Clinical Trials Logo

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
First received
Last updated
Start date March 1, 2023
Est. completion date October 13, 2027

Study information

Verified date June 2024
Source Novo Nordisk A/S
Contact Novo Nordisk
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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 Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli Buenos Aires
Argentina CEMEDIC Caba Buenos Aires
Argentina Centro de Investigación y Prevención Cardiovascular Caba
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 Paratus Clinical Kanwal New South Wales
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 i9 Pesquisas Clínicas Campinas Sao Paulo
Brazil Instituto de Pesquisa Clínica de Campinas 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 ET "Individual practice for specialized outpatient medical care - Dr. Georgi Marinov" Burgas
Bulgaria Medical Centre Diamedical-2013 Dimitrovgrad
Bulgaria Medical centre Asclepius Dupnitsa Kyustendil
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 OCSOMCE - Dr. Albena Dinkova EOOD 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 Kolding Sygehus Karkirurgi Kolding
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 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 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 Connolly 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 Advanced Healthcare 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 Gabinet Leczenia Otylosci i Chorob Dietozaleznych Bialystok Podlaskie Voivodeship
Poland Kresmed Sp. z o. o. Bialystok Podlaskie
Poland Osteo-Medic s.c. A. Racewicz, J. Supronik Bialystok
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 Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz
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 Kliniczno Badawcze Elblag
Poland UCK Klinika Nadcisnienia Tetniczego i Diabetologii Gdansk
Poland Centrum Medyczne Pratia Gdynia Gdynia Pomorskie
Poland Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski Gorzow Wielkopolski Lubuskie
Poland Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski Gorzow Wielkopolski
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 Velocity Nova Sp. z o.o. Lublin Lublin Voivodeship
Poland Zanamed Medical Clinic Sp. z o.o. Lublin
Poland Provita Centrum Medyczne Sp. z o.o. Piotrkow Trybunalski
Poland Provita Centrum Medyczne Sp. z o.o. Piotrkow Trybunalski
Poland ETG Poniatowa Poniatowa Lublin Province
Poland Centrum Zdrowia Metabolicznego Poznan Wielkopolskie Voivodeship
Poland Gaja Poradnie Lekarskie Poznan
Poland Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j. Ruda Slaska
Poland Velocity Nova Sp. z o.o. Staszow
Poland Polsko - Amerykanskie Kliniki Serca X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach Tychy
Poland ETG Warszawa Warsaw Masovian
Poland MEDI CLINICAL Badania Kliniczne Warsaw Masovian Province
Poland Provita Poliklinika Sp. z o.o Warsaw Masovian Province
Poland Provita Poliklinika Sp. z o.o Warsaw Masovian Province
Poland BodyClinic Warszawa
Poland NASMED 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 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Wroclaw Dolnoslaskie
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 Velocity Zamosc 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 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 Dr Pillay's Rooms 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 de la Ribera Alzira Valencia
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 Siriraj Hospital Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital Chiang Mai
Thailand Research Institute for Health Sciences, CMU Chiang Mai
Thailand Srinagarind Hospital Khon Kaen
Thailand Thammasat University Hospital Klong Luang, Pathumthani Pathumthani
Thailand Chiang Rai Prachanukroh Hospital Muang
Thailand Maharat Nakhon Ratchasima Hospital Mueang Nakhon Ratchasima Nakhon Ratchasima
Thailand Ramathibodi Hospital Rajataewe Bangkok
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 University Dept of Medicine, Derriford Hospital, Plymouth Plymouth
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 Royal Cornwall Hospital (Treliske) Truro
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 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 Fleming Island Center for Clinical Research Fleming Island Florida
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 Prem Internal Med Asso Houston Katy Texas
United States Scripps Wht Diab Inst La Jolla La Jolla California
United States Radiance Clinical Research Lampasas Texas
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 Floridian Clinical Research, LLC Miami Lakes Florida
United States San Marcus Res Clin Miami Lakes Miami Lakes 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 Adult Medicine of Lake County, Inc. Mount Dora Florida
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 Capital Area Research LLC Newport Pennsylvania
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
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Completed NCT02502812 - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects Phase 1
Recruiting NCT04216342 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers Phase 1
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT03646656 - Heart Health Buddies: Peer Support to Decrease CVD Risk N/A
Completed NCT02081066 - Identification of CETP as a Marker of Atherosclerosis N/A
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Recruiting NCT03095261 - Incentives in Cardiac Rehabilitation N/A
Completed NCT02868710 - Individual Variability to Aerobic Exercise Training N/A
Completed NCT02589769 - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons N/A
Completed NCT02711878 - Healing Hearts and Mending Minds in Older Adults Living With HIV N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Recruiting NCT02885792 - Coronary Artery Disease in Patients Suffering From Schizophrenia N/A
Completed NCT02272946 - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk Phase 2
Completed NCT02657382 - Mental Stress Ischemia: Biofeedback Study N/A
Completed NCT02640859 - Investigation of Metabolic Risk in Korean Adults
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment