{"protocolSection":{"identificationModule":{"nctId":"NCT02692716","orgStudyIdInfo":{"id":"NN9924-4221"},"secondaryIdInfos":[{"id":"2015-003563-10","type":"EUDRACT_NUMBER"},{"id":"U1111-1173-0750","type":"OTHER","domain":"WHO"},{"id":"NL56580.091.16","type":"OTHER","domain":"CCMO"},{"id":"2015","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2015"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes","officialTitle":"A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes","acronym":"PIONEER 6"},"statusModule":{"statusVerifiedDate":"2022-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-01-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-09-25","type":"ACTUAL"},"completionDateStruct":{"date":"2018-09-25","type":"ACTUAL"},"studyFirstSubmitDate":"2016-02-23","studyFirstSubmitQcDate":"2016-02-23","studyFirstPostDateStruct":{"date":"2016-02-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-10-15","resultsFirstSubmitQcDate":"2020-02-14","resultsFirstPostDateStruct":{"date":"2020-02-27","type":"ACTUAL"},"dispFirstSubmitDate":"2019-06-18","dispFirstSubmitQcDate":"2019-06-18","dispFirstPostDateStruct":{"date":"2019-06-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-07-11","lastUpdatePostDateStruct":{"date":"2022-07-20","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 investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes."},"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":3183,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Oral semaglutide","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"For oral use once daily.","armGroupLabels":["Oral semaglutide"]},{"type":"DRUG","name":"placebo","description":"For oral use once daily.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke","description":"Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period."}],"secondaryOutcomes":[{"measure":"Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure","description":"Participants experiencing first occurrence of an expanded composite CV endpoint \\[defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, UAP (unstable angina pectoris) requiring hospitalisation or heart failure requiring hospitalisation\\] are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period."},{"measure":"Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint","description":"Participants experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or heart failure requiring hospitalisation) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period."},{"measure":"Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke","description":"Participants experiencing first occurrence of a composite CV endpoint (defined as all-cause death, non-fatal myocardial infarction or nonfatal stroke) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period."},{"measure":"Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction","description":"Number of participants experiencing a first event of a fatal or non-fatal myocardial infarction are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period."},{"measure":"Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke","description":"Number of participants experiencing a first event of a fatal or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period."},{"measure":"Time From Randomisation to All-cause Death","description":"Number of all-cause deaths in the study are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period."},{"measure":"Time to First AE Leading to Permanent Trial Product Discontinuation","description":"Number of participants who permanently discontinued trial product in ths study are presented. Results are based on the on-treatment observation period which starts at the date of first dose on trial product; ends on last date on trial product +38 days (ascertainment window).","timeFrame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window."},{"measure":"Number of Serious Adverse Events","description":"Number of serious adverse events were recorded from week 0 to week 87 in the study. Results are based on the on-treatment observation period which started at the date of first dose on trial product and ended on last date on trial product +38 days (ascertainment window).","timeFrame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window."},{"measure":"Change in Eye Examination Category","description":"Participants with eye examination findings, normal, abnormal non clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -3) and end of treatment visit (week 83) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Week -3, End of treatment"},{"measure":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).","timeFrame":"Week 0, End of treatment"},{"measure":"Change in Systolic and Diastolic Blood Pressure","description":"Change from baseline (week 0) in systolic and diastolic blood pressure measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).","timeFrame":"Week 0, End of treatment"},{"measure":"Change in Glycosylated Haemoglobin (HbA1c)","description":"Change from baseline (week 0) in HbA1c measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Week 0, End of treatment"},{"measure":"Change in Body Weight","description":"Change from baseline (week 0) in body weight measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Week 0, End of treatment"},{"measure":"Change in Total Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at the end of treatment (week 83) visit is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Week 0, End of treatment"},{"measure":"Change in LDL-cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in LDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Week 0, End of treatment"},{"measure":"Change in HDL-cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in HDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Week 0, End of treatment"},{"measure":"Change in Triglycerides - Ratio to Baseline","description":"Change from baseline (week 0) in triglycerides (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","timeFrame":"Week 0, End of treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female diagnosed with type 2 diabetes\n* Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor\n\nExclusion Criteria:\n\n* Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide\n* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)\n* History of pancreatitis (acute or chronic)\n* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)\n* Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure\n* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\n* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening\n* Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m\\^2)\n* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)","healthyVolunteers":false,"sex":"ALL","minimumAge":"50 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global 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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":"35373893","type":"RESULT","citation":"Aroda VR, Bauer R, Christiansen E, Haluzik M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9."},{"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":"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":"32267058","type":"DERIVED","citation":"Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13."},{"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."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Data presented in \"participant flow\" is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","recruitmentDetails":"The study was conducted at 214 sites in 21 countries: Algeria (4), Argentina (6), Brazil (1), Canada (7), Denmark (5), Germany (10), India (16), Israel (8), Italy (7), Malaysia (10), Mexico (6), Netherlands (5), Poland (5), Romania (8), South Africa (9), Spain (9), Taiwan (4), Thailand (7), Turkey (9) and United Kingdom (9), United Stated (69).","groups":[{"id":"FG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"FG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1591"},{"groupId":"FG001","numSubjects":"1592"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"1591"},{"groupId":"FG001","numSubjects":"1592"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"1591"},{"groupId":"FG001","numSubjects":"1591"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1586"},{"groupId":"FG001","numSubjects":"1586"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"BG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1591"},{"groupId":"BG001","value":"1592"},{"groupId":"BG002","value":"3183"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"66","spread":"7"},{"groupId":"BG001","value":"66","spread":"7"},{"groupId":"BG002","value":"66","spread":"7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"507"},{"groupId":"BG001","value":"500"},{"groupId":"BG002","value":"1007"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1084"},{"groupId":"BG001","value":"1092"},{"groupId":"BG002","value":"2176"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"253"},{"groupId":"BG001","value":"261"},{"groupId":"BG002","value":"514"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1338"},{"groupId":"BG001","value":"1331"},{"groupId":"BG002","value":"2669"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"1148"},{"groupId":"BG001","value":"1152"},{"groupId":"BG002","value":"2300"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"89"},{"groupId":"BG001","value":"103"},{"groupId":"BG002","value":"192"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"324"},{"groupId":"BG001","value":"306"},{"groupId":"BG002","value":"630"}]},{"title":"American Indian or Alaska native","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"29"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"26"}]}]}]},{"title":"Baseline cardiovasular disease (CVD)/chronic kidney disease (CKD) risk details","description":"This table describes the baseline details of subjects in the study with the risk of CVD and/or CKD.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Established CVD and/or CKD, age ≥ 50 years","categories":[{"measurements":[{"groupId":"BG000","value":"1350"},{"groupId":"BG001","value":"1345"},{"groupId":"BG002","value":"2695"}]}]},{"title":"Evidence of CV risk factors, age ≥ 60 years","categories":[{"measurements":[{"groupId":"BG000","value":"241"},{"groupId":"BG001","value":"247"},{"groupId":"BG002","value":"488"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke","description":"Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"76"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first event adjudication committee (EAC) confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"This hypothesis was controlled for multiplicity. Non-inferiority of oral semaglutide versus placebo was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was strictly below 1.8.","pValue":"< 0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority).","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.57","ciUpperLimit":"1.11"},{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was controlled for multiplicity.","pValue":"= 0.1749","pValueComment":"Unadjusted two-sided p-value from test of no difference from 1 (superiority).","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.57","ciUpperLimit":"1.11"}]},{"type":"SECONDARY","title":"Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure","description":"Participants experiencing first occurrence of an expanded composite CV endpoint \\[defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, UAP (unstable angina pectoris) requiring hospitalisation or heart failure requiring hospitalisation\\] are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"100"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed expanded cardiovascular outcome was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"= 0.1827","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.82","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.61","ciUpperLimit":"1.10"}]},{"type":"SECONDARY","title":"Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint","description":"Participants experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or heart failure requiring hospitalisation) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"title":"Cardiovascular death","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"30"}]}]},{"title":"Non-fatal myocardial infarction","categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"31"}]}]},{"title":"Non-fatal stroke","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"16"}]}]},{"title":"Unstable angina requiring hospitalisation","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"7"}]}]},{"title":"Heart failure requiring hospitalisation","categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"24"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed cardiovascular death (including undetermined cause of death) was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"= 0.0261","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.27","ciUpperLimit":"0.92"},{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"= 0.5044","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.73","ciUpperLimit":"1.90"},{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"= 0.4350","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.35","ciUpperLimit":"1.57"},{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed unstable angina pectoris requiring hospitalisation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"= 0.3605","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.60","ciUpperLimit":"4.01"},{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed hospitalisation for heart failure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"= 0.6227","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.48","ciUpperLimit":"1.55"}]},{"type":"SECONDARY","title":"Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke","description":"Participants experiencing first occurrence of a composite CV endpoint (defined as all-cause death, non-fatal myocardial infarction or nonfatal stroke) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"89"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death, non-fatal myocardial infarction or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"= 0.0952","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.56","ciUpperLimit":"1.05"}]},{"type":"SECONDARY","title":"Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction","description":"Number of participants experiencing a first event of a fatal or non-fatal myocardial infarction are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"35"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from the on-treatment observation period. Time from first dose of trial product to first EAC-confirmed fatal or non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their on-treatment observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"0.8583","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.66","ciUpperLimit":"1.66"}]},{"type":"SECONDARY","title":"Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke","description":"Number of participants experiencing a first event of a fatal or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"17"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed fatal or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"0.4485","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.37","ciUpperLimit":"1.56"}]},{"type":"SECONDARY","title":"Time From Randomisation to All-cause Death","description":"Number of all-cause deaths in the study are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"45"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"0.0078","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.31","ciUpperLimit":"0.84"}]},{"type":"SECONDARY","title":"Time to First AE Leading to Permanent Trial Product Discontinuation","description":"Number of participants who permanently discontinued trial product in ths study are presented. Results are based on the on-treatment observation period which starts at the date of first dose on trial product; ends on last date on trial product +38 days (ascertainment window).","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"104"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from date of first dose of trial product to date of end of treatment visit. Time from first dose to first AE leading to permanent trial product discontinuation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the date of their end of treatment visit or at their end of study date, whichever came first.","nonInferiorityType":"OTHER","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.42","ciUpperLimit":"2.30"}]},{"type":"SECONDARY","title":"Number of Serious Adverse Events","description":"Number of serious adverse events were recorded from week 0 to week 87 in the study. Results are based on the on-treatment observation period which started at the date of first dose on trial product and ended on last date on trial product +38 days (ascertainment window).","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"545"},{"groupId":"OG001","value":"618"}]}]}]},{"type":"SECONDARY","title":"Change in Eye Examination Category","description":"Participants with eye examination findings, normal, abnormal non clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -3) and end of treatment visit (week 83) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -3, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1592"}]}],"classes":[{"title":"Left eye fundoscopy (week -3): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1590"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"848"},{"groupId":"OG001","value":"843"}]}]},{"title":"Left eye fundoscopy (week -3): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1590"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"657"},{"groupId":"OG001","value":"673"}]}]},{"title":"Left eye fundoscopy (week -3): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1591"},{"groupId":"OG001","value":"1590"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"74"}]}]},{"title":"Right eye fundoscopy (week -3): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1590"},{"groupId":"OG001","value":"1591"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"845"},{"groupId":"OG001","value":"858"}]}]},{"title":"Right eye fundoscopy (week -3): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1590"},{"groupId":"OG001","value":"1591"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"659"},{"groupId":"OG001","value":"661"}]}]},{"title":"Right eye fundoscopy (week -3): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1590"},{"groupId":"OG001","value":"1591"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"72"}]}]},{"title":"Left eye fundoscopy (EOT): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1465"},{"groupId":"OG001","value":"1449"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"783"},{"groupId":"OG001","value":"790"}]}]},{"title":"Left eye fundoscopy (EOT): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1465"},{"groupId":"OG001","value":"1449"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"599"},{"groupId":"OG001","value":"597"}]}]},{"title":"Left eye fundoscopy (EOT): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1465"},{"groupId":"OG001","value":"1449"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"62"}]}]},{"title":"Right eye fundoscopy (EOT): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1462"},{"groupId":"OG001","value":"1450"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"780"},{"groupId":"OG001","value":"787"}]}]},{"title":"Right eye fundoscopy (EOT): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1462"},{"groupId":"OG001","value":"1450"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"601"},{"groupId":"OG001","value":"599"}]}]},{"title":"Right eye fundoscopy (EOT): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1462"},{"groupId":"OG001","value":"1450"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"64"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats/minute","timeFrame":"Week 0, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1345"},{"groupId":"OG001","value":"1411"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4","spread":"11"},{"groupId":"OG001","value":"-0","spread":"11"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic and Diastolic Blood Pressure","description":"Change from baseline (week 0) in systolic and diastolic blood pressure measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 0, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1345"},{"groupId":"OG001","value":"1411"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-5","spread":"18"},{"groupId":"OG001","value":"-2","spread":"18"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"11"},{"groupId":"OG001","value":"-2","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Glycosylated Haemoglobin (HbA1c)","description":"Change from baseline (week 0) in HbA1c measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1489"},{"groupId":"OG001","value":"1473"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"1.4"},{"groupId":"OG001","value":"-0.3","spread":"1.3"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change from baseline (week 0) in body weight measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Week 0, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1510"},{"groupId":"OG001","value":"1493"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"5.7"},{"groupId":"OG001","value":"-0.8","spread":"4.5"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at the end of treatment (week 83) visit is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Week 0, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1472"},{"groupId":"OG001","value":"1469"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"21.9"},{"groupId":"OG001","value":"0.98","spread":"21.1"}]}]}]},{"type":"SECONDARY","title":"Change in LDL-cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in LDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL-cholesterol","timeFrame":"Week 0, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1466"},{"groupId":"OG001","value":"1467"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"36.6"},{"groupId":"OG001","value":"0.97","spread":"34.5"}]}]}]},{"type":"SECONDARY","title":"Change in HDL-cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in HDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL-cholesterol","timeFrame":"Week 0, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1468"},{"groupId":"OG001","value":"1467"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"16.9"},{"groupId":"OG001","value":"1.02","spread":"15.9"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides - Ratio to Baseline","description":"Change from baseline (week 0) in triglycerides (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Week 0, End of treatment","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1468"},{"groupId":"OG001","value":"1467"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"41.8"},{"groupId":"OG001","value":"0.97","spread":"39.8"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","description":"Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.","eventGroups":[{"id":"EG000","title":"Oral Semaglutide","description":"Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.","deathsNumAffected":23,"deathsNumAtRisk":1591,"seriousNumAffected":301,"seriousNumAtRisk":1591,"otherNumAffected":0,"otherNumAtRisk":1591},{"id":"EG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.","deathsNumAffected":45,"deathsNumAtRisk":1591,"seriousNumAffected":358,"seriousNumAtRisk":1591,"otherNumAffected":0,"otherNumAtRisk":1591}],"seriousEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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