{"protocolSection":{"identificationModule":{"nctId":"NCT03914326","orgStudyIdInfo":{"id":"EX9924-4473"},"secondaryIdInfos":[{"id":"2018-003141-42","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"U1111-1218-5368","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2018","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2018"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes","officialTitle":"Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes","acronym":"SOUL"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-06-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-08-23","type":"ACTUAL"},"completionDateStruct":{"date":"2024-08-23","type":"ACTUAL"},"studyFirstSubmitDate":"2019-04-11","studyFirstSubmitQcDate":"2019-04-11","studyFirstPostDateStruct":{"date":"2019-04-16","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-08-10","resultsFirstSubmitQcDate":"2025-09-19","resultsFirstPostDateStruct":{"date":"2025-09-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-24","lastUpdatePostDateStruct":{"date":"2025-12-11","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets (\"dummy\" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":9651,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Oral semaglutide","type":"EXPERIMENTAL","description":"One tablet daily for 3.5 to 5 years","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"One tablet daily for 3.5 to 5 years","interventionNames":["Drug: Placebo (semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state","armGroupLabels":["Oral semaglutide"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"Placebo tablets to be taken with water at the same time every morning in a fasting state","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants From Randomization to First Occurrence of a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal Stroke","description":"Number of participants with first occurrence of EAC (event adjudication committee) confirmed major adverse cardiovascular event (MACE), a composite end-point. i.e., from time of randomization to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction and non-fatal stroke combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"}],"secondaryOutcomes":[{"measure":"Number of Participants From Randomization to First Occurrence of CV Death;Renal Death;Onset of Persistent≥50% Reduction in eGFR(CKD-EPI);Onset of Persistent eGFR(CKD-EPI)<15 mL/Min/1.73m^2;Initiation of Chronic Renal Replacement Therapy","description":"Number of participants with first occurrence of a composite endpoint. i.e., from time of randomization to first occurrence of CV death, renal death, onset of persistent greater than or equal to (≥) 50% reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease epidemiology collaboration CKD-EPI), onset of persistent eGFR (CKD-EPI) less than (\\<)15 milliliters per minute per 1.73 square meters (mL/min/1.73 m\\^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation) combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomization to Time of Occurrence of CV Death","description":"Number of participants from time of randomization to time to occurrence of EAC confirmed CV death during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomization to First Occurrence of Major Adverse Limb Events (MALE), a Composite Endpoint Consisting of: Acute Limb Ischemia Hospitalisation/Chronic Limb Ischemia Hospitalisation","description":"Number of participants from randomization to first occurrence of EAC confirmed major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of an Expanded MACE Composite Endpoint Consisting of: CV Death/Non-fatal Myocardial Infarction/ Non-fatal Stroke/Coronary Revascularisation/Unstable Angina Pectoris Requiring Hospitalisation","description":"The number of participants from randomisation to first occurrence of an expanded MACE composite endpoint consisting of: CV death/non-fatal myocardial infarction/ non-fatal stroke/coronary revascularisation/unstable angina pectoris requiring hospitalisation combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of a Composite Endpoint Consisting of : All-cause Death/ Non-fatal MI/ Non-fatal Stroke","description":"The number of participants from randomisation to first occurrence of EAC confirmed composite endpoint consisting of : all-cause death/ non-fatal MI/ non-fatal stroke combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of a Composite Heart Failure Endpoint Consisting of: CV Death/Heart Failure Requiring Hospitalisation/Urgent Heart Failure Visit","description":"Number of participants from randomisation to first occurrence of EAC confirmed composite heart failure endpoint consisting of: CV death/heart failure requiring hospitalisation/urgent heart failure visit combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomization to First Occurrence of CKD Endpoint:Renal Death;Onset of Persistent≥50% Reduction in eGFR (CKD-EPI);Onset of Persistent eGFR(CKD-EPI)<15 mL/Min/1.73 m^2;Initiation of Chronic Renal Replacement Therapy","description":"The number of participants from randomization to first occurrence of CKD endpoint:renal death;onset of persistent≥50% reduction in eGFR (CKD-EPI);onset of persistent eGFR(CKD-EPI)\\<15 mL/min/1.73 m\\^2;initiation of chronic renal replacement therapy combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to Time to Occurrence of All-cause Death","description":"The number of participants from randomisation to time to occurrence of EAC confirmed all-cause death during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Non-fatal Myocardial Infarction (MI)","description":"The number of participants from randomisation to first occurrence of EAC confirmed non-fatal MI during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Non-fatal Stroke","description":"The number of participants from randomisation to first occurrence of EAC confirmed non-fatal stroke during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Heart Failure Requiring Hospitalisation or Urgent Heart Failure Visit","description":"The number of participants from randomisation to first occurrence of EAC confirmed heart failure requiring hospitalisation or urgent heart failure visit during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Coronary Revascularisation","description":"The number of participants from randomisation to first occurrence of coronary revascularisation during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Unstable Angina Requiring Hospitalisation","description":"The number of participants from randomisation to first occurrence of EAC confirmed unstable angina requiring hospitalisation during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to Time to Occurrence of Renal Death","description":"The number of participants from randomisation to time to occurrence of EAC confirmed renal death during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Onset of Persistent 50% or More Reduction in eGFR","description":"The number of participants from randomisation to first occurrence of onset of persistent 50% or more reduction in eGFR during in-trial period were observed. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Onset of Persistent eGFR (CKD-EPI) Below 15 mL/Min/1.73 m^2","description":"The number of participants from randomisation to first occurrence of onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m\\^2 during in-trial period were observed. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Initiation of Chronic Renal Replacement Therapy (Dialysis or Kidney Transplantation)","description":"The number of participants from randomisation to first occurrence of EAC confirmed initiation of chronic renal replacement therapy (dialysis or kidney transplantation) during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Acute Limb Ischemia","description":"The number of participants from randomisation to first occurrence of EAC confirmed acute limb ischaemia hospitalization during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of Chronic Limb Ischemia Hospitalisation","description":"The number of participants from randomisation to first occurrence of EAC confirmed chronic limb ischaemia hospitalization during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)","description":"Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported during in trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 260"},{"measure":"Change From Baseline in Glycosylated Haemoglobin (HbA1c)","description":"Change in HbA1c from baseline (Week 0) up to Week 104 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baseline (Week 0), Week 104"},{"measure":"Change From Baseline in Body Weight","description":"Change in body weight from baseline (Week 0) up to Week 104 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baseline (Week 0), Week 104"},{"measure":"Number of Severe Hypoglycaemic Episodes","description":"The number of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) observed during the in-trial period were reported in this endpoint. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"},{"measure":"Number of Participants From Randomisation to First Occurrence of a Severe Hypoglycaemic Episode","description":"The number of participants from randomisation to first occurrence of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From randomisation (week 0) up to week 265"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age equal to or above 50 years at the time of signing informed consent\n* Diagnosed with type 2 diabetes mellitus\n* HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement)\n* At least one of the below conditions (a-d):\n\n  a) Coronary heart disease defined as at least one of the following: i. Prior myocardial infarction ii. Prior coronary revascularisation procedure iii. 50% or above stenosis in coronary artery documented by cardiac catheterisation, computerized tomography coronary angiography iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke ii. Prior carotid artery revascularisation procedure iii.50% or above stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest ii. Intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularization procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) d) Chronic kidney disease defined as: i. eGFR below 60 mL/min/1.73 m\\^2 (based on medical records using latest available and no more than 6 months old assessment)\n\nExclusion Criteria:\n\n* Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening\n* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\n* Heart failure presently classified as being in New York Heart Association Class IV\n* Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening","healthyVolunteers":false,"sex":"ALL","minimumAge":"50 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Reporting Anchor and Disclosure (1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Chambliss Clinical Trials, LLC","city":"Montgomery","state":"Alabama","zip":"36106","country":"United States","geoPoint":{"lat":32.36681,"lon":-86.29997}},{"facility":"Medical Investigations, Inc.","city":"Little Rock","state":"Arkansas","zip":"72211","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"Unity Health-Searcy Medical Center","city":"Searcy","state":"Arkansas","zip":"72143","country":"United States","geoPoint":{"lat":35.25064,"lon":-91.73625}},{"facility":"B&K Medical Research Center","city":"Fresno","state":"California","zip":"93721-1443","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"University of Vermont Medical Center","city":"Fullerton","state":"California","zip":"92835","country":"United States","geoPoint":{"lat":33.87029,"lon":-117.92534}},{"facility":"Scripps Whittier Diabetes Inst","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"Diabetes & Endocrine Associates","city":"La Mesa","state":"California","zip":"91942","country":"United States","geoPoint":{"lat":32.76783,"lon":-117.02308}},{"facility":"First Valley Medical Group","city":"Lancaster","state":"California","zip":"93534","country":"United States","geoPoint":{"lat":34.69804,"lon":-118.13674}},{"facility":"Pacific Clinical Studies","city":"Los Alamitos","state":"California","zip":"90720","country":"United States","geoPoint":{"lat":33.80307,"lon":-118.07256}},{"facility":"Facey Medical Foundation","city":"Mission Hills","state":"California","zip":"91345","country":"United States","geoPoint":{"lat":34.68609,"lon":-120.43683}},{"facility":"Monterey Endocrine & Diabetes Institute, Inc","city":"Monterey","state":"California","zip":"93940","country":"United States","geoPoint":{"lat":36.60024,"lon":-121.89468}},{"facility":"Desert Oasis Hlthcr Med Group","city":"Palm Springs","state":"California","zip":"92262","country":"United States","geoPoint":{"lat":33.8303,"lon":-116.54529}},{"facility":"San Diego Family Care","city":"San Diego","state":"California","zip":"92111","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Lundquist Inst-Biomed Innovtn","city":"Torrance","state":"California","zip":"90502","country":"United States","geoPoint":{"lat":33.83585,"lon":-118.34063}},{"facility":"Coastal Metabolic Research Center","city":"Ventura","state":"California","zip":"93003","country":"United States","geoPoint":{"lat":34.27834,"lon":-119.29317}},{"facility":"Rocky Mount Reg VA Med-DN","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Creekside Endocrine Associates, PC","city":"Denver","state":"Colorado","zip":"80246","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"New West Physicians,Inc.","city":"Golden","state":"Colorado","zip":"80401","country":"United States","geoPoint":{"lat":39.75554,"lon":-105.2211}},{"facility":"East Coast Medical Associates, Inc.","city":"Boca Raton","state":"Florida","zip":"33433","country":"United States","geoPoint":{"lat":26.35869,"lon":-80.0831}},{"facility":"Suncoast Clin Res Port Richey","city":"New Port Richey","state":"Florida","zip":"34652","country":"United States","geoPoint":{"lat":28.24418,"lon":-82.71927}},{"facility":"AdventHealth Diab Inst","city":"Orlando","state":"Florida","zip":"32804","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Ellipsis Group","city":"Alpharetta","state":"Georgia","zip":"30022","country":"United States","geoPoint":{"lat":34.07538,"lon":-84.29409}},{"facility":"Physicians Research Assoc. 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Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes: A Post Hoc Secondary Analysis of the SOUL Randomized Clinical Trial. JAMA Cardiol. 2026 May 1;11(5):427-437. doi: 10.1001/jamacardio.2026.0245."},{"pmid":"41627802","type":"DERIVED","citation":"Pop-Busui R, Rasmussen S, Deanfield JE, Buse JB, Marx N, Mulvagh SL, Inzucchi SE, Mann JFE, Emerson SS, Poulter NR, Engelmann MDM, Hovingh GK, Bayer Tanggaard K, Birkenfeld AL, Connelly KA, Haluzik M, Cavender MA, Kellerer M, Jhund PS, Gregersen S, Nielsen OW, Lam CSP, McGuire DK; SOUL Study Group. Oral Semaglutide and Heart Failure Outcomes in Persons With Type 2 Diabetes: A Secondary Analysis of the SOUL Randomized Clinical Trial. JAMA Intern Med. 2026 Apr 1;186(4):426-436. doi: 10.1001/jamainternmed.2025.7774."},{"pmid":"41380027","type":"DERIVED","citation":"Mann JFE, Marx N, Deanfield JE, Emerson SS, Inzucchi SE, McGuire DK, Mulvagh SL, Pop-Busui R, Poulter NR, Engelmann MDM, Hovingh GK, Belmar N, Idorn T, Jeppesen OK, Birkenfeld AL, Amod A, Mankovsky B, Desouza C, Gorgojo-Martinez JJ, Arechavaleta R, Tu ST, Buse JB; SOUL Study Group*. Impact of Oral Semaglutide on Kidney Outcomes in People With Type 2 Diabetes: Results From the SOUL Randomized Trial. Diabetes Care. 2026 Feb 1;49(2):257-265. doi: 10.2337/dc25-1080."},{"pmid":"41099689","type":"DERIVED","citation":"Borlaug BA, Holse C, Jung MH, Lincoff AM, Mulvagh SL, Staerk-Ostergaard J, Tuttle KR, Petrie MC. Prevalence and Associations of Systemic Inflammation in Heart Failure Across the Spectrum of Ejection Fraction. JACC Heart Fail. 2026 Feb;14(2):102712. doi: 10.1016/j.jchf.2025.102712. Epub 2025 Oct 16."},{"pmid":"40162642","type":"DERIVED","citation":"McGuire DK, Marx N, Mulvagh SL, Deanfield JE, Inzucchi SE, Pop-Busui R, Mann JFE, Emerson SS, Poulter NR, Engelmann MDM, Ripa MS, Hovingh GK, Brown-Frandsen K, Bain SC, Cavender MA, Gislum M, David JP, Buse JB; SOUL Study Group. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. N Engl J Med. 2025 May 29;392(20):2001-2012. doi: 10.1056/NEJMoa2501006. Epub 2025 Mar 29."},{"pmid":"40156843","type":"DERIVED","citation":"Marx N, Deanfield JE, Mann JFE, Arechavaleta R, Bain SC, Bajaj HS, Bayer Tanggaard K, Birkenfeld AL, Buse JB, Davicevic-Elez Z, Desouza C, Emerson SS, Engelmann MDM, Hovingh GK, Inzucchi SE, Jhund PS, Mulvagh SL, Pop-Busui R, Poulter NR, Rasmussen S, Tu ST, McGuire DK; SOUL Study Group. Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial. Circulation. 2025 Jun 10;151(23):1639-1650. doi: 10.1161/CIRCULATIONAHA.125.074545. Epub 2025 Mar 29."},{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 9,651 participants were enrolled/randomized (1:1) to treatment with oral semaglutide (4,825 participants) or placebo (4,826 participants). One participant was randomised twice in the trial. Thus, the FAS comprised 9,650 participants (4,825 participants in the oral semaglutide group and 4,825 participants in the placebo group).","recruitmentDetails":"The trial was conducted at 446 sites in 34 countries.","groups":[{"id":"FG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"FG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4825"},{"groupId":"FG001","numSubjects":"4826"}]},{"type":"Full Analysis 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unique randomised participants and were grouped according to the treatment assigned at randomization.","groups":[{"id":"BG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"BG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4825"},{"groupId":"BG001","value":"4825"},{"groupId":"BG002","value":"9650"}]}],"measures":[{"title":"Age, 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cardiovascular event (MACE), a composite end-point. i.e., from time of randomization to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction and non-fatal stroke combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"579"},{"groupId":"OG001","value":"668"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor.","pValue":"0.0028","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.77","ciUpperLimit":"0.96"}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to First Occurrence of CV Death;Renal Death;Onset of Persistent≥50% Reduction in eGFR(CKD-EPI);Onset of Persistent eGFR(CKD-EPI)<15 mL/Min/1.73m^2;Initiation of Chronic Renal Replacement Therapy","description":"Number of participants with first occurrence of a composite endpoint. i.e., from time of randomization to first occurrence of CV death, renal death, onset of persistent greater than or equal to (≥) 50% reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease epidemiology collaboration CKD-EPI), onset of persistent eGFR (CKD-EPI) less than (\\<)15 milliliters per minute per 1.73 square meters (mL/min/1.73 m\\^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation) combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"435"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to Time of Occurrence of CV Death","description":"Number of participants from time of randomization to time to occurrence of EAC confirmed CV death during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"320"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to First Occurrence of Major Adverse Limb Events (MALE), a Composite Endpoint Consisting of: Acute Limb Ischemia Hospitalisation/Chronic Limb Ischemia Hospitalisation","description":"Number of participants from randomization to first occurrence of EAC confirmed major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"99"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of an Expanded MACE Composite Endpoint Consisting of: CV Death/Non-fatal Myocardial Infarction/ Non-fatal Stroke/Coronary Revascularisation/Unstable Angina Pectoris Requiring Hospitalisation","description":"The number of participants from randomisation to first occurrence of an expanded MACE composite endpoint consisting of: CV death/non-fatal myocardial infarction/ non-fatal stroke/coronary revascularisation/unstable angina pectoris requiring hospitalisation combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"670"},{"groupId":"OG001","value":"777"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of a Composite Endpoint Consisting of : All-cause Death/ Non-fatal MI/ Non-fatal Stroke","description":"The number of participants from randomisation to first occurrence of EAC confirmed composite endpoint consisting of : all-cause death/ non-fatal MI/ non-fatal stroke combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"779"},{"groupId":"OG001","value":"902"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of a Composite Heart Failure Endpoint Consisting of: CV Death/Heart Failure Requiring Hospitalisation/Urgent Heart Failure Visit","description":"Number of participants from randomisation to first occurrence of EAC confirmed composite heart failure endpoint consisting of: CV death/heart failure requiring hospitalisation/urgent heart failure visit combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"405"},{"groupId":"OG001","value":"443"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to First Occurrence of CKD Endpoint:Renal Death;Onset of Persistent≥50% Reduction in eGFR (CKD-EPI);Onset of Persistent eGFR(CKD-EPI)<15 mL/Min/1.73 m^2;Initiation of Chronic Renal Replacement Therapy","description":"The number of participants from randomization to first occurrence of CKD endpoint:renal death;onset of persistent≥50% reduction in eGFR (CKD-EPI);onset of persistent eGFR(CKD-EPI)\\<15 mL/min/1.73 m\\^2;initiation of chronic renal replacement therapy combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"129"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to Time to Occurrence of All-cause Death","description":"The number of participants from randomisation to time to occurrence of EAC confirmed all-cause death during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"528"},{"groupId":"OG001","value":"577"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Non-fatal Myocardial Infarction (MI)","description":"The number of participants from randomisation to first occurrence of EAC confirmed non-fatal MI during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"253"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Non-fatal Stroke","description":"The number of participants from randomisation to first occurrence of EAC confirmed non-fatal stroke during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"161"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Heart Failure Requiring Hospitalisation or Urgent Heart Failure Visit","description":"The number of participants from randomisation to first occurrence of EAC confirmed heart failure requiring hospitalisation or urgent heart failure visit during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"167"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Coronary Revascularisation","description":"The number of participants from randomisation to first occurrence of coronary revascularisation during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"263"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Unstable Angina Requiring Hospitalisation","description":"The number of participants from randomisation to first occurrence of EAC confirmed unstable angina requiring hospitalisation during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"80"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to Time to Occurrence of Renal Death","description":"The number of participants from randomisation to time to occurrence of EAC confirmed renal death during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Onset of Persistent 50% or More Reduction in eGFR","description":"The number of participants from randomisation to first occurrence of onset of persistent 50% or more reduction in eGFR during in-trial period were observed. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"86"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Onset of Persistent eGFR (CKD-EPI) Below 15 mL/Min/1.73 m^2","description":"The number of participants from randomisation to first occurrence of onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m\\^2 during in-trial period were observed. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"33"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Initiation of Chronic Renal Replacement Therapy (Dialysis or Kidney Transplantation)","description":"The number of participants from randomisation to first occurrence of EAC confirmed initiation of chronic renal replacement therapy (dialysis or kidney transplantation) during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"48"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Acute Limb Ischemia","description":"The number of participants from randomisation to first occurrence of EAC confirmed acute limb ischaemia hospitalization during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"17"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of Chronic Limb Ischemia Hospitalisation","description":"The number of participants from randomisation to first occurrence of EAC confirmed chronic limb ischaemia hospitalization during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"88"}]}]}]},{"type":"SECONDARY","title":"Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)","description":"Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported during in trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure\" also.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"ml/min/1.73 m^2 per year","timeFrame":"From randomisation (week 0) up to week 260","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4819"},{"groupId":"OG001","value":"4822"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.67","spread":"0.0"},{"groupId":"OG001","value":"-2.06","spread":"0.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Glycosylated Haemoglobin (HbA1c)","description":"Change in HbA1c from baseline (Week 0) up to Week 104 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure\" also.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline (Week 0), Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4076"},{"groupId":"OG001","value":"4004"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.71","spread":"1.22"},{"groupId":"OG001","value":"-0.15","spread":"1.19"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"Change in body weight from baseline (Week 0) up to Week 104 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure\" also.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline (Week 0), Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4251"},{"groupId":"OG001","value":"4155"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.21","spread":"5.85"},{"groupId":"OG001","value":"-1.28","spread":"4.90"}]}]}]},{"type":"SECONDARY","title":"Number of Severe Hypoglycaemic Episodes","description":"The number of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) observed during the in-trial period were reported in this endpoint. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From randomisation (week 0) up to week 265","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260)."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4825"},{"groupId":"OG001","value":"4825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"121"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomisation to First Occurrence of a Severe Hypoglycaemic Episode","description":"The number of participants from randomisation to first occurrence of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) during in-trial period were reported. 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