Turkey, 01000
        • T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
      • Ankara, Turkey, 06010
        • Gulhane Egitim Arastirma Hastanesi
      • Bursa, Turkey, 16310
        • T.C. Saglik Bakanligi Bursa Il Saglik Mudurlugu Yuksek Ihtıs
      • Erzurum, Turkey, 25240
        • Ataturk Universitesi Tip Fakultesi
      • Eskisehir, Turkey, 26040
        • Eskisehir Osmangazi University School of Medicine
      • Hatay, Turkey, 31060
        • Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
      • Istanbul, Turkey, 34722
        • T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
      • Istanbul, Turkey, 34096
        • Haseki Egitim ve Arastirma Hastanesi_ISTANBUL
      • Istanbul, Turkey, 34303
        • Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi
      • Izmir, Turkey, 35340
        • Dokuz Eylul University Medical Faculty
      • Kayseri, Turkey, 38039
        • Erciyes Universitesi Tip Fakultesi
      • Sivas, Turkey, 58140
        • Sivas Cumhuriyet Univesity Endocrinology Department
      • Trabzon, Turkey, 61080
        • Karadeniz University School of Medicine-Adult Endocrinology
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Cherkasy Regional Hospital of Cherkasy Reg. Council
      • Chernivtsi, Ukraine, 58022
        • RMI "Chernivtsi Regional Endocrinology Centre"
      • Dnipro, Ukraine, 49005
        • CI Dnipropetrovsk Regional Hospital
      • Kyiv, Ukraine, 03049
        • Clinical Hosp on the railway line №2 branch PHC JSC Ukrzaliz
      • Kyiv, Ukraine, 04053
        • SRI "Centre of Innovative Medical Technologies of the NASU"
      • Lviv, Ukraine, 79010
        • Lviv Regional Endocrinology Diagnostic and Treatment Centre
      • Odesa, Ukraine, 65025
        • Odesa Regional Clinical Hospital
      • Poltava, Ukraine, 36039
        • CI "1st City Clinical Hospital of Poltava City Council"
      • Uzhhorod, Ukraine, 88000
        • Transcarpathian Regional Clinical Hospital of A. Novak
      • Zhytomyr, Ukraine, 10002
        • Zhytomir Regional Clinical Hospital
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • The Health Centre
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital_Cambridge
      • Chippenham, United Kingdom, SN15 1HP
        • Hathaway Surgery
      • Coventry, United Kingdom, CV2 2DX
        • WISDEM Centre
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • Glasgow, United Kingdom, G31 2ER
        • Glasgow Clinical Research Facility
      • Harrogate, United Kingdom, HG2 7SX
        • Harrogate District Hospital
      • Hinckley, United Kingdom, LE10 2SE
        • Burbage Surgery
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • London, United Kingdom, NW3 2QG
        • Royal Free - Diabetes
      • Manchester, United Kingdom, M8 5RB
        • Diabetes Centre North Manchester General Hospital
      • Norfolk, United Kingdom, NR4 7UQ
        • The Norfolk and Norwich University Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • University Dept of Medicine, Derriford Hospital, Plymouth
      • Redhill, United Kingdom, RH1 5RH
        • East Surrey Hospital
      • Soham, United Kingdom, CB7 5JD
        • The Staploe Medical Centre
      • Swansea, United Kingdom, SA2 8PP
        • Joint Clinical Research Facility - Swansea
    • Surrey
      • Addlestone, Surrey, United Kingdom, KT15 2BH
        • Crouch Oak Family Practice
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Healthscan Clinical Trials,LLC.
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Medical Investigations, Inc.
      • Searcy, Arkansas, United States, 72143
        • Unity Health-Searcy Medical Center
    • California
      • Fresno, California, United States, 93721-1443
        • B&K Medical Research Center
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • La Mesa, California, United States, 91942
        • Diabetes & Endocrine Associates
      • Lancaster, California, United States, 93534
        • First Valley Medical Group
      • Los Alamitos, California, United States, 90720
        • Pacific Clinical Studies
      • Mission Hills, California, United States, 91345
        • Facey Medical Foundation
      • Monterey, California, United States, 93940
        • Monterey Endocrine & Diabetes Institute, Inc
      • Palm Springs, California, United States, 92262
        • Desert Oasis Hlthcr Med Group
      • San Diego, California, United States, 92111
        • San Diego Family Care
      • Torrance, California, United States, 90502
        • Lundquist Inst-Biomed Innovtn
      • Ventura, California, United States, 93003
        • Coastal Metabolic Research Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mount Reg VA Med-DN
      • Denver, Colorado, United States, 80246
        • Creekside Endocrine Associates, PC
      • Golden, Colorado, United States, 80401
        • New West Physicians,Inc.
    • Florida
      • Boca Raton, Florida, United States, 33433
        • East Coast Medical Associates, Inc.
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc._New Port Richey
      • Orlando, Florida, United States, 32804
        • AdventHealth Diab Inst
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Ellipsis Group
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Assoc. LLC
      • Roswell, Georgia, United States, 30076
        • Endo Res Solutions Inc
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Med Res Inst
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Rocky Mountain Diab&Osteo Ctr
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Clinical Invest Special_Gurnee
    • Indiana
      • Franklin, Indiana, United States, 46131
        • American Health Network of IN LLC_Franklin
      • Greenfield, Indiana, United States, 46140
        • American Health Network of Indiana, LLC_Greenfield
      • Michigan City, Indiana, United States, 46360
        • Franciscan Health Michigan City
      • Muncie, Indiana, United States, 47304
        • American Health Network of IN LLC
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diab & Endo Res Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington LLC
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
      • Louisville, Kentucky, United States, 40206
        • Robley Rex VA Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
      • Slidell, Louisiana, United States, 70461-4231
        • Ileana J Tandron APMC
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Northern Pines Hlth Ctr, PC
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Phys. Clinic
      • Omaha, Nebraska, United States, 68198-3020
        • Univ of Nebraska Medical CTR
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Inc-Vegas
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
      • Nashua, New Hampshire, United States, 03060
        • Southern New Hampshire Diabetes and Endocrinology
    • New York
      • Albany, New York, United States, 12203
        • Albany Medical College - Endo
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group, LLP
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mountain Diabetes & Endocrine Center
      • Burlington, North Carolina, United States, 27215
        • Kernodle Clin Dpt-Pvt Diagnost
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences LLC
      • Greenville, North Carolina, United States, 27834
        • Physicians East Endocrinology
      • New Bern, North Carolina, United States, 28562
        • Eastern Nephr Assoc, PLLC
      • Whiteville, North Carolina, United States, 28472
        • Whiteville Medical Associates
      • Wilmington, North Carolina, United States, 28401
        • Accellacare
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
    • Ohio
      • Marion, Ohio, United States, 43302
        • Awasty Research Network
      • Maumee, Ohio, United States, 43537
        • Advanced Med Res Maumee
      • Mentor, Ohio, United States, 44060
        • Your Diabetes Endocrine Nutrition Group, Inc.
      • Twinsburg, Ohio, United States, 44087
        • Twinsburg Family Health Center
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Lynn Institute of Norman
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Medical Group Inc
      • McMurray, Pennsylvania, United States, 15317
        • Primary Care Research South, Inc
      • Philadelphia, Pennsylvania, United States, 19114
        • Aria Endocrine Metabolic Assoc
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Physicians Inc.
    • South Carolina
      • Murrells Inlet, South Carolina, United States, 29576
        • The Diabetes Center, LLC
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Health Specialists
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Univ Diab & Endo Consultants
      • Chattanooga, Tennessee, United States, 37404
        • Michael L Reeves, MD
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Nashville, Tennessee, United States, 37203
        • MidState Endocrine Associates
      • Nashville, Tennessee, United States, 37203
        • InvestiClin Research
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Diab Obes Clin Tri
      • Tullahoma, Tennessee, United States, 37388
        • Trinity Clinical Research LLC
    • Texas
      • Arlington, Texas, United States, 76012-4637
        • Arlington Family Res. Ctr Inc
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Austin, Texas, United States, 78749
        • Texas Diabetes & Endocrinology
      • Austin, Texas, United States, 78731
        • Texas Diabetes & Endocrinology, P.A._Austin
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, United States, 75390-9302
        • UT Southwestern Med Cntr
      • Fort Worth, Texas, United States, 76132
        • Diabetes and Thyroid Ctr of FW
      • Houston, Texas, United States, 77024
        • PrimeCare Medical Group
      • Houston, Texas, United States, 77061
        • Synergy Groups Medical
      • Longview, Texas, United States, 75605
        • DCOL Ctr for Clin Res
      • Midland, Texas, United States, 79707
        • Midland Clinical Research Center
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology, P.A._Austin
      • Sugar Land, Texas, United States, 77478
        • Simcare Medical Research, LLC
      • Waco, Texas, United States, 76708
        • Hillcrest Family Health Center
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • University of Vermont Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates
      • Winchester, Virginia, United States, 22601-3834
        • Selma Medical Associates
    • Wisconsin
      • Kenosha, Wisconsin, United States, 60031
        • Clinical Inv Spec, Inc.Kenosha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral semaglutide
One tablet daily for 3.5 to 5 years
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 Comparator: Placebo
One tablet daily for 3.5 to 5 years
Drug: Placebo (semaglutide)
Placebo tablets to be taken with water at the same time every morning in a fasting state

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first occurrence of a composite endpoint
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)

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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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 Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)

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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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)
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)
Time to first occurrence of non-fatal stroke
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)
Time to first occurrence of heart failure requiring hospitalisation
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)
Time to first occurrence of urgent heart failure visit
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)
Time to first occurrence of coronary revascularisation
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)
Time to first occurrence of unstable angina requiring hospitalisation
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)
Time to occurrence of renal death
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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)
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)
Time to first occurrence of acute limb ischemia
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)
Time to first occurrence of chronic limb ischemia
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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)
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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)
Time Frame: From randomisation (week 0) to 2 years
Percent points
From randomisation (week 0) to 2 years
Change in body weight
Time Frame: From randomisation (week 0) to 2 years
Kilograms
From randomisation (week 0) to 2 years
Number of severe hypoglycaemic episodes
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
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
Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more)
Months
From randomisation (week 0) to end-of-trial (up to 61 months or more)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Estimated)

July 29, 2024

Study Completion (Estimated)

July 29, 2024

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX9924-4473
  • 2018-003141-42 (Registry Identifier: European Medicines Agency (EudraCT))
  • U1111-1218-5368 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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