REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

Cardiovascular Disease Clinical Trial

— REDEFINE 3  

Official title:

The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669755
• Other study ID #: NN9838-4942
• Secondary ID: U1111-1270-09432
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2023
• Est. completion date: October 13, 2027

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: October 13, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Male or female
• Age above or equal to 55 years at the time of signing informed consent
• Body mass index (BMI) greater than or equal to (>=) 25.0 kilograms per meter square (kg/m^2)
• Established CVD as evidenced by at least one of the following:

1. Prior myocardial infarction

2. Prior stroke (ischemic or haemorrhagic stroke)

3. Symptomatic peripheral arterial disease (PAD) defined as at least one of the

following:

1. Intermittent claudication with an ankle-brachial index (ABI) less than (<) 0.85 at rest

2. Intermittent claudication with a >= 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computed tomography (CT) angiography or Doppler ultrasound

3. Prior revascularization procedure of a lower extremity peripheral artery

4. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)

For participants with T2D at screening the following inclusion criteria also apply:

• Diagnosed with type 2 diabetes mellitus (T2D) >= 180 days before screening
• HbA1c 6.5%-10% (48-86 millimoles per mole [mmol/mol]) (both inclusive), as measured by central laboratory at screening
• Treatment with either:

1. Lifestyle intervention alone

2. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, a-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label

3. Basal insulin alone or in combination with up to two marketed OADs, all according to local label

Exclusion Criteria:

• Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
• Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
• Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or a medication with GLP-1 activity within 90 days before screening
• End stage renal disease defined as estimated glomerular filtration rate (eGFR) < 15 millileters per minutes per 1.73^2 (mL/min/1.73 m^2), as measured by the central laboratory at screening
• Chronic or intermittent haemodialysis or peritoneal dialysis

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Cagrilintide
Participants will receive 2.4 mg cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
• Semaglutide
Participants will receive 2.4 mg semaglutide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
• Placebo
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.

Locations

Country	Name	City	State
Argentina	Mautalen Salud e investigación	Caba	Buenos Aires
Argentina	Medical Center of Diabetes and Nutrition	Caba
Argentina	Centro de Investigaciones Metabólicas	Capital Federal
Argentina	Centro Médico Privado San Vicente Diabetes	Córdoba
Argentina	Instituto Médico DAMIC	Córdoba
Argentina	Hospital Italiano de la Plata	La Plata	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas	Mar del Plata
Argentina	Consultorio Integral de Atención al Diabético	Morón
Argentina	Instituto Medico Catamarca	Rosario	Santa Fe
Argentina	Instituto de Investigaciones Clinicas San Nicolás	San Nicolás
Argentina	Sanatorio Norte	Santiago del Estero
Australia	Nightingale Research	Adelaide	South Australia
Australia	Royal Adelaide Hospital Cardiovascular Clinical Trials	Adelaide	South Australia
Australia	GenesisCare	Auchenflower	Queensland
Australia	Gosford Renal Research	Gosford	New South Wales
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	HeartCare WA (Joondalup)	Joondalup	Western Australia
Australia	Southern Neurology	Kogarah	New South Wales
Australia	HeartCare SA	Leabrook	South Australia
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Macquarie University	Macquarie Park	New South Wales
Australia	Logan Hospital	Meadowbrook	Queensland
Australia	Baker IDI Heart and Diabetes Institute	Melbourne	Victoria
Australia	One Clinical Research	Nedlands	Western Australia
Australia	Clinitrials	Perth	Western Australia
Brazil	Instituto de Pesquisa Clínica de Campinas	Campinas	Sao Paulo
Brazil	Loema Med e Bem Estar Centro Especializado em Cardiologia	Campinas	Sao Paulo
Brazil	PUCCAMP - Hospital e Maternidade Celso Pierro	Campinas	Sao Paulo
Brazil	Núcleo de Pesquisa Clínica S/S	Curitiba	Parana
Brazil	Centro de Pesquisa em Diabetes Doenças Endócrino-Metabólicas	Fortaleza	CE
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital São Lucas Copacabana	Rio de Janeiro	RJ
Brazil	CIP Centro Integrado de Pesquisas do Hospital de Base	São José do Rio Preto	Sao Paulo
Brazil	Instituto São José dos Campos em Pesquisas Médicas	São José dos Campos	Sao Paulo
Brazil	CEPIC - Centro Paulista de Investigacao Clinica	Sao Paulo
Brazil	CPCLIN - Centro de Pesquisas Clínicas	São Paulo	Sao Paulo
Brazil	CPQuali Pesquisa Clínica Ltda	São Paulo	Sao Paulo
Brazil	Instituto de Pesquisa Clinica (IPEC)	São Paulo	Sao Paulo
Brazil	Centro de Diag. e Pesquisa da Osteoporose do Espírito Santo	Vitória	Espirito Santo
Bulgaria	Specialized Rehabilitation Hospital Zdrave EAD	Bankya
Bulgaria	Diagnostic Consultative Centre 1 Bourgas	Burgas
Bulgaria	Medical Centre Diamedical-2013	Dimitrovgrad
Bulgaria	"Ambulatory for individual practice for specialized medical care - DiMed" EOOD	Haskovo
Bulgaria	Medical centre "Zdrave 1" OOD	Kozloduy
Bulgaria	"MHAT - UniHospital" OOD	Panagyurishte
Bulgaria	"MHAT - Pazardzhik"	Pazardzhik
Bulgaria	"Medical center Medconsult Pleven" OOD	Pleven
Bulgaria	"UMHAT Plovdiv" AD	Plovdiv
Bulgaria	'MHAT Sveta Karidad' EAD	Plovdiv
Bulgaria	Diagnostic Consulting Center Pulmed EOOD	Plovdiv
Bulgaria	MHAT "Med Line Clinic"	Plovdiv
Bulgaria	UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases	Plovdiv
Bulgaria	UMHAT Pulmed, Endocrinology and Metabolic Diseases	Plovdiv
Bulgaria	MHAT Medica - Ruse OOD	Ruse
Bulgaria	''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood	Samokov
Bulgaria	MHAT "Dr. Ivan Seliminski"-Sliven	Sliven
Bulgaria	"Nader Yabrudi - ASMPVBE Individual practice"	Smolyan
Bulgaria	"Medical Center Diamedical - 2013" OOD - Sofia	Sofia
Bulgaria	Acibadem City Clinic MHAT Tokuda Department of Endocrinology	Sofia
Bulgaria	Medical centre Vitclinic EOOD	Sofia
Bulgaria	Medical Institute of Ministry of interior	Sofia
Bulgaria	MHAT "Knyaginya Klementina" -Sofia EAD	Sofia
Bulgaria	MHAT 'Sveta Sofia' EOOD	Sofia
Bulgaria	Orthopaedic Center Kinov	Sofia
Bulgaria	UMHAT "Sveti Ivan Rilski"	Sofia
Bulgaria	UMHAT Aleksandrovska	Sofia
Bulgaria	"Medical center Zara-Med" EOOD	Stara Zagora
Bulgaria	"Prevencia-2000-MCOC"	Stara Zagora
Bulgaria	"UMHAT- Prof. dr. Stoyan Kirkovich"	Stara Zagora
Bulgaria	MBAL Trakia EOOD	Stara Zagora
Bulgaria	Medical Center "Nov Rehabilitatsionen center" EOOD	Stara Zagora
Bulgaria	UMHAT Sveta Marina EAD	Varna
Bulgaria	Diagnostic Consulting Center 1 Velingrad EOOD	Velingrad
Bulgaria	"MHAT "Sveti Panteleimon" - Yambol" AD	Yambol
Bulgaria	Medical centre Runkovi OOD	Yambol
Canada	Centricity Res. Barrie Endo	Barrie	Ontario
Canada	Centricity Research Brampton	Brampton	Ontario
Canada	Viacar Recherche Clinique Inc.	Brossard	Quebec
Canada	C-endo Diab Endo Clin Calgery	Calgary	Alberta
Canada	Centricity Research Calgary	Calgary	Alberta
Canada	Cambridge Cardiac Care Centre	Cambridge	Ontario
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Hamilton Med Res Group	Hamilton	Ontario
Canada	Ctr de rech Clin de Laval	Laval	Quebec
Canada	Manna Research Mirabel	Mirabel	Quebec
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Applied Medical Informatics Research	Montreal	Quebec
Canada	Kawartha Cardiology Clinical Trials	Peterborough	Ontario
Canada	Diex Recherche Quebec Inc.	Quebec
Canada	Institut universitaire de cardiologie	Quebec
Canada	Recherche Clinique Sigma Inc.	Quebec
Canada	Clin des Mal Lipid de Quebec	Québec	Quebec
Canada	CHU-Sherbrooke	Sherbrooke	Quebec
Canada	Ctr de méd métab de Lanaudière	Terrebonne	Quebec
Canada	Diabetes Heart Research Centre	Toronto	Ontario
Canada	Clinical Research Solutions Inc.	Waterloo	Ontario
Colombia	Clinica de la Costa	Barranquilla
Colombia	Fundacion del Caribe para la Investigacion Biomedica-BIOS	Barranquilla
Colombia	CentrodeInvestigaciónenReumatologíayEspecialidadesMédicas	Bogota
Colombia	Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia	Bucaramanga-piedecuesta, Valle Del Menzuli - Santander	Santander
Colombia	FOSCAL	Floridablanca	Santander
Colombia	Somer Sociedad Medica Rionegro S.A. Somer S.A.	Rionegro
Colombia	Fundación Hospital Universidad del Norte	Soledad	Barranquilla
Denmark	Aarhus Universitetshospital, Skejby Hjertesygdomme	Aarhus N	Region Midtjylland
Denmark	Aarhus Universitetshospital, Steno Diabetes Center Aarhus	Aarhus N
Denmark	Herlev og Gentofte Hospital	Hellerup	Region Hovedstaden
Denmark	Regionshospitalet Gødstrup, Hjertesygdomme	Herning
Denmark	Hillerød Endokrinologisk amb. H0652	Hillerød
Denmark	Holbæk Sygehus	Holbæk	Region Sjælland
Denmark	Slagelse Sygehus Ambulatorium for hjertesygdomme	Slagelse
Denmark	Slagelse Sygehus Ambulatorium for hjertesygdomme	Slagelse
Denmark	Kardiologisk Odense & Svendborg	Svendborg	Region South
Denmark	Viborg Sygehus	Viborg
France	Centre Hospitalier d'Annonay	Annonay
France	Centre Hospitalier Ardeche Nord	Annonay cedex
France	Ap-Hp-Hopital Avicenne	Bobigny
France	Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2	Grenoble cedex 9
France	CH Louis Pasteur	Le Coudray
France	Les Hopitaux de Chartres-Hopital Louis Pasteur	Le Coudray
France	Groupe Hospitalier Du Havre	Le Havre
France	Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez	Lille
France	Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie	Montpellier
France	Aphp-Hopital La Pitie Salpetriere-2	Paris
France	Hopital Novo	Pontoise
France	Centre Hospitalier Bretagne Atlantique	Vannes
France	Groupe Hospitalier Mutualiste Des Portes Du Sud	Venissieux
France	RESEAU DE SANTE MUTUALISTE-Médipôle Hôpital Mutualiste	Villeurbanne
Germany	Diabeteszentrum-Do Dres. K U. Ch. Busch GbR	Dortmund
Germany	Medizinische Klinik III Studienzentrum für Stoffwechselerkrankungen der TU Dresden	Dresden
Germany	Zentrum fuer klinische Studien Suedbrandenburg GmbH	Elsterwerda
Germany	InnoDiab Forschung GmbH	Essen
Germany	MVZ CCB Frankfurt Und Main-Taunus GbR	Frankfurt
Germany	Diabetes-Zentrum Wilhelmsburg	Hamburg
Germany	Diabetes-Zentrum-Wilhelmsburg GbR	Hamburg
Germany	Wendisch/Dahl Hamburg	Hamburg
Germany	Uniklinik Heidelberg Innere Medizin I	Heidelberg
Germany	AmBeNet GmbH	Leipzig
Germany	University of Leipzig	Leipzig
Germany	Diabeteszentrum Ludwigsburg	Ludwigsburg
Germany	Institut für Diabetesforschung GmbH Münster - Dr. med. Rose	Münster
Germany	Institut für Diabetesforschung GmbH Münster - Dr. med. Rose	Münster
Germany	Uniklinik Münster, Klinik für Kardiologie I	Münster
Germany	Uniklinik Münster, Klinik für Kardiologie I	Münster
Germany	RED-Institut für medizinische Forschung und Fortbildung GmbH	Oldenburg in Holstein
Germany	Zentrum für klinische Studien Alexander Segner	Saint Ingbert-Oberwürzbach
Germany	Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann	Witten
India	CIMS- Care Institute of Medical Sciences	Ahmedabad	Gujarat
India	CIMS- Care Institute of Medical Sciences	Ahmedabad	Gujarat
India	Jawahar Lal Nehru Govt. Medical College	Ajmer	Rajasthan
India	Jawahar Lal Nehru Govt. Medical College	Ajmer	Rajasthan
India	J N Medical College	Aligarh
India	All India Institute of Medical Sciences_Delhi	Ansari Nagar	New Delhi
India	All India Institute of Medical Sciences_Delhi	Ansari Nagar	New Delhi
India	Kamalnayan Bajaj Hospital	Aurangabad	Maharashtra
India	Kamalnayan Bajaj Hospital	Aurangabad	Maharashtra
India	Lifecare Hospital and Research Centre	Bangalore	Karnataka
India	Lifecare Hospital and Research Centre	Bangalore	Karnataka
India	Narayana Hrudayalya Institute of Cardiac Sciences	Bangalore
India	Narayana Hrudayalya Institute of Cardiac Sciences	Bangalore
India	Ramaiah Memorial Hospital	Bangalore	Karnataka
India	AMRI Hospital	Bhubaneswar	Orissa
India	SP Medical College	Bikaner	Rajasthan
India	Madras Diabetes Research Foundation	Chennai	Tamil Nadu
India	Kg Hospital and Post Graduate Medical Institute	Coimbatore	Tamil Nadu
India	Kg Hospital and Post Graduate Medical Institute	Coimbatore	Tamil Nadu
India	Shri Mahant Indiresh Hospital	Dehradun	Uttarakhand
India	Shri Mahant Indiresh Hospital	Dehradun	Uttarakhand
India	Apollo Hospital	Delhi	New Delhi
India	Indraprastha Apollo Hospital	Delhi	New Delhi
India	Endolife Specialty Hospitals	Guntur	Andhra Pradesh
India	Lalitha Super Specialities Hospital	Guntur	Andhra Pradesh
India	Excelcare Hospital	Guwahati	Assam
India	Excelcare Hospital	Guwahati	Assam
India	AIG Hospitals,Hyderabad	Hyderabad	Telangana
India	Guru Nanak CARE Hospitals	Hyderabad	Telangana
India	Ramdev Rao Hospital	Hyderabad	Telangana
India	Ramdev Rao Hospital	Hyderabad	Andhra Pradesh
India	Mohak Bariatrics and Robotics	Indore	Madhya Pradesh
India	Mohak Bariatrics and Robotics	Indore	Madhya Pradesh
India	Diabetes, Thyroid and Endocrine Centre	Jaipur	Rajasthan
India	Diabetes, Thyroid and Endocrine Centre	Jaipur	Rajasthan
India	SMS Medical College & Attached Hospitals	Jaipur	Rajasthan
India	All India Institute of Medical Sciences (AIIMS)	Jodhpur	Rajasthan
India	All India Institute of Medical Sciences (AIIMS)	Jodhpur	Rajasthan
India	All India Institute of Medical Sciences (AIIMS)	Jodhpur
India	All India Institute of Medical Sciences_Khurda	Khurda	Orissa
India	Excel Endocrine Centre	Kolhapur	Maharashtra
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	IPGME&R and SSKM Hospital	Kolkata	West Bengal
India	IPGME&R and SSKM Hospital	Kolkata	West Bengal
India	Government Medical College, Kozhikode	Kozhikode	Kerala
India	King George's Medical University	Lucknow	Uttar Pradesh
India	King George's Medical University (KGMU)	Lucknow	Uttar Pradesh
India	Sanjay Gandhi Postgraduate Institute of Medical Science	Lucknow	Uttar Pradesh
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	Christian Medical College and Hospital	Ludhiana	Punjab
India	Christian Medical College and Hospital	Ludhiana	Punjab
India	Omega Hospital (P) Limited	Mangalore	Karnataka
India	Omega Hospital (P) Limited	Mangalore	Karnataka
India	Fortis Heart Institute and Multispeciality Hospital	Mohali	Punjab
India	Fortis Heart Institute and Multispeciality Hospital	Mohali	Punjab
India	Seth GS Medical College & KEM Hospital	Mumbai	Maharashtra
India	Sir H. N. Reliance Foundation Hospital and Research Centre	Mumbai	Maharashtra
India	Wockhardt Hospital, Mumbai Central	Mumbai	Maharashtra
India	Mysore Medical College and Research Institute	Mysore	Karnataka
India	Mysore Medical College and Research Institute	Mysore	Karnataka
India	All India Institute of Medical Sciences (AIIMS), Nagpur	Nagpur	Maharashtra
India	All India Institute of Medical Sciences (AIIMS), Nagpur	Nagpur	Maharashtra
India	Diabetes Care N' Research Centre Pvt. Ltd.	Nagpur
India	Magnum Heart Institute	Nashik
India	Magnum Heart Institute	Nashik
India	BL Kapur Super Specialty Hospital	New Delhi
India	Dr. BL Kapur Memorial Hospital	New Delhi
India	G.B Pant Institute of Post Graduate medical education and research	New Delhi
India	G.B Pant Institute of Post Graduate medical education and research	New Delhi
India	Sir Ganga Ram Hospital	New Delhi
India	Sir Ganga Ram Hospital	New Delhi
India	Sir Ganga Ram Hospital	New Delhi
India	B J Medical College & Sassoon Hospital	Pune
India	Chellaram Diabetes Institute	Pune	Maharashtra
India	Grant Medical Foundation Ruby Hall Clinic	Pune	Maharashtra
India	Nirmal Hospital Pvt. Ltd.	Surat
India	Unicare heart institute and research centre	Surat	Gujarat
India	Unicare heart institute and research centre	Surat	Gujarat
India	Ashirwad Hospital and Research Centre	Thane	Maharashtra
India	Rhythm Heart Institute	Vadodara	Gujarat
India	Rhythm Heart Institute	Vadodara	Gujarat
India	Christian Medical College Hospital, Vellore	Vellore	Tamil Nadu
India	Sunrise Hospital	Vijayawada	Andhra Pradesh
India	Sunrise Hospital	Vijayawada	Andhra Pradesh
Ireland	Clinical Research Centre, St. Vincent's University Hospital,	Dublin	Leinster
Ireland	Mater Miscericordiae Hospital	Dublin	Leinster
Ireland	Mater Miscericordiae Hospital	Dublin	Leinster
Ireland	St James's CRF	Dublin	Leinster
Ireland	CRF - Galway	Galway	Connaght
Ireland	CRF - Galway	Galway	Connaght
Italy	Ente Ecclesiastico Ospedale Generale Regionale Miulli	Acquaviva delle Fonti
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona	Ancona
Italy	A.O.U. Consorziale Policlinico di Bari	Bari	BA
Italy	A.O.U. Policlinico S.Orsola Malpighi	Bologna
Italy	A.O.U policlinico "G. Rodolico-San Marco"	Catania
Italy	Università degli studi G. D'Annunzio Chieti Pescara - CAST	Chieti Scalo
Italy	AOU Careggi Firenze	Firenze
Italy	Ospedale Santa Maria Goretti - UOD Diabetologia	Latina	LT
Italy	Azienda Ospedaliera Luigi Sacco	Milano
Italy	Azienda Ulss 3 Serenissima	Mirano	VE
Italy	Azienda Ospedaliero Universitaria di Modena Ospedale Civile di Baggiovara	Modena
Italy	Azienda Ospedaliera Universitaria Federico II di Napoli	Napoli
Italy	AOUP Giaccone Palermo	Palermo
Italy	Azienda Ospedaliera-Universitaria Parma	Parma
Italy	ICS Maugeri	Pavia	Pv
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Azienda Ospedaliero - Universitaria Sant'Andrea	Roma
Italy	Pol. Uni. Campus Biomedico UOC Endocrinologia e Diabetologia	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	RM
Italy	Centro di Alta Spec. Diet., Educ. Alim. e Prev. Cardio Metab	San Donato Milanese (MI)	MI
Italy	IRCCS Multimedica	Sesto San Giovanni (MI)
Italy	Azienda Ospedaliera Universitaria Senese	Siena	Si
Japan	Akaicho Clinic	Chiba-shi, Chiba
Japan	Mikannohana Clinic, Diabetes, Endocrinology and Metabolism_Diabetes Internal Medicine	Ehime
Japan	Naka Kinen Clinic	Ibaraki
Japan	Seino Internal Medicine Clinic	Koriyama-shi	Fukushima, Japan
Japan	Jinnouchi Hospital	Kumamoto-shi	Kumamoto, Japan
Japan	Tokyo Saiseikai Central Hospital	Minato-ku, Tokyo
Japan	Minami Akatsuka Clinic	Mito-shi, Ibaraki
Japan	Nanbu Tokushukai Hospital_Internal medicine	Okinawa
Japan	AMC NISHI-UMEDA Clinic	Osaka
Japan	Nozaki Tokushukai Hospital	Osaka
Japan	Yao Tokushukai General Hospital	Osaka
Japan	Sakurabashi Watanabe Future Medical Hospital	Osaka-city, Osaka
Japan	Saga University Hospital, Department of Cardiology	Saga
Japan	Kagawa Prefectural Central Hospital, Cardiovascular Medicine	Takamatsu-shi, Kagawa
Japan	Takasaki General Medical Center_Department of Endocrinology / Metabolism Internal Medicine	Takasaki-shi, Gunma
Japan	Fukuwa Clinic	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Japan	Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology	Wakayama
Japan	National Hospital Organization Saitama Hospital	Wako-shi, Saitama
Malaysia	Hospital Pulau Pinang	George Town	Penang
Malaysia	Hospital Serdang	Kajang	Selangor
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Hospital Melaka	Melaka
Malaysia	Hospital Miri	Sarawak
Malaysia	Hospital Seri Manjung	Seri Manjung	Perak
Malaysia	Hospital Shah Alam	Shah Alam
Malaysia	Hospital Sibu	Sibu	Sarawak
Malaysia	Hospital Sultan Haji Ahmad Shah	Temerloh,Pahang
Mexico	Promotora Medica Aguascalientes SA de CV	Aguascalientes
Mexico	Centro de Estudios de Investigación Metabólicos y Cardio	Ciudad Madero	Tamaulipas
Mexico	Instituto de Diabetes Obesidad y Nutricion S.C.	Cuernavaca	Morelos
Mexico	Centro de Investigacion Clinica Endocrinologica de Jalisco	Guadalajara	Jalisco
Mexico	Virgen Cardiovascular Research SC	Guadalajara	Jalisco
Mexico	Clínica García Flores	Monterrey	Nuevo León
Mexico	Internal Medicine Clin Trials	Monterrey	Nuevo León
Mexico	Unidad Biomedica Avanzada Monterrey	Monterrey	Nuevo León
Mexico	Centro de atención e investigación cardiovascular del Potosí	San Luis Potosí	San Luis Potosi
Mexico	Consultorio 1020 Hospital Angeles Xalapa	Xalapa	Veracruz
Netherlands	Gelre Ziekenhuizen Apeldoorn	Apeldoorn
Netherlands	Máxima Medisch Centrum	Eindhoven
Netherlands	Groene Hart Ziekenhuis, locatie Bleuland	Gouda
Netherlands	UMC Groningen	Groningen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Radboudumc	Nijmegen
Netherlands	Franciscus Gasthuis en Vlietland	Rotterdam
Netherlands	D & A Research B.V.	Sneek
Netherlands	Ziekenhuis Rivierenland Tiel	Tiel
Poland	American Heart of Poland S.A.	Belchatow	Lodzkie
Poland	Kresmed Sp. z o. o.	Bialystok	Podlaskie
Poland	Renew Clinic Bialystok	Bialystok
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio	Bialystok	Podlaskie
Poland	American Heart of Poland S.A.	Bielsko-Biala
Poland	Gierach-Med	Bygdoszcz
Poland	Gierach-Med	Bygdoszcz	Kuyavian-Pomeranian Voivodeship
Poland	Pratia S.A.	Chojnice
Poland	Pratia S.A.	Chojnice
Poland	Malopolskie Centrum Sercowo-Naczyniowe	Chrzanow	Malopolskie
Poland	NSZOZ Unica CR	Dabrowka
Poland	NSZOZ Unica CR	Dabrowka	Wielkopolskie
Poland	Centrum Medyczne Pratia Gdynia	Gdynia	Pomorskie
Poland	Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski	Gorzow Wielkopolski
Poland	Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski	Gorzow Wielkopolski	Lubuskie
Poland	CareClinic	Katowice
Poland	Kardio Klinika Brynów	Katowice	Silesia
Poland	M2M Med. Sp. z o.o. Sp. j.	Katowice
Poland	Pro Familia Altera Sp. z o.o.	Katowice	Slaskie
Poland	Uniwersyteckie Centrum Kliniczne SUM w Katowicach	Katowice
Poland	Grazyna Pulka Specjalistyczny Osrodek "All-Med"	Krakow
Poland	Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET	Krakow	Malopolskie
Poland	Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lodz
Poland	Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lodz
Poland	Gabinet Lekarski Malgorzata Saryusz-Wolska	Lodz
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika	Lodz	Lodzkie
Poland	Zanamed Medical Clinic Sp. z o.o.	Lublin
Poland	Provita Centrum Medyczne Sp. z o.o.	Piotrkow Trybunalski
Poland	ETG Poniatowa	Poniatowa	Lublin Province
Poland	Centrum Zdrowia Metabolicznego	Poznan	Wielkopolskie Voivodeship
Poland	Ko-Med Nova Sp.zo.o. STASZOW	Staszow
Poland	Polsko - Amerykanskie Kliniki Serca X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach	Tychy
Poland	MEDI CLINICAL Badania Kliniczne	Warsaw	Masovian Province
Poland	Provita Poliklinika Sp. z o.o	Warsaw	Masovian Province
Poland	BodyClinic	Warszawa
Poland	NASMED	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego Centrum Medycznego Ksztalcenia Podyplomowego	Warszawa	Mazowieckie
Poland	Szpital Czerniakowski Sp. z o.o.	Warszawa
Poland	Pracownia Badan Klinicznych SALUS	Wroclaw
Poland	Pracownia Badan Klinicznych SALUS	Wroclaw
Poland	Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga, Stasinska Spólka Partnerska Lekarzy	Wroclaw	Lower Silesian Province
Poland	Slaskie Centrum Chorob Serca W Zabrzu	Zabrze	Slaskie
Poland	Slaskie Centrum Chorob Serca W Zabrzu	Zabrze	Slaskie
Poland	Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu	Zabrze
Poland	Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu	Zabrze	Slaskie
Poland	Ko-Med Nova Sp.zo.o. oddzial w Zamosciu	Zamosc
Poland	Prywatna Praktyka Lekarska Anna Chudoba	Zyrardów	Masovian
Serbia	CHC Zvezdara, Clinical department for endocrinology	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Endocrinology, Diabetes and Metabolism Diseases Clinic	Belgrade
Serbia	Endocrinology, Diabetes and Metabolism Diseases Clinic	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department	Kragujevac
Serbia	Clinical Centre Nis, Endocrinology, Diabetes and Metabolism	Nis	RS
Serbia	University Clinical Centre Nis	Nis	RS
Serbia	Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.	Novi Sad	Vojvodina
Serbia	Policlinic for diabetes	Zajecar
South Africa	Cardiac Clinical Research Unit, University of Cape Town	Cape Town	Western Cape
South Africa	Prof Rayner	Cape Town	Western Cape
South Africa	Tread Research (Pty)Ltd	Cape Town	Western Cape
South Africa	Dr A Amod	Durban	KwaZulu-Natal
South Africa	Maxwell Centre	Durban	KwaZulu-Natal
South Africa	Netcare Umhlanga Medical Centre	Durban	KwaZulu-Natal
South Africa	Ezintsha Research Centre	Johannesburg	Gauteng
South Africa	Hemant Makan	Johannesburg	Gauteng
South Africa	Soweto Clinical Trial Centre	Johannesburg	Gauteng
South Africa	Dr Hendrik Snyman's Practice	Mossel Bay	Western Cape
South Africa	Phoenix Pharma	Port Elizabeth	Eastern Cape
South Africa	Clinical Trial Systems (CTC)	Pretoria	Gauteng
South Africa	Dr Seeber	Pretoria	Gauteng
South Africa	Jongaie Research	Pretoria	Gauteng
South Africa	Prinshof Medical Campus	Pretoria	Gauteng
South Africa	Prof P. Joshi	Pretoria	Gauteng
South Africa	Raslouw Private Hospital	Pretoria	Gauteng
South Africa	Clinical Projects Research	Worcester	Western Cape
Spain	Hospital Comarcal de Antequera	Antequera
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Vithas Sevilla	Castilleja Dela Cuesta Sevilla
Spain	Hospital Reina Sofia	Córdoba
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas de Gran Canaria
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Clínico Virgen de la Victoria	Málaga
Spain	Hospital Son Espases	Palma de Mallorca
Spain	Hospital Quirón	Pozuelo de Alarcón
Spain	Hospital Virgen del Camino - Sanlúcar de Barrameda	Sanlúcar de Barrameda
Spain	Clínica Nuevas Tecnologías en Diabetes y Endocrinología	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital General Universitario de Toledo	Toledo
Spain	Hospital General de Valencia	Valencia
Thailand	Cardio-Vajira	Bangkok
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Phramongkutklao Hospital-neuro	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Thailand	Research Institute for Health Sciences, CMU	Chiang Mai
Thailand	Thammasat University Hospital	Klong Luang, Pathumthani	Pathumthani
Thailand	Maharat Nakhon Ratchasima Hospital	Mueang Nakhon Ratchasima	Nakhon Ratchasima
Thailand	Songklanagarind Hospital	Songkla
Turkey	Baskent Universitesi Adana	Adana
Turkey	T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastan	Adana
Turkey	Afyonkarahisar Health Sciences University	Afyon
Turkey	Ankara Sehir Hastanesi Dahiliye Klinigi	Ankara
Turkey	Baskent University Ankara Hospital	Ankara	Bahcelievler
Turkey	Baskent University Ankara Hospital	Ankara	Bahcelievler
Turkey	T.C. Saglik Bakanligi Bursa Il Saglik Mudurlugu Yuksek Ihtis	Bursa	Yildirim
Turkey	Trakya University	Edirne
Turkey	Eskisehir Osmangazi University Saglik Uygulama ve Arastirma	Eskisehir	Odunpazari
Turkey	Eskisehir Sehir Hastanesi	Eskisehir
Turkey	Basaksehir Cam ve Sakura Sehir Hastanesi	Istanbul
Turkey	Istanbul University Cardiology Institute	Istanbul
Turkey	Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Kartal Kosuyolu Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Istanbul	Kartal
Turkey	Marmara University, Endocrinology Department	Istanbul
Turkey	Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi	Istanbul
Turkey	T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul
Turkey	Dokuz Eylul University Medical Faculty	Izmir
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras
Turkey	Erciyes Universitesi Tip Fakultesi	Kayseri
Turkey	Erciyes University Cardiology	Kayseri
Turkey	Kocaeli Universitesi Tip Fakultesi Hastanesi	Kocaeli
Turkey	Kutahya Saglik Bilimleri Universitesi	Kutahya
Turkey	Mersin University Cardiology	Mersin
Turkey	Mersin University Cardiology	Mersin
Turkey	Mersin University Medicine Faculty	Mersin
Turkey	Samsun Ondokuz Mayis Universitesi	Samsun
United Kingdom	Blackpool Victoria Hospital	Blackpool	Lancashire
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	The Health Centre	Bradford-on-Avon
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Countess of Chester Hospital	Chester
United Kingdom	University Hospitals of Coventry and Warwickshire NHS Trust	Coventry
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust	Exeter
United Kingdom	Intelligent Clinical	Glasgow
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	The Diabetes Centre	Ipswich
United Kingdom	St James's University Hospital	Leeds
United Kingdom	Leicester General Hospital	Leicester
United Kingdom	The Good Practice	London
United Kingdom	Patient Recruitment Centre: Newcastle	Newcastle upon Tyne
United Kingdom	East Surrey Hospital	Redhill
United Kingdom	East Surrey Hospital	Redhill
United Kingdom	Clifton Medical Centre	Rotherham
United Kingdom	The Staploe Medical Centre	Soham
United Kingdom	St. Richards Hospital	West Sussex
United States	Albany Medical College	Albany	New York
United States	Renal Medicine Associates	Albuquerque	New Mexico
United States	PharmaTex Research	Amarillo	Texas
United States	Arlington Family Res. Ctr Inc	Arlington	Texas
United States	Northwest Heart Clinical Research, LLC	Arlington Heights	Illinois
United States	Ascension Saint Agnes Heart Ca	Baltimore	Maryland
United States	Heritage Valley Medical Group	Beaver	Pennsylvania
United States	National Heart Institute Cal	Beverly Hills	California
United States	Univ of Alabama Birmingham	Birmingham	Alabama
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Capital Area Cardio Assoc	Camp Hill	Pennsylvania
United States	UNC- Chapel Hill	Chapel Hill	North Carolina
United States	Univ Diab & Endo Consultants	Chattanooga	Tennessee
United States	Innovative Research of W Florida Inc.	Clearwater	Florida
United States	Cleveland Clinic - Main Campus	Cleveland	Ohio
United States	South Texas Clinical Research	Corpus Christi	Texas
United States	West Broadway Clinic	Council Bluffs	Iowa
United States	Valley Clinical Trials	Covina	California
United States	Baylor Scott & White Res Inst	Dallas	Texas
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Providence Health Partners Ctr	Dayton	Ohio
United States	Florida Premier Cardiology	Delray Beach	Florida
United States	Dallas Heart and Vascular	Duncanville	Texas
United States	Duke University	Durham	North Carolina
United States	Academy of Diabetes, Thyroid & Endocrine, P.A.	El Paso	Texas
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Elite Research Center	Flint	Michigan
United States	Diabetes and Thyroid Ctr of FW	Fort Worth	Texas
United States	American Hlth Ntwk of IN LLC	Franklin	Indiana
United States	Macoupin Research Group	Gillespie	Illinois
United States	Clinical Invest Special_Gurnee	Gurnee	Illinois
United States	Louisiana Heart Center	Hammond	Louisiana
United States	PrimeCare Medical Group	Houston	Texas
United States	Southwest Houston Research Ltd	Houston	Texas
United States	Synergy Groups Medical	Houston	Texas
United States	Rocky Mountain Diab&Osteo Ctr	Idaho Falls	Idaho
United States	Rocky Mountain Diab&Osteo Ctr	Idaho Falls	Idaho
United States	Clinical Research Consultants, LLC	Kansas City	Missouri
United States	Scripps Wht Diab Inst La Jolla	La Jolla	California
United States	First Valley Medical Group	Lancaster	California
United States	The Research Group of Lexington LLC	Lexington	Kentucky
United States	Clinical Trials Research_Sacramento	Lincoln	California
United States	Clinical Trials Research_Sacramento	Lincoln	California
United States	Torrance Clin Res Inst, Inc.	Lomita	California
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	Pacific Clinical Studies	Los Alamitos	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	L-MARC Research Center	Louisville	Kentucky
United States	Texas Inst, Kdny & Endo Disor	Lufkin	Texas
United States	Ohio- Advanced Medical Research	Maumee	Ohio
United States	Texas Institute of Cardiology PA	McKinney	Texas
United States	Life Spring Research	Miami	Florida
United States	Oceane 7 Medical & Research Center, Inc.	Miami	Florida
United States	Reyes Clinical Research, Inc	Miami	Florida
United States	Monterey Endocrine & Diabetes Institute, Inc	Monterey	California
United States	Chambliss Clinical Trials LLC	Montgomery	Alabama
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Carolina Health Specialists	Myrtle Beach	South Carolina
United States	Southern New Hampshire Diabetes and Endocrinology	Nashua	New Hampshire
United States	Eastern Nephr Assoc, PLLC	New Bern	North Carolina
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	York Clinical Research LLC	Norfolk	Virginia
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Methodist Physicians Clin	Omaha	Nebraska
United States	Univ of NE Med Center_Omaha	Omaha	Nebraska
United States	VA Neb West Iowa Hlth System	Omaha	Nebraska
United States	Midwest Heart & Vasc Spec	Overland Park	Kansas
United States	Desert Oasis Hlthcr Med Group	Palm Springs	California
United States	Aria Endocrine Metabolic Assoc	Philadelphia	Pennsylvania
United States	Western University of Health Sciences	Pomona	California
United States	Western University of Health Sciences	Pomona	California
United States	Hanson Clinical Research Center	Port Charlotte	Florida
United States	Dominion Medical Associates	Richmond	Virginia
United States	Endo Res Solutions Inc	Roswell	Georgia
United States	Texas Diabetes & Endocrinology_Round Rock	Round Rock	Texas
United States	Northeast Research Institute	Saint Augustine	Florida
United States	Northeast Research Institute	Saint Augustine	Florida
United States	Amicis Centers of Clinical Research	Saint Louis	Missouri
United States	St Louis Heart & Vascular, P.C.	Saint Louis	Missouri
United States	StudyMetrix Research LLC	Saint Peters	Missouri
United States	VA Medical Center_Salem	Salem	Virginia
United States	Audie L. Murphy VA Hospital	San Antonio	Texas
United States	Clinical Advancement Ctr, PLLC	San Antonio	Texas
United States	Northeast Clinical Research of San Antonio	San Antonio	Texas
United States	San Antonio Prem Int Med	San Antonio	Texas
United States	Univ Of Texas Hlth Science Cntr	San Antonio	Texas
United States	Linda Vista Health Care Ctr	San Diego	California
United States	N America Res Inst - San Dimas	San Dimas	California
United States	Saratoga Clinical Research	Saratoga Springs	New York
United States	Honor Health	Scottsdale	Arizona
United States	NorthShore Univ Hlth Sys	Skokie	Illinois
United States	Clinvest Research	Springfield	Missouri
United States	Piedmont Healthcare/Research	Statesville	North Carolina
United States	Simcare Medical Research, LLC	Sugar Land	Texas
United States	Lundquist Inst.-Biom Inno-UCLA	Torrance	California
United States	Arcturus Healthcare, PLC	Troy	Michigan
United States	Hillcrest Family Health Center	Waco	Texas
United States	Aspirus Research Institute	Wausau	Wisconsin
United States	Cardio Partners Clin Res Inst	Wellington	Florida
United States	Confluence Health Hospital	Wenatchee	Washington
United States	Valley Diab. & Endo Comp Ctr	Weslaco	Texas
United States	Iowa Diab & Endo Res Center	West Des Moines	Iowa
United States	Clinical Trials Of America	West Monroe	Louisiana
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Great Lakes Medical Research	Westfield	New York
United States	Selma Medical Associates	Winchester	Virginia
United States	Brookview Hills Research Associates, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Colombia,  Denmark,  France,  Germany,  India,  Ireland,  Italy,  Japan,  Malaysia,  Mexico,  Netherlands,  Poland,  Serbia,  South Africa,  Spain,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke	Measured in days.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Time to occurrence of CV death	Measured in days.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Time to first occurrence of a composite heart failure endpoint consisting of: CV death, heart failure, hospitalisation and urgent heart failure visit	Measured in days.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Time to first occurrence of a composite endpoint: Onset of persistent =40% reduction in eGFRcr (CKD-EPI), Onset of persistent eGFRcr (CKD-EPI) <15 mL/min/1.73 m2, Initiation of chronic kidney replacement therapy, Kidney death and CV death	CKD-EPI is Chronic Kidney Disease Epidemiology Collaboration. Measured in days.	From baseline (week -3) to end of study (up to 242 weeks or more)
Secondary	Time to first occurrence of all-cause death	Measured in days.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Time to first occurrence of an expanded MACE composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation and unstable angina requiring hospitalisation	Measured in days.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction and non-fatal stroke	Measured in days.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Time to first occurrence of myocardial infarction (fatal and non-fatal)	Measured in days.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Time to first occurrence of stroke (fatal and non-fatal)	Measured in days.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to 120 weeks
Secondary	Change in waist circumference	Measured in centimeters (cm).	From baseline (week 0) to 120 weeks
Secondary	Change in systolic blood pressure (SBP)	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to 120 weeks
Secondary	Change in diastolic blood pressure (DBP)	Measured in mmHg.	From baseline (week 0) to 120 weeks
Secondary	Relative change in lipids: Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids	Measured in percentage.	From baseline (week 0) to 120 weeks
Secondary	Change in glycated haemoglobin (HbA1c)	Measured in percentage-points.	From baseline (week 0) to 120 weeks
Secondary	Change in Short Form 36 v2.0 acute (SF-36v2)	SF-36v2.0 is a 36-item commonly used generic clinical outcome assessment (COA) instrument measuring health-related quality of life and general health status across disease areas. The SF-36v2.0 for adults with a 1 week recall period (i.e. acute version) measures the individual overall health-related quality of life in 8 health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role emotional, vitality and mental health). Furthermore, it includes two aggregated scores: a physical component summary score and a mental component summary score. Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state).	From baseline (week 0) to 120 weeks
Secondary	Number of treatment emergent serious adverse events (TESAEs)	Measured in count of events.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Number of event adjudication committee (EAC)-confirmed malignant neoplasms	Measured as count of events.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Number of severe hypoglycaemic episodes (level 3) (only for participants with type 2 diabetes mellitus [T2D] at screening)	Measured as count of events.	From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary	Change from baseline in high-sensitivity C-reactive protein (hsCRP)	Measured in milligram per liter (mg/L)	From baseline (week 0) to 120 weeks
Secondary	Change from baseline in tumour necrosis factor alpha (TNF-a)	Measured in picograms per milliliter (pg/mL)	From baseline (week 0) to 120 weeks
Secondary	Change from baseline in Interleukin 6 (IL-6)	Measured in pg/mL.	From baseline (week 0) to 120 weeks
Secondary	Change from baseline in Interleukin 1 beta (IL-1ß)	Measured in pg/mL.	From baseline (week 0) to 120 weeks
Secondary	Change in pain intensity rated by Numerical Rating Scale (NRS)	The NRS rates average pain intensity in the last 24 hours on a scale from 0 to 10, with 0 meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'.	From baseline (week 0) to 120 weeks
Secondary	Change in Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index is a 19-item, self-rated questionnaire, assessed various aspects of sleep, sleep quality, and sleep disturbances. The PSQI is composed of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score. An overall score ranges from 0 to 21, where lower scores denote a healthier sleep quality.	From baseline (week 0) to 120 weeks
Secondary	Change in neuropathy status by baseline neuropathy group (painful neuropathy, painless neuropathy or no neuropathy)	Measured in percentage.	From baseline (week 0) to 120 weeks