{"protocolSection":{"identificationModule":{"nctId":"NCT01720446","orgStudyIdInfo":{"id":"NN9535-3744"},"secondaryIdInfos":[{"id":"2012-002839-28","type":"EUDRACT_NUMBER"},{"id":"U1111-1131-7227","type":"OTHER","domain":"WHO"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes","officialTitle":"A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)","acronym":"SUSTAIN™ 6"},"statusModule":{"statusVerifiedDate":"2019-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-02-21","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-03-15","type":"ACTUAL"},"completionDateStruct":{"date":"2016-03-15","type":"ACTUAL"},"studyFirstSubmitDate":"2012-10-29","studyFirstSubmitQcDate":"2012-10-31","studyFirstPostDateStruct":{"date":"2012-11-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-12-14","resultsFirstSubmitQcDate":"2018-02-15","resultsFirstPostDateStruct":{"date":"2018-03-15","type":"ACTUAL"},"dispFirstSubmitDate":"2016-12-13","dispFirstSubmitQcDate":"2016-12-13","dispFirstPostDateStruct":{"date":"2016-12-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-06-20","lastUpdatePostDateStruct":{"date":"2019-06-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":3297,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 0.5 mg","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Semaglutide 1.0 mg","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Semaglutide placebo 0.5 mg","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]},{"label":"Semaglutide placebo 1.0 mg","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)","armGroupLabels":["Semaglutide 0.5 mg"]},{"type":"DRUG","name":"semaglutide","description":"Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)","armGroupLabels":["Semaglutide 1.0 mg"]},{"type":"DRUG","name":"placebo","description":"Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).","armGroupLabels":["Semaglutide placebo 0.5 mg","Semaglutide placebo 1.0 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke","description":"Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.","timeFrame":"Time from randomisation up to end of follow-up (scheduled at week 109)"}],"secondaryOutcomes":[{"measure":"Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome","description":"Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation \\[coronary and peripheral\\], unstable angina requiring hospitalisation or hospitalisation for heart failure)","timeFrame":"Time from randomisation up to end of follow-up (scheduled at week 109)"},{"measure":"Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome","description":"Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation \\[coronary and peripheral\\], unstable angina requiring hospitalisation or hospitalisation for heart failure).","timeFrame":"Time from randomisation up to end of follow-up (scheduled at week 109)"},{"measure":"Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke","description":"Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.","timeFrame":"Time from randomisation up to end of follow-up (scheduled at week 109)"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)","description":"Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.","timeFrame":"Week 0, up to week 104"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose","description":"Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.","timeFrame":"Week 0, up to week 104"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight","description":"Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.","timeFrame":"Week 0, up to week 104"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile","description":"Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).","timeFrame":"Week 0, up to week 104"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio","description":"Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.","timeFrame":"Week 0, up to week 104"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs","description":"Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).","timeFrame":"Week 0, up to week 104"},{"measure":"Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events","description":"Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.","timeFrame":"Week 0 - 109"},{"measure":"Incidence During the Trial in Other Treatment Outcomes: Adverse Events","description":"Rates (event rate per 100 years of exposure) of treatment emergent adverse events.","timeFrame":"Weeks 0-109"},{"measure":"Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies","description":"The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.","timeFrame":"Weeks 0-109"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)","description":"Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.","timeFrame":"Week 0, up to week 104"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)","description":"Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).","timeFrame":"Week 0, up to week 104"},{"measure":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)","description":"Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).","timeFrame":"Week 0, up to week 104"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria: - Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and 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screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L","healthyVolunteers":false,"sex":"ALL","minimumAge":"50 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35205-4731","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk 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Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2."},{"pmid":"27633186","type":"RESULT","citation":"Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15."},{"pmid":"29178519","type":"RESULT","citation":"Vilsboll T, Bain SC, Leiter LA, Lingvay I, Matthews D, Simo R, Helmark IC, Wijayasinghe N, Larsen M. Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy. Diabetes Obes Metab. 2018 Apr;20(4):889-897. doi: 10.1111/dom.13172. Epub 2018 Jan 8."},{"pmid":"29907893","type":"RESULT","citation":"Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15."},{"pmid":"30615985","type":"RESULT","citation":"Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4."},{"pmid":"31167654","type":"RESULT","citation":"Leiter LA, Bain SC, Hramiak I, Jodar E, Madsbad S, Gondolf T, Hansen T, Holst I, Lingvay I. Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial. Cardiovasc Diabetol. 2019 Jun 6;18(1):73. doi: 10.1186/s12933-019-0871-8."},{"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."},{"pmid":"39520501","type":"DERIVED","citation":"Bain SC, Belmar N, Hoff ST, Husain M, Rasmussen S, Vilsboll T, Petrie MC. Cardiovascular, Metabolic, and Safety Outcomes with Semaglutide by Baseline Age: Post Hoc Analysis of SUSTAIN 6 and PIONEER 6. Diabetes Ther. 2025 Jan;16(1):15-28. doi: 10.1007/s13300-024-01659-7. Epub 2024 Nov 9."},{"pmid":"37620807","type":"DERIVED","citation":"Rossing P, Bain SC, Bosch-Traberg H, Sokareva E, Heerspink HJL, Rasmussen S, Mellbin LG. Effect of semaglutide on major adverse cardiovascular events by baseline kidney parameters in participants with type 2 diabetes and at high risk of cardiovascular disease: SUSTAIN 6 and PIONEER 6 post hoc pooled analysis. Cardiovasc Diabetol. 2023 Aug 24;22(1):220. doi: 10.1186/s12933-023-01949-7."},{"pmid":"35582947","type":"DERIVED","citation":"Strain WD, Frenkel O, James MA, Leiter LA, Rasmussen S, Rothwell PM, Sejersten Ripa M, Truelsen TC, Husain M. Effects of Semaglutide on Stroke Subtypes in Type 2 Diabetes: Post Hoc Analysis of the Randomized SUSTAIN 6 and PIONEER 6. Stroke. 2022 Sep;53(9):2749-2757. doi: 10.1161/STROKEAHA.121.037775. Epub 2022 May 18."},{"pmid":"35484580","type":"DERIVED","citation":"Husain M, Consoli A, De Remigis A, Pettersson Meyer AS, Rasmussen S, Bain S. Semaglutide reduces cardiovascular events regardless of metformin use: a post hoc subgroup analysis of SUSTAIN 6 and PIONEER 6. Cardiovasc Diabetol. 2022 Apr 28;21(1):64. doi: 10.1186/s12933-022-01489-6."},{"pmid":"35332654","type":"DERIVED","citation":"Verma S, Al-Omran M, Leiter LA, Mazer CD, Rasmussen S, Saevereid HA, Sejersten Ripa M, Bonaca MP. Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease. Diabetes Obes Metab. 2022 Jul;24(7):1288-1299. doi: 10.1111/dom.14700. Epub 2022 Apr 11."},{"pmid":"33606902","type":"DERIVED","citation":"Verma S, Fainberg U, Husain M, Rasmussen S, Ryden L, Ripa MS, Buse JB. Applying REWIND cardiovascular disease criteria to SUSTAIN 6 and PIONEER 6: An exploratory analysis of cardiovascular outcomes with semaglutide. Diabetes Obes Metab. 2021 Jul;23(7):1677-1680. doi: 10.1111/dom.14360. Epub 2021 Mar 18."},{"pmid":"32998732","type":"DERIVED","citation":"Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4."},{"pmid":"32744418","type":"DERIVED","citation":"Verma S, McGuire DK, Bain SC, Bhatt DL, Leiter LA, Mazer CD, Monk Fries T, Pratley RE, Rasmussen S, Vrazic H, Zinman B, Buse JB. Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Dec;22(12):2487-2492. doi: 10.1111/dom.14160. Epub 2020 Sep 4."},{"pmid":"32643857","type":"DERIVED","citation":"Verma S, Bain SC, Honore JB, F E Mann J, A Nauck M, E Pratley R, Rasmussen S, Sejersten Ripa M, Zinman B, Buse JB. Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2020 Nov;22(11):2193-2198. doi: 10.1111/dom.14140. Epub 2020 Aug 12."},{"pmid":"32372454","type":"DERIVED","citation":"Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3."},{"pmid":"32227613","type":"DERIVED","citation":"Jodar E, Michelsen M, Polonsky W, Rea R, Sandberg A, Vilsboll T, Warren M, Harring S, Ziegler U, Bain S. Semaglutide improves health-related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6). Diabetes Obes Metab. 2020 Aug;22(8):1339-1347. doi: 10.1111/dom.14039. Epub 2020 Apr 27."},{"pmid":"31903692","type":"DERIVED","citation":"Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5."},{"pmid":"31769496","type":"DERIVED","citation":"DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072."},{"pmid":"29693361","type":"DERIVED","citation":"Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects could be anti-glycaemic drug naïve, or treated with 1 or 2 oral anti diabetic drugs (OADs), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, alone or in combination with 1 or 2 OAD(s).","recruitmentDetails":"The trial was conducted at 229 sites in 20 countries. Country (sites): Algeria (4), Argentina (7), Australia (8), Brazil (8), Bulgaria (5), Canada (13), Denmark (5), Germany (7), Israel (6), Italy (6), Malaysia (6), Mexico (9), Poland (5), Russia (11), Spain (6), Taiwan (4), Thailand (5), Turkey (10), United Kingdom (8) and United States (96).","groups":[{"id":"FG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"FG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"FG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"FG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"826"},{"groupId":"FG001","numSubjects":"822"},{"groupId":"FG002","numSubjects":"824"},{"groupId":"FG003","numSubjects":"825"}]},{"type":"Premature Treatment Discontinuers","achievements":[{"groupId":"FG000","comment":"Premature treatment discontinuers were allowed to continue participation in the trial.","numSubjects":"164"},{"groupId":"FG001","comment":"Premature treatment discontinuers were allowed to continue participation in the trial.","numSubjects":"186"},{"groupId":"FG002","comment":"Premature treatment discontinuers were allowed to continue participation in the trial.","numSubjects":"151"},{"groupId":"FG003","comment":"Premature treatment discontinuers were allowed to continue participation in the trial.","numSubjects":"159"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Subjects who did not permanently discontinue treatment prematurely.","numSubjects":"812"},{"groupId":"FG001","comment":"Subjects who did not permanently discontinue treatment prematurely.","numSubjects":"811"},{"groupId":"FG002","comment":"Subjects who did not permanently discontinue treatment prematurely.","numSubjects":"804"},{"groupId":"FG003","comment":"Subjects who did not permanently discontinue treatment prematurely.","numSubjects":"805"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"20"},{"groupId":"FG003","numSubjects":"20"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"16"},{"groupId":"FG003","numSubjects":"16"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Analysis was performed on full analysis set which included all randomised subjects.","groups":[{"id":"BG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"BG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"BG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"BG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"826"},{"groupId":"BG001","value":"822"},{"groupId":"BG002","value":"824"},{"groupId":"BG003","value":"825"},{"groupId":"BG004","value":"3297"}]}],"measures":[{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"50-64 years","categories":[{"measurements":[{"groupId":"BG000","value":"440"},{"groupId":"BG001","value":"415"},{"groupId":"BG002","value":"419"},{"groupId":"BG003","value":"425"},{"groupId":"BG004","value":"1699"}]}]},{"title":"65-74 years","categories":[{"measurements":[{"groupId":"BG000","value":"312"},{"groupId":"BG001","value":"324"},{"groupId":"BG002","value":"324"},{"groupId":"BG003","value":"317"},{"groupId":"BG004","value":"1277"}]}]},{"title":"75-84 years","categories":[{"measurements":[{"groupId":"BG000","value":"71"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"75"},{"groupId":"BG003","value":"79"},{"groupId":"BG004","value":"301"}]}]},{"title":"85 and over","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"20"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"331"},{"groupId":"BG001","value":"304"},{"groupId":"BG002","value":"342"},{"groupId":"BG003","value":"318"},{"groupId":"BG004","value":"1295"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"495"},{"groupId":"BG001","value":"518"},{"groupId":"BG002","value":"482"},{"groupId":"BG003","value":"507"},{"groupId":"BG004","value":"2002"}]}]}]},{"title":"Glycosylated haemoglobin","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated haemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.67","spread":"1.39"},{"groupId":"BG001","value":"8.73","spread":"1.51"},{"groupId":"BG002","value":"8.70","spread":"1.49"},{"groupId":"BG003","value":"8.70","spread":"1.45"},{"groupId":"BG004","value":"8.70","spread":"1.46"}]}]}]},{"title":"Fasting plasma glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"185.4","spread":"66.09"},{"groupId":"BG001","value":"182.9","spread":"68.04"},{"groupId":"BG002","value":"185.8","spread":"68.23"},{"groupId":"BG003","value":"184.6","spread":"63.08"},{"groupId":"BG004","value":"184.7","spread":"66.37"}]}]}]},{"title":"Body weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"91.80","spread":"20.25"},{"groupId":"BG001","value":"92.86","spread":"21.05"},{"groupId":"BG002","value":"91.83","spread":"20.35"},{"groupId":"BG003","value":"91.90","spread":"20.75"},{"groupId":"BG004","value":"92.09","spread":"20.60"}]}]}]},{"title":"LDL-cholesterol","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"89.62","spread":"39.08"},{"groupId":"BG001","value":"89.72","spread":"34.49"},{"groupId":"BG002","value":"89.01","spread":"38.35"},{"groupId":"BG003","value":"91.14","spread":"37.90"},{"groupId":"BG004","value":"89.87","spread":"37.49"}]}]}]},{"title":"HDL-cholesterol","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.92","spread":"13.00"},{"groupId":"BG001","value":"44.97","spread":"12.42"},{"groupId":"BG002","value":"45.82","spread":"12.92"},{"groupId":"BG003","value":"44.61","spread":"12.26"},{"groupId":"BG004","value":"45.33","spread":"12.66"}]}]}]},{"title":"Systolic BP","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"136.1","spread":"17.97"},{"groupId":"BG001","value":"135.8","spread":"16.96"},{"groupId":"BG002","value":"135.8","spread":"16.16"},{"groupId":"BG003","value":"134.8","spread":"17.45"},{"groupId":"BG004","value":"135.6","spread":"17.15"}]}]}]},{"title":"Diastolic BP","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"77.10","spread":"9.78"},{"groupId":"BG001","value":"76.88","spread":"10.21"},{"groupId":"BG002","value":"77.54","spread":"9.85"},{"groupId":"BG003","value":"76.66","spread":"10.21"},{"groupId":"BG004","value":"77.05","spread":"10.02"}]}]}]},{"title":"Pulse rate","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"beats/min","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"72.69","spread":"11.22"},{"groupId":"BG001","value":"71.53","spread":"10.86"},{"groupId":"BG002","value":"72.01","spread":"10.62"},{"groupId":"BG003","value":"71.95","spread":"10.92"},{"groupId":"BG004","value":"72.05","spread":"10.91"}]}]}]},{"title":"Total cholesterol","paramType":"GEOMETRIC_MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"165.38","lowerLimit":"65.25","upperLimit":"632.43"},{"groupId":"BG001","value":"164.96","lowerLimit":"79.54","upperLimit":"562.16"},{"groupId":"BG002","value":"164.38","lowerLimit":"70.27","upperLimit":"378.38"},{"groupId":"BG003","value":"165.97","lowerLimit":"64.86","upperLimit":"537.07"},{"groupId":"BG004","value":"165.17","lowerLimit":"64.86","upperLimit":"632.43"}]}]}]},{"title":"Triglycerides","paramType":"GEOMETRIC_MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"163.66","lowerLimit":"27.59","upperLimit":"1913.50"},{"groupId":"BG001","value":"158.93","lowerLimit":"10.68","upperLimit":"3378.44"},{"groupId":"BG002","value":"162.30","lowerLimit":"30.26","upperLimit":"1438.24"},{"groupId":"BG003","value":"163.00","lowerLimit":"35.60","upperLimit":"2435.93"},{"groupId":"BG004","value":"161.96","lowerLimit":"10.68","upperLimit":"3378.44"}]}]}]},{"title":"Free fatty acids","paramType":"GEOMETRIC_MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0.83","lowerLimit":"0.04","upperLimit":"3.82"},{"groupId":"BG001","value":"0.80","lowerLimit":"0.04","upperLimit":"4.20"},{"groupId":"BG002","value":"0.83","lowerLimit":"0.04","upperLimit":"3.34"},{"groupId":"BG003","value":"0.81","lowerLimit":"0.04","upperLimit":"4.22"},{"groupId":"BG004","value":"0.82","lowerLimit":"0.04","upperLimit":"4.22"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke","description":"Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.","populationDescription":"Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Time from randomisation up to end of follow-up (scheduled at week 109)","groups":[{"id":"OG000","title":"Semaglutide","description":"Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Placebo","description":"Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1648"},{"groupId":"OG001","value":"1649"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.6"},{"groupId":"OG001","value":"8.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The primary endpoint was analysed using a stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as fixed factor. Assuming the same population MACE risk for the semaglutide and placebo groups (i.e., the population hazards ratio \\[HR\\] equals 1), a total minimum of 122 events were needed in order to have at least 90% power to ascertain that the upper two-sided 95% confidence limit for the HR was less than 1.8.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority of semaglutide versus placebo was considered to be confirmed if the upper limit of the two-sided 95% CI for the HR was below 1.8 or equivalent if the p-value for the one-sided test of: H0: HR ≥ 1.8 against Ha: HR \\<1.8 was less than 2.5% (or equivalent to 5% for a two-sided test).","pValue":"<0.0001","pValueComment":"The 'p-value' is for the two-sided Wald test of non-inferiority with limit 1.8.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.58","ciUpperLimit":"0.95","estimateComment":"Semaglutide/Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"A post hoc analysis of superiority of semaglutide versus placebo was performed based on the pre-specified Cox proportional hazard analysis using the two-sided Wald test of no difference, with treatment (semaglutide, placebo) as fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0167","pValueComment":"The 'p-value' is for the two-sided Wald test of no difference.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.58","ciUpperLimit":"0.95","estimateComment":"Semaglutide/Placebo"}]},{"type":"SECONDARY","title":"Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome","description":"Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation \\[coronary and peripheral\\], unstable angina requiring hospitalisation or hospitalisation for heart failure)","populationDescription":"Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Time from randomisation up to end of follow-up (scheduled at week 109)","groups":[{"id":"OG000","title":"Semaglutide","description":"Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Placebo","description":"Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1648"},{"groupId":"OG001","value":"1649"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.1"},{"groupId":"OG001","value":"16.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0016","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.62","ciUpperLimit":"0.89","estimateComment":"Semaglutide/Placebo"}]},{"type":"SECONDARY","title":"Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome","description":"Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation \\[coronary and peripheral\\], unstable angina requiring hospitalisation or hospitalisation for heart failure).","populationDescription":"Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Time from randomisation up to end of follow-up (scheduled at week 109)","groups":[{"id":"OG000","title":"Semaglutide","description":"Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Placebo","description":"Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1648"},{"groupId":"OG001","value":"1649"}]}],"classes":[{"title":"Cardiovascular death","categories":[{"measurements":[{"groupId":"OG000","value":"1.6"},{"groupId":"OG001","value":"1.9"}]}]},{"title":"Non-fatal MI","categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"3.7"}]}]},{"title":"Non-fatal Stroke","categories":[{"measurements":[{"groupId":"OG000","value":"1.5"},{"groupId":"OG001","value":"2.5"}]}]},{"title":"Revascularisation","categories":[{"measurements":[{"groupId":"OG000","value":"2.6"},{"groupId":"OG001","value":"4.2"}]}]},{"title":"UAP requiring hospitalisation","categories":[{"measurements":[{"groupId":"OG000","value":"1.1"},{"groupId":"OG001","value":"1.3"}]}]},{"title":"Hospitalisation for heart failure","categories":[{"measurements":[{"groupId":"OG000","value":"2.7"},{"groupId":"OG001","value":"2.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for CV death was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9181","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.65","ciUpperLimit":"1.48","estimateComment":"Semaglutide/Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for non-fatal myocardial infarction was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1194","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.51","ciUpperLimit":"1.08","estimateComment":"Semaglutide/Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0438","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.38","ciUpperLimit":"0.99","estimateComment":"Semaglutide/Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for revascularisation was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0027","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.50","ciUpperLimit":"0.86","estimateComment":"Semaglutide/Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for 'unstable angina requiring hospitalisation' was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4914","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.82","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.47","ciUpperLimit":"1.44","estimateComment":"Semaglutide/Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for hospitalisation for heart failure was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5735","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.77","ciUpperLimit":"1.61","estimateComment":"Semaglutide/Placcbo"}]},{"type":"SECONDARY","title":"Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke","description":"Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.","populationDescription":"Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Time from randomisation up to end of follow-up (scheduled at week 109)","groups":[{"id":"OG000","title":"Semaglutide","description":"Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Placebo","description":"Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1648"},{"groupId":"OG001","value":"1649"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.4"},{"groupId":"OG001","value":"9.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for all-cause death, non-fatal MI or non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0292","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.61","ciUpperLimit":"0.97","estimateComment":"Semaglutide/Placebo"}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)","description":"Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.","populationDescription":"Full analysis set included all the randomised subjects","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of glycosylated haemoglobin","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.09","spread":"0.05"},{"groupId":"OG001","value":"-1.41","spread":"0.05"},{"groupId":"OG002","value":"-0.44","spread":"0.05"},{"groupId":"OG003","value":"-0.36","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.80","ciUpperLimit":"-0.52","estimateComment":"Sema 0.5 mg - Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.19","ciUpperLimit":"-0.91","estimateComment":"Sema 1.0 mg - Placebo 1.0 mg"}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose","description":"Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.","populationDescription":"Full analysis set included all the randomised subjects.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.75","spread":"0.12"},{"groupId":"OG001","value":"-2.11","spread":"0.12"},{"groupId":"OG002","value":"-1.02","spread":"0.12"},{"groupId":"OG003","value":"-0.88","spread":"0.12"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-0.72","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.06","ciUpperLimit":"-0.38","estimateComment":"Sema 0.5 mg - Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.56","ciUpperLimit":"-0.88","estimateComment":"Sema 1.0 mg - Placebo 1.0 mg"}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight","description":"Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.","populationDescription":"Full analysis set included all the randomised subjects. As specified in the protocol, the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo","description":"Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"1649"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.57","spread":"0.21"},{"groupId":"OG001","value":"-4.88","spread":"0.22"},{"groupId":"OG002","value":"-0.62","spread":"0.15"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-2.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.47","ciUpperLimit":"-2.44","estimateComment":"Sema 0.5 mg - Placebo"},{"groupIds":["OG001","OG002"],"groupDescription":"Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-4.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.78","ciUpperLimit":"-3.75","estimateComment":"Semaglutide 1.0 mg - Placebo"}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile","description":"Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).","populationDescription":"Full analysis set included all randomised subjects.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"title":"Total cholesterol (mg/dL)","categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"0.01"},{"groupId":"OG001","value":"0.97","spread":"0.01"},{"groupId":"OG002","value":"1.00","spread":"0.01"},{"groupId":"OG003","value":"0.99","spread":"0.01"}]}]},{"title":"HDL-cholesterol (mg/dL)","categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"0.01"},{"groupId":"OG001","value":"1.01","spread":"0.01"},{"groupId":"OG002","value":"0.99","spread":"0.01"},{"groupId":"OG003","value":"0.97","spread":"0.01"}]}]},{"title":"LDL-cholesterol (mg/dL)","categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"0.01"},{"groupId":"OG001","value":"0.98","spread":"0.01"},{"groupId":"OG002","value":"1.01","spread":"0.01"},{"groupId":"OG003","value":"0.99","spread":"0.01"}]}]},{"title":"Triglycerides (mg/dL)","categories":[{"measurements":[{"groupId":"OG000","value":"0.93","spread":"0.01"},{"groupId":"OG001","value":"0.92","spread":"0.01"},{"groupId":"OG002","value":"0.96","spread":"0.01"},{"groupId":"OG003","value":"0.98","spread":"0.01"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0149","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.95","ciUpperLimit":"1.00","estimateComment":"Semaglutide 0.5 mg/Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2580","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.97","ciUpperLimit":"1.01","estimateComment":"Semaglutide 1.0 mg/Placebo 1.0 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8106","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"1.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.99","ciUpperLimit":"1.02","estimateComment":"Semaglutide 0.5 mg/Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"1.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.02","ciUpperLimit":"1.06","estimateComment":"Semaglutide 1.0 mg/Placebo 1.0 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0185","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.93","ciUpperLimit":"0.99","estimateComment":"Semaglutide 0.5 mg/Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5996","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.96","ciUpperLimit":"1.03","estimateComment":"Semaglutide 1.0 mg/Placebo 1.0 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1833","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.93","ciUpperLimit":"1.01","estimateComment":"Semaglutide 0.5 mg/Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0009","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.93","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.89","ciUpperLimit":"0.97","estimateComment":"Semaglutide 1.0 mg/Placebo 1.0 mg"}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio","description":"Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.","populationDescription":"Full analysis set included all the randomised subjects","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/g","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"0.05"},{"groupId":"OG001","value":"0.91","spread":"0.05"},{"groupId":"OG002","value":"1.32","spread":"0.07"},{"groupId":"OG003","value":"1.29","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0003","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.68","ciUpperLimit":"0.89","estimateComment":"Sema 0.5 mg / Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.71","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.62","ciUpperLimit":"0.81","estimateComment":"Sema 1.0 mg / Placebo 1.0 mg"}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs","description":"Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).","populationDescription":"Full analysis set included all the randomised subjects.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"title":"Diastolic blood pressure (mmHg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.37","spread":"0.32"},{"groupId":"OG001","value":"-1.57","spread":"0.32"},{"groupId":"OG002","value":"-1.42","spread":"0.32"},{"groupId":"OG003","value":"-1.71","spread":"0.32"}]}]},{"title":"Systolic blood pressure (mmHg)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.44","spread":"0.54"},{"groupId":"OG001","value":"-5.37","spread":"0.54"},{"groupId":"OG002","value":"-2.17","spread":"0.54"},{"groupId":"OG003","value":"-2.78","spread":"0.54"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9205","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.83","ciUpperLimit":"0.92","estimateComment":"Semaglutide 0.5 mg - Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7477","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.74","ciUpperLimit":"1.03","estimateComment":"Semaglutide 1.0 mg - Placebo 1.0 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0976","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.77","ciUpperLimit":"0.23","estimateComment":"Semaglutide 0.5 mg - Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0008","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-2.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.09","ciUpperLimit":"-1.08","estimateComment":"Semaglutide 1.0 mg - Placebo 1.0 mg"}]},{"type":"SECONDARY","title":"Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events","description":"Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.","populationDescription":"Full analysis set included all randomised subjects.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Event rate per 100 exposure years","timeFrame":"Week 0 - 109","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.5"},{"groupId":"OG001","value":"36.2"},{"groupId":"OG002","value":"35.3"},{"groupId":"OG003","value":"39.7"}]}]}]},{"type":"SECONDARY","title":"Incidence During the Trial in Other Treatment Outcomes: Adverse Events","description":"Rates (event rate per 100 years of exposure) of treatment emergent adverse events.","populationDescription":"Full analysis set included all randomised subjects.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Event rate per 100 years of exposure","timeFrame":"Weeks 0-109","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"330.5"},{"groupId":"OG001","value":"337.0"},{"groupId":"OG002","value":"317.4"},{"groupId":"OG003","value":"298.3"}]}]}]},{"type":"SECONDARY","title":"Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies","description":"The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.","populationDescription":"Full analysis set included all randomised subjects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of subjects","timeFrame":"Weeks 0-109","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.4"},{"groupId":"OG001","value":"2.3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)","description":"Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.","populationDescription":"Full analysis set included all randomised subjects.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Scores on a scale","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"title":"Bodily pain","categories":[{"measurements":[{"groupId":"OG000","value":"0.66","spread":"0.35"},{"groupId":"OG001","value":"1.82","spread":"0.35"},{"groupId":"OG002","value":"0.16","spread":"0.35"},{"groupId":"OG003","value":"0.35","spread":"0.35"}]}]},{"title":"General health","categories":[{"measurements":[{"groupId":"OG000","value":"1.66","spread":"0.29"},{"groupId":"OG001","value":"2.55","spread":"0.29"},{"groupId":"OG002","value":"0.78","spread":"0.29"},{"groupId":"OG003","value":"1.13","spread":"0.30"}]}]},{"title":"Mental component summary","categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.35"},{"groupId":"OG001","value":"0.86","spread":"0.35"},{"groupId":"OG002","value":"-0.17","spread":"0.35"},{"groupId":"OG003","value":"-0.11","spread":"0.35"}]}]},{"title":"Mental health","categories":[{"measurements":[{"groupId":"OG000","value":"0.48","spread":"0.33"},{"groupId":"OG001","value":"1.08","spread":"0.33"},{"groupId":"OG002","value":"-0.14","spread":"0.33"},{"groupId":"OG003","value":"-0.31","spread":"0.33"}]}]},{"title":"Physical component summary","categories":[{"measurements":[{"groupId":"OG000","value":"0.76","spread":"0.28"},{"groupId":"OG001","value":"1.74","spread":"0.28"},{"groupId":"OG002","value":"0.07","spread":"0.28"},{"groupId":"OG003","value":"0.35","spread":"0.28"}]}]},{"title":"Physical functioning","categories":[{"measurements":[{"groupId":"OG000","value":"0.42","spread":"0.32"},{"groupId":"OG001","value":"1.12","spread":"0.32"},{"groupId":"OG002","value":"-0.38","spread":"0.32"},{"groupId":"OG003","value":"-0.37","spread":"0.33"}]}]},{"title":"Role-emotional","categories":[{"measurements":[{"groupId":"OG000","value":"0.17","spread":"0.42"},{"groupId":"OG001","value":"0.89","spread":"0.42"},{"groupId":"OG002","value":"-0.36","spread":"0.42"},{"groupId":"OG003","value":"-0.05","spread":"0.42"}]}]},{"title":"Role-physical","categories":[{"measurements":[{"groupId":"OG000","value":"0.39","spread":"0.34"},{"groupId":"OG001","value":"1.18","spread":"0.35"},{"groupId":"OG002","value":"-0.33","spread":"0.35"},{"groupId":"OG003","value":"0.03","spread":"0.35"}]}]},{"title":"Social functioning","categories":[{"measurements":[{"groupId":"OG000","value":"-0.25","spread":"0.35"},{"groupId":"OG001","value":"0.97","spread":"0.35"},{"groupId":"OG002","value":"-0.20","spread":"0.36"},{"groupId":"OG003","value":"-0.17","spread":"0.36"}]}]},{"title":"Vitality","categories":[{"measurements":[{"groupId":"OG000","value":"0.29","spread":"0.31"},{"groupId":"OG001","value":"1.55","spread":"0.31"},{"groupId":"OG002","value":"-0.04","spread":"0.31"},{"groupId":"OG003","value":"0.35","spread":"0.31"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3171","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"0.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.48","ciUpperLimit":"1.47","estimateComment":"Semaglutide 0.5 mg - 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Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1136","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"0.94","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.22","ciUpperLimit":"2.10","estimateComment":"Semaglutide 1.0 mg - Placebo 1.0 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1431","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"0.72","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"1.67","estimateComment":"Semaglutide 0.5 mg - 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Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0064","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"1.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.34","ciUpperLimit":"2.07","estimateComment":"Semaglutide 1.0 mg - Placebo 1.0 mg"}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)","description":"Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).","populationDescription":"Full analysis set included all randomised subjects.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG002","title":"Placebo 0.5 mg","description":"Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks."},{"id":"OG003","title":"Placebo 1.0 mg","description":"Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"826"},{"groupId":"OG001","value":"822"},{"groupId":"OG002","value":"824"},{"groupId":"OG003","value":"825"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"0.02"},{"groupId":"OG001","value":"0.91","spread":"0.01"},{"groupId":"OG002","value":"0.96","spread":"0.02"},{"groupId":"OG003","value":"0.99","spread":"0.02"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7796","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.95","ciUpperLimit":"1.04","estimateComment":"Semaglutide 0.5 mg/Placebo 0.5 mg"},{"groupIds":["OG001","OG003"],"groupDescription":"Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0003","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment ratio","paramValue":"0.92","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.88","ciUpperLimit":"0.96","estimateComment":"Semaglutide 1.0 mg/Placebo 1.0 mg"}]},{"type":"SECONDARY","title":"Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)","description":"Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).","populationDescription":"Full analysis set included all the randomised subjects.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats/min","timeFrame":"Week 0, up to week 104","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. 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