A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified October 2025 by Novo Nordisk A/S
Sponsor
Novo Nordisk A/S
Information Provided by (Responsible Party)
Novo Nordisk A/S
Clinicaltrials.gov Identifier
NCT04560998
Other Study ID Numbers:
NN9535-4533
First Submitted
September 17, 2020
First Posted
September 22, 2020
Results First Posted
June 2, 2025
Last Update Posted
December 11, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on November 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Diabetes Mellitus, Type 2Peripheral Arterial Disease
Drug: SemaglutideDrug: Placebo (semaglutide)

Study Design

Study TypeInterventional
Actual Enrollment792 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEffects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
Study Start DateSeptember 30, 2020
Actual Primary Completion DateJune 4, 2024
Actual Study Completion DateJuly 11, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Semaglutide
Semaglutide given in addition to standard-of-care treatment
Drug: Semaglutide
Semaglutide is administered subcutaneously (s.c.; under the skin) once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.
Placebo (semaglutide)
Placebo given in addition to standard-of-care treatment
Drug: Placebo (semaglutide)
Placebo (semaglutide) is administered s.c. once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.

Outcome Measures

Primary Outcome Measures
  1. Change in Maximum Walking Distance on a Constant Load Treadmill Test
    Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Secondary Outcome Measures
  1. Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test
    Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, which-ever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
  2. Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score
    Change in VascuQoL-6 score is presented. VascuQoL-6 is a peripheral artery disease-specific questionnaire with 6 items covering social, emotional, functional as well as pain- and symptom-related aspects of the patient´s overall quality of life. Each item has a 4-point response scale (where 1 = worst score and 4 = best score). The endpoint analysed is the total score (range: 6-24) generated by summing the scores from all items. A higher score indicates better health status. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
  3. Change in Pain-free Walking Distance on a Constant Load Treadmill Test
    Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stopping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
  4. Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test
    Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stop-ping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
  5. Change in Glycosylated Haemoglobin (HbA1c)
    Change in HbA1c from baseline to week 52 in percentage-point is presented. The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  6. Change in Body Weight
    Change in body weight from baseline to week 52 in kilogram (kg) is presented. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  7. Change in Systolic Blood Pressure
    Change in systolic blood pressure from baseline to week 52 is presented.The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  8. Change in Total Cholesterol
    Change in total cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  9. Change in Low-density Lipoprotein (LDL)-Cholesterol
    Change in LDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  10. Change in High Density Lipoprotein (HDL)-Cholesterol
    Change in HDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  11. Change in Triglycerides
    Change in Triglycerides from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  12. Change in Ankle-Brachial Index (ABI)
    Change in ABI from baseline to week 52 is presented. ABI is calculated as a ratio of the higher ankle systolic pressure to the higher systolic pressure measured in both arms. ABI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. An ABI between 1.0 to 1.4 is considered the normal range. An ABI between 0.90 to 0.99 is considered borderline. An ABI less than 0.90 indicates peripheral artery disease (PAD). The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  13. Change in Toe-Brachial Index (TBI)
    Change in TBI from baseline to week 52 is presented. TBI is calculated as a ratio of the toe systolic pressure to the higher systolic pressure measured in both arms. TBI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. A TBI range of above or equal to 0.7 is considered normal, whereas a TBI less than 0.7 is considered abnormal. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  14. Change in Walking Impairment Questionnaire (WIQ) Global Score
    Change in WIQ global score from baseline to week 52 is presented. WIQ consists of three domains, speed, distance, and stair climbing, consisting of in total 14 questions. Each response is weighted based on the difficulty of the task. Domain scores are determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. Global score is calculated as the mean of the three domain scores (ranged from 0% to 100%). A global score of 0% represents inabil-ity to perform any of the tasks and 100% represents no difficulty with any of the tasks. Higher scores indicate better walking ability and less impairment. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).
  15. Change in Short Form 36 (SF-36) Physical Functioning Domain
    Change in SF-36 physical functioning domain from baseline to week 52 is presented. SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2 (acute version) questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores (Range: 19.03 to 57.60) to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A positive change score indicates an improvement in participant health stats. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan: Male or female, age above or equal to 20 years at time of signing informed consent
Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following: 1. Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview. 2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet. 3. Screening constant load treadmill test with fixed inclination of 12% and a fixed speed of 3.2 km/h (2 mph): Walking distance equal to or less than 600 meters/1968 feet. 4. Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.7 (the leg with lowest index is chosen in case of bilateral disease).
Exclusion Criteria
Current or previous treatment with any GLP-1 receptor agonist (GLP-1-RA) within 90 days prior to the day of screening.
Walking ability limited by conditions other than PAD (e.g. aortic aneurism, dysregulated arrhythmia or hypertension, angina pectoris, heart failure, chronic obstructive or restrictive pulmonary disease, Parkinson's disease, severe peripheral neuropathy, amputations, wheel chair or walker dependency, osteoarthritis, morbid obesity, severe varicose veins, etc.).
Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability).
Vascular revascularisation procedure of any kind 180 days prior to the day of screening.
Planned arterial revascularisation known on the day of screening.
Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening.
Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.

Contacts and Locations

Sponsors and CollaboratorsNovo Nordisk A/S
Locations
Cardiology, PC | Birmingham Alabama, United States, 35211Central Arkansas Veteran's Healthcare System | Little Rock Arkansas, United States, 72205Cardio Innovation & Resch Ctr | Long Beach California, United States, 90813Angel City Research, Inc. | Los Angeles California, United States, 90010St. Joseph Heritage Healthcare_Mission Viejo | Mission Viejo California, United States, 92691Rocky Mount Reg VA Med-DN | Aurora Colorado, United States, 80045Univ of Colorado at Denver | Aurora Colorado, United States, 80045Bay Area Cardiology Associates, P.A. | Brandon Florida, United States, 33511Clearwater Cardiovascular Consultants | Clearwater Florida, United States, 33756Tampa Bay Medical Research | Clearwater Florida, United States, 33761Jacksonville Ctr For Clin Res | Jacksonville Florida, United States, 32216DMI Research | Pinellas Park Florida, United States, 33782University of South Florida | Tampa Florida, United States, 33606Accel Research Site-Georgia | Eatonton Georgia, United States, 31024Reg Infectious Dis Infuse Ctr | La Grange Georgia, United States, 30240Aiyan Diabetes Center | Martinez Georgia, United States, 30907Endeavor Health Glenbook Hosp | Glenview Illinois, United States, 60026Central IL Diabetes and Clinical Research | Springfield Illinois, United States, 62701Cardiovascular Rsrch of NW_IN | Munster Indiana, United States, 46321Central Cardio Assoc HPS | Elizabethtown Kentucky, United States, 42701Cambridge Medical Trials | Alexandria Louisiana, United States, 71301LOUISIANA HEART Center | Covington Louisiana, United States, 70433Clinical Trials of Ame, LLC | Monroe Louisiana, United States, 71201Ascension Saint Agnes Heart Ca | Baltimore Maryland, United States, 21229Boston Medical Center_Cary | Boston Massachusetts, United States, 02118Minneapolis Cardiology Assoc | Minneapolis Minnesota, United States, 55407-1195Amicis Centers of Clinical Research | St Louis Missouri, United States, 63128Nebraska West Iowa Hlth System | Omaha Nebraska, United States, 68105Methodist Phys Clin Heart Cons | Omaha Nebraska, United States, 68114Dartmouth-Hitchcock Med Ctr | Lebanon New Hampshire, United States, 03766NYU Langone Med Assoc Chelsea | New York New York, United States, 10001Accellacare_NC | Wilmington North Carolina, United States, 28401Capital Area Research LLC | Camp Hill Pennsylvania, United States, 17011Penn Presb Med Ctr | Philadelphia Pennsylvania, United States, 19104Vanderbilt U Med Ctr_Nashville | Nashville Tennessee, United States, 37232PharmaTex Research | Amarillo Texas, United States, 79106Northwest Houston Cardiology, P.A. | Houston Texas, United States, 77070Houston Heart & Vascular Associates | Humble Texas, United States, 77338Texas Cardiology Associates of Houston | Kingwood Texas, United States, 77339Texas Tech University Health Science Center | Lubbock Texas, United States, 79430-8183North Dallas Research Associates | McKinney Texas, United States, 75069Victoria Heart and Vasc Ctr | Victoria Texas, United States, 77901Selma Medical Associates | Winchester Virginia, United States, 22601-3834Universitätsklinik für Innere Medizin Graz | Graz , Austria, 8036Univ.-Klinik für Innere Medizin III | Innsbruck , Austria, 6020Klinik Landstraße | Vienna , Austria, 1030AKH Wien | Vienna , Austria, 1090Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery | Bonheiden , Belgium, 2820Ziekenhuis Oost-Limburg AV - Thoracic | Genk , Belgium, 3600UZ Gent - Thoracale Vasculaire Heelkunde | Ghent , Belgium, 9000UZ Gent_Gent_1 | Ghent , Belgium, 9000AZ Groeninge - Thoracic Vascular Surgery | Kortrijk , Belgium, 8500UZ Leuven - Hart en Vaatziekten | Leuven , Belgium, 3000North York Diagn & Cardiac Ctr | North York Ontario, Canada, M6B 3H7North York Diagnostic and Cardiac Centre | North York Ontario, Canada, M6B 3H7The Ottawa Hospital, Civic Campus | Ottawa Ontario, Canada, K1Y 4E9ViaCar Recherche Clinique Inc | Brossard Quebec, Canada, J4Z 2K9Ecogene-21 | Chicoutimi Quebec, Canada, G7H 7K9Clinique Sante Cardio MC | Montreal Quebec, Canada, H1T 3Y7Montreal Heart Institute | Montreal Quebec, Canada, QC H1T 1C8CISSS des Laurentides | Saint-Jérôme Quebec, Canada, J7Z 5T3CHU de Quebec-Universite Laval | Québec , Canada, G1L 3L5Institut universitaire de cardiologie | Québec , Canada, G1V 4G5Xuanwu Hospital Capital Medical University | Beijing Beijing Municipality, China, 100053The First Bethune hospital of Jilin University-Endocrinology | Changchun Jilin, China, 130061The first hospital of Jilin University | Changchun Jilin, China, 1300611st Affiliated Hosp of Xi'an JiaoTong Uni Medical College | Xi'an Shaanxi, China, 710061The First Affiliated Hospital of Xi'an JiaoTong University-Cardiovascular | Xi'an Shaanxi, China, 710061Tianjin Union Medical Center-Cardiology | Tianjin , China, 300121Tianjin Union Medicine Centre | Tianjin , China, 300121CTC Hodonin s.r.o. | Hodonín , Czechia, 695 01EDUMED Jaromer | Jaroměř , Czechia, 55101Kucera | Ostrava Dubina , Czechia, 700 30Diabetologicka ambulance Plzen | Pilsen , Czechia, 30100II. interni klinika - klinika kardiologie a angiologie 1. LF | Prague , Czechia, 128 08Kolding Sygehus Karkirurgi | Kolding , Denmark, 6000Rigshospitalet Karkirurgisk afd. RK 3111 | København Ø , Denmark, 2100Hjerte-, Lunge- og Karkirurgisk afdeling T | Odense , Denmark, 5000Regionshospitalet Viborg - Karkirurgisk Afsnit | Viborg , Denmark, 8800Kardiologische Praxis | Bad Homburg , Germany, 61348Herz- und Diabeteszentrum NRW - Bad Oeynhausen | Bad Oeynhausen , Germany, 32545Kreutzmann | Dresden , Germany, 01277Uniklinik TU Dresden - Med. Klinik und Poliklinik III Angiologie | Dresden , Germany, 01307MVZ CCB Frankfurt und Main-Taunus GbR | Frankfurt , Germany, 60389Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck | Lübeck , Germany, 23538Universitätsmedizin der JGU Mainz - Kardiologie I | Mainz , Germany, 55131Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Münster , Germany, 48145Gemeinschaftspraxis Haggenmiller/Jeserich | Nuremberg , Germany, 90402Zentrum für klinische Studien Alexander Segner | Saint Ingbert-Oberwürzbach , Germany, 66386University Hospital of Athens ATTIKON | Athens Attica, Greece, 12462"Laiko" General Hospital of Athens | Athens , Greece, 11527Konstantopouleio G.H. of Athens, "Agia Olga" | Athens , Greece, 14233"Hygeia" General Hospital of Athens | Athens , Greece, 15123General Hospital of Chios "Skilitsio" - Cardiology Clinic | Chios , Greece, 82100General Hospital of Lamia | Lamia , Greece, 35100'Ippokrateio' General Hospital of Thessaloniki | Thessaloniki , Greece, 54642General Hospital of Thessaloniki "G.Papanikolaou" | Thessaloniki , Greece, 57010Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia | Szeged Csongrád-Csanád, Hungary, 6725Léda Platán Magánklinika | Zalaegerszeg Zala County, Hungary, 8900Szent Margit Rendelőintézet Nonprofit Kft. | Budapest , Hungary, 1032Szent Imre Egyetemi Oktatókórház Angiológia | Budapest , Hungary, 1115Semmelweis Egyetem Városmajori Szív- és Érgyógyászat | Budapest , Hungary, 1122Coromed SMO Kft. | Pécs , Hungary, 7623Sanjeevani Superspeciality Hospital | Ahmedabad Gujarat, India, 380015Shri B D Mehta Mahavir Heart Institute | Surat Gujarat, India, 395001Shri B. D. Mehta Mahavir Heart Institute | Surat Gujarat, India, 395001Shri Krishna Hrudayalaya & Critical Care Centre | Nagpur Maharashtra, India, 440012Shrikrishna Hrudayalaya and critical care centre | Nagpur Maharashtra, India, 440012Vijan Hospital & Research Centre | Nashik Maharashtra, India, 422005VMMC & Safdarjung Hospital | New Dehli New Delhi, India, 110029SP Medical College | Bikaner Rajasthan, India, 334003Osmania General Hospital | Hyderabad Telangana, India, 500012Udyaan Health Care | Lucknow Uttar Pradesh, India, 226002Sir Ganga Ram Hospital | New Delhi , India, 110060New Tokyo Heart Clinic_Matsudo-shi, Chiba, | Chiba , Japan, 271-0077Akaicho Clinic | Chiba-shi, Chiba , Japan, 260-0804Takahashi Hospital_Cardiology | Hyōgo , Japan, 654-0026Higashi Takarazuka Satoh Hospital_Cardiology | Hyōgo , Japan, 665-0873Higashi Takarazuka Satoh Hospital | Hyōgo , Japan, 665-0873Naka Kinen Clinic_Internal medicine | Ibaraki , Japan, 311-0113Naka Kinen Clinic | Ibaraki , Japan, 311-0113Nishiyamado Keiwa Hospital_Internal Medicine | Ibaraki , Japan, 331-0133Omihachiman Community Medical Center_Omihachiman-shi, Siga | Omihachiman-shi, Siga , Japan, 523-0082Minamiosaka Hospital_Internal medicine | Osaka , Japan, 559-0012Saitama Cardiovascular and Respiratory Center | Saitama , Japan, 360-0197Omi Medical Center_Cardiovascular Medicine | Shiga , Japan, 525-8585Omi Medical Center | Shiga , Japan, 525-8585Minamino Cardiovascular Hospital_Cardiovascular medicine | Tokyo , Japan, 192-0918Stradini PAD | Riga , Latvia, LV-1002Hospital Universiti Sains Malaysia | Kota Bharu Kelantan, Malaysia, 16150University Malaya Medical Centre | Lembah Pantai Kuala Lumpur, Malaysia, 59100Hospital Tengku Ampuan Afzan | Kuantan Pahang, Malaysia, 25100Hospital Pulau Pinang | George Town Pulau Pinang, Malaysia, 10990University Technology MARA (UiTM) - Sg Buloh | Sungai Buloh Selangor, Malaysia, 47000National Heart Institute | Kuala Lumpur , Malaysia, 50400Hospital Queen Elizabeth II | Sabak Bernam , Malaysia, 88300Haukeland universitetssykehus - Karkirurgisk avdeling | Bergen , Norway, 5021Sørlandet sykehus HF Kristiansand | Kristiansand , Norway, 4615OUS, Aker | Oslo , Norway, 0586Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET | Krakow Lesser Poland Voivodeship, Poland, 31-261UniCardia & UniMedica & UniEstetica | Krakow , Poland, 31-271Centrum Medyczne OMEDICA | Poznan , Poland, 60-111Velocity Nova Sp. z o.o. | Puławy , Poland, 24-100Gabinety Lekarskie LabMed | Szczecin , Poland, 71-531Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego | Warsaw , Poland, 04-628DoktorA | Warsaw , Poland, 05-077Centrum Badan Klinicznych | Wroclaw , Poland, 51-162Multispecialty Medical Clinic Anturium LLC | Barnaul , Russia, 656043Road Clinical Hospital at station Chelyabinsk | Chelyabinsk , Russia, 454048Irkutsk State Medical Academy of Postgraduate Education | Irkutsk , Russia, 664049Limited Liability Company "Alliance Biomedical Ural Group" | Izhevsk , Russia, 426061SRMC "Your Health" LLC | Kazan' , Russia, 420097FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia | Moscow , Russia, 117292Federal Bureau for Medical and Social Expertise | Moscow , Russia, 127486Pirogov Russian National Research Medical University MoH | Moscow , Russia, 129226LLC RC Medical | Novosibirsk , Russia, 630005SGIoH of Novosibirsk region "CC Hospital #19" | Novosibirsk , Russia, 630068State Novosibirsk regional clinical hospital | Novosibirsk , Russia, 630087LLC "Clinical diagnostic center Ultramed" | Omsk , Russia, 644024Ryazan State Medical University | Ryazan , Russia, 390026Joint Stock Company "Polyclinic Complex" | Saint Petersburg , Russia, 190013Limited Liability Company "Clinic" MEDINEF " | Saint Petersburg , Russia, 194044Limited Liability Company "Energiya Zdoroviya" | Saint Petersburg , Russia, 194156SGHI "Polyclinic #106" | Saint Petersburg , Russia, 198328Regional clinical cardiology dispensary | Saratov , Russia, 410028SHI Saratov City Clinical Hospital #9 | Saratov , Russia, 410031Voronezh Regional Clinical Consultive-diagnostic Centre | Voronezh , Russia, 394018Polyclinic #2 in Yoshkar-Ola | Yoshkar-Ola , Russia, 424004Centro Periférico de Especialidades Bola Azul | Almería , Spain, 04009Hospital Reina Sofia | Córdoba , Spain, 14004Hospital Universitario de la Princesa | Madrid , Spain, 28006Hospital Gregorio Marañón | Madrid , Spain, 28009Hospital Civil de Málaga | Málaga , Spain, 29009Hospital Virgen de la Macarena | Seville , Spain, 41009Hospital Vithas Sevilla | Seville , Spain, 41950Kärlkirurgen/kärllab | Gothenburg , Sweden, 413 45Kärlmottagningen | Uppsala , Sweden, 751 85Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City , Taiwan, 807China Medical University Hospital | Taichung , Taiwan, 404Kuang Tien General Hospital | Taichung , Taiwan, 433National Cheng Kung University Hospital | Tainan , Taiwan, 704National Taiwan University Hospital_main | Taipei , Taiwan, 100Taipei Veterans General Hospital | Taipei , Taiwan, 112Chang Gung Medical Foundation - Linkou Branch | Taoyuan , Taiwan, 333Srinagarind Hospital | Muang Changwat Khon Kaen, Thailand, 40002King Chulalongkorn Memorial Hospital, Cardiology department | Bangkok , Thailand, 10330Phramongkutklao Hospital-cardio | Bangkok , Thailand, 10400Research Institute for Health Sciences, CMU | Chiang Mai , Thailand, 50200Rihes - Research Institute for Health Sciences | Chiang Mai , Thailand, 50200Srinagarind Hospital | Khon Kaen , Thailand, 40002Maharat Nakhon Ratchasima Hospital_Ratchasima | Nakhon Ratchasima , Thailand, 30000Maharat Nakhon Ratchasima Hospital_ | Nakhon Ratchasima , Thailand, 30000Thammasat University Hospital_Pathumthani | Pathum Thani , Thailand, 12120Songklanagarind Hospital | Songkhla , Thailand, 90110
Investigators
Study Director: Clinical Transparency (1452), Novo Nordisk A/S
Study Documents (Full Text)
Documents provided by Novo Nordisk A/S: Study Protocol  April 17, 2023Documents provided by Novo Nordisk A/S: Statistical Analysis Plan  August 25, 2024