A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes
NCT ID: NCT03914326
Last Updated: 2025-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
9651 participants
INTERVENTIONAL
2019-06-17
2024-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oral semaglutide
One tablet daily for 3.5 to 5 years
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
One tablet daily for 3.5 to 5 years
Placebo (semaglutide)
Placebo tablets to be taken with water at the same time every morning in a fasting state
Interventions
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Semaglutide
Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state
Placebo (semaglutide)
Placebo tablets to be taken with water at the same time every morning in a fasting state
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Chambliss Clinical Trials, LLC
Montgomery, Alabama, United States
Medical Investigations, Inc.
Little Rock, Arkansas, United States
Unity Health-Searcy Medical Center
Searcy, Arkansas, United States
B&K Medical Research Center
Fresno, California, United States
University of Vermont Medical Center
Fullerton, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Diabetes & Endocrine Associates
La Mesa, California, United States
First Valley Medical Group
Lancaster, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Monterey Endocrine & Diabetes Institute, Inc
Monterey, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
San Diego Family Care
San Diego, California, United States
Lundquist Inst-Biomed Innovtn
Torrance, California, United States
Coastal Metabolic Research Center
Ventura, California, United States
Rocky Mount Reg VA Med-DN
Aurora, Colorado, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
New West Physicians,Inc.
Golden, Colorado, United States
East Coast Medical Associates, Inc.
Boca Raton, Florida, United States
Suncoast Clin Res Port Richey
New Port Richey, Florida, United States
AdventHealth Diab Inst
Orlando, Florida, United States
Ellipsis Group
Alpharetta, Georgia, United States
Physicians Research Assoc. LLC
Lawrenceville, Georgia, United States
Endo Res Solutions Inc
Roswell, Georgia, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Rocky Mountain Diab&Osteo Ctr
Idaho Falls, Idaho, United States
Clinical Invest Special_Gurnee
Gurnee, Illinois, United States
American Health Network of IN LLC_Franklin
Franklin, Indiana, United States
American Health Network of Indiana, LLC_Greenfield
Greenfield, Indiana, United States
Franciscan Health Michigan City
Michigan City, Indiana, United States
American Health Network of IN LLC
Muncie, Indiana, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
The Research Group of Lexington LLC
Lexington, Kentucky, United States
Robley Rex VA Medical Center
Louisville, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Ileana J Tandron APMC
Slidell, Louisiana, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
Methodist Phys. Clinic
Omaha, Nebraska, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
AMC Community Endocrinology
Albany, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Great Lakes Medical Research
Westfield, New York, United States
Mountain Diabetes & Endocrine Center
Asheville, North Carolina, United States
Kernodle Clin Dpt-Pvt Diagnost
Burlington, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Physicians East Endocrinology
Greenville, North Carolina, United States
Eastern Nephr Assoc, PLLC
New Bern, North Carolina, United States
Whiteville Medical Associates
Whiteville, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Awasty Research Network,LLC
Marion, Ohio, United States
Advanced Med Res Maumee
Maumee, Ohio, United States
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, United States
Twinsburg Family Health Center
Twinsburg, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Heritage Valley Medical Group Inc
Beaver, Pennsylvania, United States
Primary Care Research South, Inc
McMurray, Pennsylvania, United States
Aria Endocrine Metabolic Assoc
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, United States
The Diabetes Center, LLC
Murrells Inlet, South Carolina, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Michael L Reeves, MD
Chattanooga, Tennessee, United States
Univ Diab & Endo Consultants
Chattanooga, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
InvestiClin Research
Nashville, Tennessee, United States
MidState Endocrine Associates
Nashville, Tennessee, United States
Vanderbilt Diab Obes Clin Tri
Nashville, Tennessee, United States
Trinity Clinical Research LLC
Tullahoma, Tennessee, United States
Arlington Family Res. Ctr Inc
Arlington, Texas, United States
Central Texas Clinical Research
Austin, Texas, United States
Texas Diabetes & Endocrinology, P.A._Austin
Austin, Texas, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
Diabetes and Thyroid Ctr of FW
Fort Worth, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
Synergy Groups Medical
Houston, Texas, United States
DCOL Ctr for Clin Res
Longview, Texas, United States
Midland Clinical Research Center
Midland, Texas, United States
Texas Diabetes & Endocrinology, P.A._Austin
Round Rock, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Hillcrest Family Health Center
Waco, Texas, United States
Dominion Medical Associates
Richmond, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
Clinical Investigation Spec. Kenosha
Kenosha, Wisconsin, United States
Internal medicine department
Algiers, , Algeria
endocrino-diabetology department, Hospital IBN BADIS.
Constantine, , Algeria
Internal Medecine department CHU Ibn Badis
Constantine, , Algeria
EHU 1st November 1954
Oran, , Algeria
Internal Medicine departement CHU Oran
Oran, , Algeria
Department of internal of medicine, CHU Setif
Sétif, , Algeria
Centro Médico CIMEL
Lanús Este, Buenos Aires, Argentina
DIM Clinica Privada
Buenos Aires, , Argentina
Centro Medico Lebensohn
Buenos Aires, , Argentina
Hospital Italiano
Buenos Aires, , Argentina
Centro de Investigaciones Metabólicas
Capital Federal, , Argentina
Centro Diabetologico Cordoba Dr. Waitman
Córdoba, , Argentina
Centro médico privado Cemaic
Córdoba, , Argentina
Instituto Médico DAMIC
Córdoba, , Argentina
Centro Médico Privado San Vicente Diabetes
Córdoba, , Argentina
Centro Médico CIMEL
Lanús Este, , Argentina
Instituto de Investigaciones Clinicas
Mar del Plata, , Argentina
Sanatorio Britanico S.A.
Rosario, Santa Fe, , Argentina
Univ.-Klinik für Innere Medizin
Graz, , Austria
Medizinische Universität Innsbruck
Innsbruck, , Austria
Fließer-Görzer [Ordination]
Saint Stefan, , Austria
Klinik Hietzing
Vienna, , Austria
Klinik Ottakring
Vienna, , Austria
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
Bonheiden, , Belgium
UZ Antwerpen - UZA - Department of Endocrinology
Edegem, , Belgium
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, , Belgium
UZ Gent - Endocrinologie - Diabetologie
Ghent, , Belgium
AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
Kortrijk, , Belgium
UZ Leuven - Endocrinology
Leuven, , Belgium
AZ Delta - Roeselare - Diabeteskliniek
Roeselare, , Belgium
AZ Delta - Roeselare
Roeselare, , Belgium
Hospital do Coração do Brasil
Brasília, Federal District, Brazil
Cline Research Center
Curitiba, Paraná, Brazil
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
Curitiba, Paraná, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, Brazil
i9 Pesquisas Clínicas
Campinas, São Paulo, Brazil
Instituto de Pesquisa Clinica (IPEC)
São Paulo, São Paulo, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, Brazil
C-endo Diab Endo Clin Calgery
Calgary, Alberta, Canada
Vancouver General Hospital_Vancouver_0
Vancouver, British Columbia, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
LMC Diabetes & Endocrinology (Barrie)
Barrie, Ontario, Canada
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, Canada
Aggarwal and Assoc Ltd.
Brampton, Ontario, Canada
LMC Clinical Res Thornhill
Concord, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
My Endo Diabetes & Endo Cent
Markham, Ontario, Canada
Bluewater Clin Res Group, Inc.
Sarnia, Ontario, Canada
Bluewater Clin Res Group,Inc
Sarnia, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
UHN-Toronto General Hospital
Toronto, Ontario, Canada
Diabetes Heart Research Centre
Toronto, Ontario, Canada
Manna Research Mirabel
Mirabel, Quebec, Canada
Applied Med Inf Res
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, , Canada
Peking University People's Hospital-Endocrinology
Beijing, Beijing Municipality, China
Cangzhou People's Hospital-Endocrinology
Cangzhou, Hebei, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China
The Affiliated Hospital of Jiangsu University_Zhenjiang
Zhenjiang, Jiangsu, China
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, China
Shanghai Fifth People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, China
Clinica de la Costa
Barranquilla, Atlántico, Colombia
Fundación Hospital Universidad del Norte
Soledad, Barranquilla, Colombia
Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia
Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander Department, Colombia
Fundacion Valle del Lili
Cali, Valle del Cauca Department, Colombia
Clinica de la Costa
Barranquilla, , Colombia
Fundación Centro de Obesidad y Metabolismo COMETA
Pasto, , Colombia
Poliklinika Solmed
Zagreb, City of Zagreb, Croatia
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
Krapinske Toplice, , Croatia
Klinicki bolnicki centar Osijek
Osijek, , Croatia
Opca bolnica Pula
Pula, , Croatia
KBC Rijeka, Zavod za endokrinologiju
Rijeka, , Croatia
KBC Split / Krizine / Dijabetes
Split, , Croatia
Opca bolnica Varazdin_Endocrinology
Varaždin, , Croatia
Opca bolnica Zadar_Endocrinology
Zadar, , Croatia
KB Merkur - Sveucilisna klinika Vuk Vrhovac
Zagreb, , Croatia
KB Dubrava, Zavod za endokrinologiju i dijabetes
Zagreb, , Croatia
Fakultní nemocnice U sv. Anny v Brně
Brno, , Czechia
Intendia klinika
Chrudim, , Czechia
FN Hradec Kralove
Hradec Králové, , Czechia
Diabetologicka a Interni Ambulance MUDr. Jan Vrkoc s.r.o.
Moravská Ostrava, , Czechia
Ambulance DIA - INTERNA s.r.o.
Ostrava, , Czechia
Diabetologicka ambulance Plzen
Pilsen, , Czechia
MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
Pilsen, , Czechia
MUDr. Jitka Zemanova diabetologie a interna
Plzeň - Východní Předměstí, , Czechia
DIALINE s.r.o.
Plzeň 3, , Czechia
Institut klinicke a experimentalni mediciny_Praha
Prague, , Czechia
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, , Denmark
Bispebjerg Hospital, IC-Forskning
Copenhagen, , Denmark
Hillerød Endokrinologisk amb. H0652
Hillerød, , Denmark
Slagelse Sygehus Ambulatorium for hjertesygdomme
Slagelse, , Denmark
Svendborg Sygehus - Endokrinologisk afdeling
Svendborg, , Denmark
Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz
Besançon, , France
Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
Dijon, , France
Les Hopitaux de Chartres-Hopital Louis Pasteur
Le Coudray, , France
Assistance Publique Hopitaux de Marseille-Hopital de La Conception
Marseille, , France
Centre Hospitalier de Narbonne
Narbonne, , France
Ap-Hp-Hopital Bichat-Claude Bernard-1
Paris, , France
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
Pessac, , France
Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-1
Strasbourg, , France
Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden)
Dresden, , Germany
Uniklinik TU Dresden - Med. Klinik III
Dresden, , Germany
Praxis Dr. med. M. Esser
Essen, , Germany
Zentrum für klinische Forschung, Dr. med. Lüdemann
Falkensee, , Germany
Diabetologische Schwerpunktpraxis Harburg- Dr. med.Paschen,
Hamburg, , Germany
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, , Germany
Praxisgemeinschaft Jerichow
Jerichow, , Germany
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, , Germany
Die Praxis am Ludwigsplatz
Ludwigshafen, , Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, , Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, , Germany
Praxis Dr. med. Wenzl-Bauer
Rehlingen-Siersburg, , Germany
VvP Kliniken gGmbH Marienhospital Stuttgart - Innere Medizin I
Stuttgart, , Germany
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
Witten, , Germany
Prince of Wales Hospital
Shatin, New Territories, , Hong Kong
Osmania General Hospital
Hyderabad, A.P., India
Sunshine Hospital
Hyderabad, Andhra Pradesh, India
Care Outpatient Centre
Hyderabad, Andhra Pradesh, India
Ramdev Rao Hospital
Hyderabad, Andhra Pradesh, India
Apollo Excelcare Hospital, Guwahati
Guwahati, Assam, India
Apollo Excelcare Hospital
Guwahati, Assam, India
HCG Hospitals
Ahmedabad, Gujarat, India
Dr. Jivraj Mehta Health Foundation
Ahmedabad, Gujarat, India
PGIMS Rohtak
Rohtak, Haryana, India
Ramaiah Memorial Hospital
Bangalore, Karnataka, India
Lifecare Hospital and Research Centre
Bangalore, Karnataka, India
Calicut Medical College
Kozhikode, Kerala, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
Goa Medical College
Goa, Maharashtra, India
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, India
BYL Nair Hospital and T N Medical College Department of endo
Mumbai, Maharashtra, India
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, India
BSES MG hospital
Mumbai, Maharashtra, India
Fortis Hospital Mulund
Mumbai, Maharashtra, India
Fortis Hospital, Mulund, Mumbai
Mumbai, Maharashtra, India
chelleram Diabetes Institute
Pune, Maharashtra, India
Inamdar Multispeciality Hospital
Pune, Maharashtra, India
All India Institute of Medical Sciences
New Dehli, New Delhi, India
Kanungo Institute of Diabetes Specialities Pvt Ltd
Bhubaneswar, Odisha, India
Dayanand Medical College & Hospital
Ludhiana, Punjab, India
Christian Medical College and Hospital
Ludhiana, Punjab, India
Fortis Heart Institute and Multispeciality Hospital
Mohali, Punjab, India
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, India
Kg Hospital and Post Graduate Medical Institute
Coimbatore, Tamil Nadu, India
Christian Medical College Hospital, Vellore
Ranipet, Tamil Nadu, India
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, India
Gandhi Hospital & Medical college
Hyderabad, Telangana, India
Osmania General Hospital
Hyderabad, Telangana, India
Ramdev Rao Hospital
Hyderabad, Telangana, India
SSKM
Kolkata, West Bengal, India
Apollo Gleneagles Hospital
Kolkata, West Bengal, India
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, India
Lady Hardinge Medical College
New Delhi, , India
North Delhi Diabetes Centre
New Delhi, , India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, , India
Rambam MC - Diabetes and obesity center of excellence
Haifa, , Israel
Hadassah Ein Karam MC - Diabetes Unit
Jerusalem, , Israel
Clalit HMO Hamoshava Jerusalem
Jerusalem, , Israel
Meir MC - Diabetes unit
Kfar Saba, , Israel
Western Galilee MC - Institute of Diabetes
Nahariya, , Israel
Rabin MC Beilinson - Endo unit
Petah Tikva, , Israel
Sourasky MC - Institute of Endocrinology, metabolism and hypertension
Tel Aviv, , Israel
Endrocrinolgy Clinic - Sheba Medical Center
Tel Litwinsky, , Israel
Sheba MC - Endocrinology Clinic
Tel Litwinsky, , Israel
Sheba MC - Cardiology Clinical Research Unit
Tel Litwinsky, , Israel
Sheba Medica Center - Clinical Research Unit
Tel Litwinsky, , Israel
A.O.U. Consorziale Policlinico di Bari
Bari, BA, Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Cz, Italy
Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
Lucca, LU, Italy
Istituto Scientifico San Raffaele
Milan, MI, Italy
Policlinico Umberto I Seconda Clinica Medica
Roma, RM, Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti Scalo, , Italy
Centro Cardiologico Monzino
Milan, , Italy
Università Federico II Dip. di Med. Clinica e Chirurgia Ed 1
Napoli, , Italy
Azienda Ospedaliera di Padova Malatt.Metab
Padua, , Italy
Dip. di Medicina Interna Policlinico Universitario Palermo
Palermo, , Italy
Policlinico Universitario Paolo Giaccone
Palermo, , Italy
Policlinico Universitario Tor Vergata
Roma, , Italy
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, Japan
Jinnouchi Hospital
Kumamoto, Kumamoto, Japan, Japan
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
The University of Tokyo Hospital, Diabetes and Metabolic
Bunkyo-ku, Tokyo, , Japan
New Tokyo Heart Clinic_Matsudo-shi, Chiba,
Chiba, , Japan
Ehime Prefectural Central Hospital
Ehime, , Japan
Ehime Prefectural Central Hosp
Ehime, , Japan
Fukui Prefectural Hospital
Fukui, , Japan
Fukuoka Tokushukai Hospital
Fukuoka, , Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, , Japan
Naka Kinen Clinic
Ibaraki, , Japan
Uji Tokushukai Medical Center_Cardiovascular Medicine
Kyoto, , Japan
Kyoto University Hospital
Kyoto-shi, Kyoto, , Japan
Shinden Higashi Clinic_Miyagi
Miyagi, , Japan
Shinshu University Hospital
Nagano, , Japan
Saiseikai Suita Hospital
Osaka, , Japan
Osaka University Hospital_Osaka
Osaka, , Japan
Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.
Osaka, , Japan
Takatsuki Red Cross Hospital
Osaka, , Japan
Nozaki Tokushukai Hospital_Internal medicine
Osaka, , Japan
Saga University Hospital, Department of Cardiology
Saga-shi, Saga, , Japan
Hanaoka Seishu Memorial Hosp._Cardiovascular Medicine
Sapporo-shi, Hokkaido, , Japan
Kagawa Prefectural Central Hospital, Cardiovascular Medicine
Takamatsu-shi, Kagawa, , Japan
Oyama East Clinic_Internal Medicine
Tochigi, , Japan
Oyama East Clinic
Tochigi, , Japan
Tokorozawa Heart Center
Tokorozawa-shi, Saitama, , Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, , Japan
Juntendo University Hospital_Tokyo
Tokyo, , Japan
Juntendo University Hospital
Tokyo, , Japan
Sugawara Clinic
Tokyo, , Japan
Minamino Cardiovascular Hospital_Cardiovascular medicine
Tokyo, , Japan
Minamino Cardiovascular Hospital
Tokyo, , Japan
Tokyo Nishi Tokushukai Hospital_Cardiovascular medicine
Tokyo, , Japan
Tokyo Nishi Tokushukai Hospital
Tokyo, , Japan
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia
Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan
Kota Bharu, Kelantan, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Putrajaya
Putrajaya, Putrajaya, Malaysia
Sarawak Heart Centre
Kota Samarahan, Sarawak, Malaysia
Hospital Miri
Miri, Sarawak, Malaysia
University Technology MARA (UiTM) - Puncak Alam
Sungai Buloh, Selangor, Malaysia
University Technology MARA (UiTM) - Sg Buloh
Sungai Buloh, Selangor, Malaysia
Hospital Sultanah Bahiyah
Alor Star, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Hospital Miri
Sarawak, , Malaysia
Hospital Tuanku Jaafar
Seremban, , Malaysia
Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC
Guadalajara, Jalisco, Mexico
Consultorio Arechavaleta Granell María del Rosario
Guadalajara, Jalisco, Mexico
Centro de Atención Integral al Paciente con Diabetes
Tlalpan, México, D.F., Mexico
Internal Medicine Clin Trials
Monterrey, Nuevo León, Mexico
Cardiolink Clin Trials S.C.
Monterrey, Nuevo León, Mexico
Unidad Medica para la Salud Integral (UMSI)
San Nicolás de los Garza, Nuevo León, Mexico
Investigación Médica Sonora S.C.
Hermosillo, Sonora, Mexico
EME Red Hospitalaria
Mérida, Yucatán, Mexico
Medical Care and Research S. A de C.V
Mérida, Yucatán, Mexico
Centro de Investigación Cardiometabólica de Aguascalientes
Aguascalientes, , Mexico
Meander Medisch Centrum
Amersfoort, , Netherlands
Amsterdam UMC Lokatie VUMC
Amsterdam, , Netherlands
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Bethesda Diabetes Research Center en Bethesda ziekenhuis
Hoogeveen, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Clinic of Diabetes Cluj
Cluj-Napoca, Cluj, Romania
Spitalul Judetean de Urgenta Targoviste
Târgovişte, Dâmbovița County, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, Mureș County, Romania
Sc Mediab Srl
Târgu Mureş, Mureș County, Romania
Novus Medical Clinica SRL
Ploieşti, Prahova, Romania
CMI Dr. Busegeanu Mihaela Magdalena
Ploieşti, Prahova, Romania
CMI Dr. Pletea Noemi SRL
Bacau, , Romania
Diabet Med SRL
Bucharest, , Romania
Clinical Emergency Sf. Apostol Andrei Hospital
Galati, , Romania
Spitalul Clinic Judetean de Urgente Sf. Spiridon
Iași, , Romania
SC Gensan SRL, Policlinica ASTRA
Sibiu, , Romania
Tumen State Medical University
Tyumen, Russia, Russia
City Hospital #5
Barnaul, , Russia
Kazan Federal University
Kazan', , Russia
LLC "Clinic of Aesthetic Medicine & Laser Technologies"
Kazan', , Russia
SAHI Kuzbass Hospital(former Regional clinical hospital)
Kemerovo, , Russia
Friendship University of Russia
Moscow, , Russia
Setchenov First Moscow State Medical University
Moscow, , Russia
State Novosibirsk regional clinical hospital
Novosibirsk, , Russia
Limited Law Company "Healthy Family" Medicine Center"
Novosibirsk, , Russia
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza, , Russia
SPb SBHI City Outpatient clinic #37
Saint Petersburg, , Russia
Aurora MedFort LLC
Saint Petersburg, , Russia
City Consultative & Diagnostic Centre #1
Saint Petersburg, , Russia
SPb SBHI City Multifield Hospital #2
Saint Petersburg, , Russia
Consultative & Diagnostic Center with a Outpatient Hospital
Saint Petersburg, , Russia
Regional clinical cardiology dispensary
Saratov, , Russia
Saratov regional clinical hospital
Saratov, , Russia
Siberian State Medical University
Tomsk, , Russia
Ulianovsk Regional Clinical Hospital
Ulyanovsk, , Russia
Yaroslavl Regional Hospital
Yaroslavl, , Russia
Polyclinic #2 in Yoshkar-Ola
Yoshkar-Ola, , Russia
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, Serbia
CHC Zvezdara, Clinical department for endocrinology
Belgrade, , Serbia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
Kragujevac, , Serbia
Clinical Centre Nis, Endocrinology, Diabetes and Metabolism
Niš, , Serbia
Policlinic for diabetes
Zaječar, , Serbia
Metabolicke Centrum MUDr. Katariny Raslovej s.r.o.
Bratislava, , Slovakia
MediTask, s.r.o
Bratislava, , Slovakia
Nemocnica akademika L. Derera, UNB
Bratislava, , Slovakia
HUMAN-CARE, s.r.o.
Košice, , Slovakia
CARDIO D&R, s.r.o.
Košice, , Slovakia
Nemocnica Krompachy spol. s r.o Diabetol. amb. MD Gmitrov
Krompachy, , Slovakia
Diabetologicka ambulancia MUDr. Katarina Plevova, s.r.o.
Nitra, , Slovakia
DENTAVIA s.r.o.
Poprad, , Slovakia
MUDr. Jan Culak, s.r.o.
Prievidza, , Slovakia
Kardiologicka a interna ambulancia
Rimavská Sobota, , Slovakia
Tatratrial s.r.o.
Rožňava, , Slovakia
IRIDIA s.r.o.
Vrútky, , Slovakia
Diabetes Care Centre & CDE Centre
Benoni, Gauteng, South Africa
Peermed Clinical Trial Centre
Johannesburg, Gauteng, South Africa
Soweto Clinical Trial Centre
Johannesburg, Gauteng, South Africa
Deepak Lakha
Johannesburg, Gauteng, South Africa
Hemant Makan
Johannesburg, Gauteng, South Africa
Deepak Lakha
Johannesburg, Gauteng, South Africa
Centre for Diabetes
Johannesburg, Gauteng, South Africa
Dr Seeber
Pretoria, Gauteng, South Africa
Prof P. Joshi
Pretoria, Gauteng, South Africa
Dr H Bacus
Berea, KwaZulu-Natal, South Africa
Dr A Amod
Durban, KwaZulu-Natal, South Africa
Dr T Padayachee
Durban, KwaZulu-Natal, South Africa
Dr Pillay's Rooms
Durban, KwaZulu-Natal, South Africa
Diabetes Clinical Trials Unit
Cape Town, Western Cape, South Africa
UCT Clinical Research Centre
Cape Town, Western Cape, South Africa
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Hanyang University GURI Hospital
Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, , South Korea
Hospital Fundación Alcorcón
Alcorcón, Madrid, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Comarcal de Antequera
Antequera, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Público da Mariña
Burela de Cabo, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital Univ. de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Ribera Polusa
Lugo, , Spain
Hospital Clinico Virgen de la Victoria
Málaga, , Spain
Hospital Quirón
Pozuelo de Alarcón, , Spain
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, , Spain
Hospital Virgen del Camino - Sanlúcar de Barrameda
Sanlúcar de Barrameda, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Virgen de la Macarena
Seville, , Spain
Changhua Christian Hospital_Metabolic Dept.
Changhua, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan District, , Taiwan
Songklanagarind Hospital
Songkhla, Had-Yai, Thailand
Maharaj Nakorn Chiang Mai Hospital_Endocrilogy
Chiang Mai, Mueang Chiang Mai, Thailand
King Chulalongkorn Memorial Hospital_Endocrinology
Bangkok, , Thailand
Police General Hospital
Bangkok, , Thailand
Phramongkutklao Hospital
Bangkok, , Thailand
Rajavithi Hospital_Diabetes and Endocrinology
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Ramathibodi Hospital-Cardiovascular metabolic Center
Bangkok, , Thailand
SI-Dvs of Endocrinology
Bangkok, , Thailand
Siriraj Hospital-Cardio
Bangkok, , Thailand
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, , Thailand
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
Adana, , Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Kardiyoloji
Bursa, , Turkey (Türkiye)
T.C. Saglik Bakanligi Bursa Il Saglik Mudurlugu Yuksek Ihtıs
Bursa, , Turkey (Türkiye)
Atatürk Üniversitesi Araştırma Hastanesi- Endokrinoloji
Erzurum, , Turkey (Türkiye)
Eskişehir Osmangazi Üniversitesi Sağlık, Uygulama ve Araştırma Hastanesi
Eskişehir, , Turkey (Türkiye)
Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
Hatay, , Turkey (Türkiye)
Haseki Egitim ve Arastirma Hastanesi_ISTANBUL
Istanbul, , Turkey (Türkiye)
Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, , Turkey (Türkiye)
Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-Endokrinoloji
Izmir, , Turkey (Türkiye)
Erciyes Üniversitesi Hastanesi- Nefroloji
Kayseri, , Turkey (Türkiye)
Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
Sivas, , Turkey (Türkiye)
Karadeniz University School of Medicine-Adult Endocrinology
Trabzon, , Turkey (Türkiye)
Adana Şehir Eğitim ve Araştırma Hastanesi
Yüreğir/Adana, , Turkey (Türkiye)
Cherkasy Regional Clinical Hospital - Endocrinology department
Cherkasy, , Ukraine
Chernivtsi Regional Clinical Hospital - Endo Outpatient department
Chernivtsi, , Ukraine
Dnipropetrovsk Regional Clinical Hospital named after І.І.Mechnikov - Endocrinology therapy department
Dnipro, , Ukraine
Kyiv Railway Clinical Hospital #2 - day care department
Kyiv, , Ukraine
Centre of Innovative Medical Technologies of NASU - Therapeutic and Endocrinology Department
Kyiv, , Ukraine
Lviv Regional Clinical Diagnostic and Treatment Endocrinology Centre - Outpatient department
Lviv, , Ukraine
Odesa Regional Clinical Hospital - Endocrinology department
Odesa, , Ukraine
City Clinical Hospital #1 (Poltava) - Therapeutic department
Poltava, , Ukraine
Transcarpathian Regional Clinical Hospital named after A.Novak - Endocrinology department
Uzhhorod, , Ukraine
Zhytomir Regional Clinical Hospital - Endocrinology department
Zhytomyr, , Ukraine
Crouch Oak Family Practice
Addlestone, Surrey, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Royal Victoria Hospital
Belfast, , United Kingdom
The Health Centre
Bradford-on-Avon, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Addenbrooke's Hospital_Cambridge
Cambridge, , United Kingdom
Hathaway Surgery
Chippenham, , United Kingdom
WISDEM Centre
Coventry, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Harrogate District Hospital
Harrogate, , United Kingdom
Burbage Surgery
Hinckley, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Royal Free - Diabetes
London, , United Kingdom
North Manchester General Hospital - Diabetes Centre
Manchester, , United Kingdom
Norfolk and Norwich University Hospital
Norfolk, , United Kingdom
University Dept of Medicine, Derriford Hospital, Plymouth
Plymouth, , United Kingdom
East Surrey Hospital
Redhill, , United Kingdom
The Staploe Medical Centre
Soham, , United Kingdom
Joint Clinical Research Facility - Swansea
Swansea, , United Kingdom
Countries
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References
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Borlaug BA, Holse C, Jung MH, Lincoff AM, Mulvagh SL, Staerk-Ostergaard J, Tuttle KR, Petrie MC. Prevalence and Associations of Systemic Inflammation in Heart Failure Across the Spectrum of Ejection Fraction. JACC Heart Fail. 2025 Oct 15:102712. doi: 10.1016/j.jchf.2025.102712. Online ahead of print.
McGuire DK, Marx N, Mulvagh SL, Deanfield JE, Inzucchi SE, Pop-Busui R, Mann JFE, Emerson SS, Poulter NR, Engelmann MDM, Ripa MS, Hovingh GK, Brown-Frandsen K, Bain SC, Cavender MA, Gislum M, David JP, Buse JB; SOUL Study Group. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. N Engl J Med. 2025 May 29;392(20):2001-2012. doi: 10.1056/NEJMoa2501006. Epub 2025 Mar 29.
Marx N, Deanfield JE, Mann JFE, Arechavaleta R, Bain SC, Bajaj HS, Bayer Tanggaard K, Birkenfeld AL, Buse JB, Davicevic-Elez Z, Desouza C, Emerson SS, Engelmann MDM, Hovingh GK, Inzucchi SE, Jhund PS, Mulvagh SL, Pop-Busui R, Poulter NR, Rasmussen S, Tu ST, McGuire DK; SOUL Study Group. Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial. Circulation. 2025 Jun 10;151(23):1639-1650. doi: 10.1161/CIRCULATIONAHA.125.074545. Epub 2025 Mar 29.
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003141-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1218-5368
Identifier Type: OTHER
Identifier Source: secondary_id
EX9924-4473
Identifier Type: -
Identifier Source: org_study_id
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