{"protocolSection":{"identificationModule":{"nctId":"NCT02054897","orgStudyIdInfo":{"id":"NN9535-3623"},"secondaryIdInfos":[{"id":"2013-000632-94","type":"EUDRACT_NUMBER"},{"id":"U1111-1139-3090","type":"OTHER","domain":"WHO"},{"id":"JapicCTI-142442","type":"REGISTRY","domain":"JAPIC"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes","acronym":"SUSTAIN™1"},"statusModule":{"statusVerifiedDate":"2019-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-02-03","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-05-08","type":"ACTUAL"},"completionDateStruct":{"date":"2015-05-08","type":"ACTUAL"},"studyFirstSubmitDate":"2014-02-03","studyFirstSubmitQcDate":"2014-02-03","studyFirstPostDateStruct":{"date":"2014-02-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-12-22","resultsFirstSubmitQcDate":"2017-12-22","resultsFirstPostDateStruct":{"date":"2018-01-23","type":"ACTUAL"},"dispFirstSubmitDate":"2016-03-17","dispFirstSubmitQcDate":"2016-03-17","dispFirstPostDateStruct":{"date":"2016-04-15","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-05-28","lastUpdatePostDateStruct":{"date":"2019-06-12","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted globally. 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United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. 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Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23."},{"pmid":"30938762","type":"BACKGROUND","citation":"Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685."},{"pmid":"30865526","type":"BACKGROUND","citation":"Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13."},{"pmid":"28110911","type":"RESULT","citation":"Sorli C, Harashima SI, Tsoukas GM, Unger J, Karsbol JD, Hansen T, Bain SC. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017 Apr;5(4):251-260. doi: 10.1016/S2213-8587(17)30013-X. Epub 2017 Jan 17."},{"pmid":"29687620","type":"RESULT","citation":"Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7."},{"pmid":"29748996","type":"RESULT","citation":"Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15."},{"pmid":"29766634","type":"RESULT","citation":"Ahren B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12."},{"pmid":"29862621","type":"RESULT","citation":"DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9."},{"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":"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":"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."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Out of 87 sites, selected for recruitment, 72 sites in 8 countries randomised subjects: Canada: 7 sites; Italy: 6 sites; Japan: 5 sites; Mexico: 2 sites; Russian Federation: 8 sites; South Africa: 8 sites; United Kingdom: 4 sites; United States: 32 sites.","groups":[{"id":"FG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly subcutaneous (s.c.; under the skin) injections for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period."},{"id":"FG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"FG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"129"},{"groupId":"FG001","numSubjects":"130"},{"groupId":"FG002","numSubjects":"129"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"128"},{"groupId":"FG001","numSubjects":"130"},{"groupId":"FG002","numSubjects":"129"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"119"},{"groupId":"FG001","numSubjects":"123"},{"groupId":"FG002","numSubjects":"117"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"12"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Missing follow-up information","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"7"}]},{"type":"Randomized but not exposed","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide (s.c.) or placebo.","groups":[{"id":"BG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period."},{"id":"BG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"BG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"130"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"387"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"130"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"387"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"54.6","spread":"11.1"},{"groupId":"BG001","value":"52.7","spread":"11.9"},{"groupId":"BG002","value":"53.9","spread":"11.0"},{"groupId":"BG003","value":"53.7","spread":"11.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"130"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"387"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"68"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"59"},{"groupId":"BG003","value":"177"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"60"},{"groupId":"BG001","value":"80"},{"groupId":"BG002","value":"70"},{"groupId":"BG003","value":"210"}]}]}]},{"title":"Glycosylated haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of HbA1c","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"130"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"387"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.09","spread":"0.89"},{"groupId":"BG001","value":"8.12","spread":"0.81"},{"groupId":"BG002","value":"7.95","spread":"0.85"},{"groupId":"BG003","value":"8.05","spread":"0.85"}]}]}]},{"title":"Fasting plasma glucose","populationDescription":"Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"125"},{"groupId":"BG001","value":"129"},{"groupId":"BG002","value":"127"},{"groupId":"BG003","value":"381"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"9.66","spread":"2.77"},{"groupId":"BG001","value":"9.90","spread":"2.50"},{"groupId":"BG002","value":"9.68","spread":"2.77"},{"groupId":"BG003","value":"9.75","spread":"2.67"}]}]}]},{"title":"Body weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilogram(s)","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"130"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"387"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"89.81","spread":"22.96"},{"groupId":"BG001","value":"96.87","spread":"25.59"},{"groupId":"BG002","value":"89.05","spread":"22.16"},{"groupId":"BG003","value":"91.93","spread":"23.83"}]}]}]},{"title":"Diastolic blood pressure","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"130"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"387"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"79.52","spread":"9.06"},{"groupId":"BG001","value":"79.25","spread":"8.52"},{"groupId":"BG002","value":"79.14","spread":"8.39"},{"groupId":"BG003","value":"79.30","spread":"8.64"}]}]}]},{"title":"Systolic blood pressure","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"130"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"387"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"127.87","spread":"13.15"},{"groupId":"BG001","value":"128.89","spread":"12.92"},{"groupId":"BG002","value":"129.57","spread":"13.50"},{"groupId":"BG003","value":"128.78","spread":"13.18"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c (Glycosylated Haemoglobin)","description":"Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"OG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"129"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.47","spread":"1.02"},{"groupId":"OG001","value":"-1.56","spread":"1.26"},{"groupId":"OG002","value":"-0.00","spread":"0.90"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 0%.","pValue":"< 0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.81","ciUpperLimit":"-1.25","estimateComment":"Semaglutide 1.0 mg minus Placebo"},{"groupIds":["OG000","OG002"],"groupDescription":"For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.","pValue":"< 0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.71","ciUpperLimit":"-1.15","estimateComment":"Semaglutide 0.5 mg minus Placebo"}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram(s)","timeFrame":"Week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"OG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"129"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.68","spread":"4.03"},{"groupId":"OG001","value":"-4.67","spread":"5.19"},{"groupId":"OG002","value":"-0.89","spread":"3.46"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.","populationDescription":"Full analysis set. Number of subject analysed=subjects who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"OG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"129"},{"groupId":"OG002","value":"127"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.41","spread":"2.55"},{"groupId":"OG001","value":"-2.39","spread":"2.74"},{"groupId":"OG002","value":"-0.55","spread":"2.2"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic and Diastolic Blood Pressure","description":"Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"OG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"129"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-2.29","spread":"12.58"},{"groupId":"OG001","value":"-2.74","spread":"11.58"},{"groupId":"OG002","value":"-2.01","spread":"11.23"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-0.73","spread":"6.88"},{"groupId":"OG001","value":"0.22","spread":"7.6"},{"groupId":"OG002","value":"0.60","spread":"7.59"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target","description":"Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of subjects","timeFrame":"At 30 weeks of treatment","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"OG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"129"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"74.2"},{"groupId":"OG001","value":"72.3"},{"groupId":"OG002","value":"24.8"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"25.8"},{"groupId":"OG001","value":"27.7"},{"groupId":"OG002","value":"75.2"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target","description":"Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of subjects","timeFrame":"At 30 weeks of treatment","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period."},{"id":"OG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"129"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"59.4"},{"groupId":"OG001","value":"60.0"},{"groupId":"OG002","value":"13.2"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"40.6"},{"groupId":"OG001","value":"40.0"},{"groupId":"OG002","value":"86.8"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)","description":"Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.","eventGroups":[{"id":"EG000","title":"Semaglutide 0.5 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.","seriousNumAffected":7,"seriousNumAtRisk":128,"otherNumAffected":53,"otherNumAtRisk":128},{"id":"EG001","title":"Semaglutide 1.0 mg","description":"Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.","seriousNumAffected":7,"seriousNumAtRisk":130,"otherNumAffected":47,"otherNumAtRisk":130},{"id":"EG002","title":"Placebo","description":"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.\n\n1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.\n2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.","seriousNumAffected":5,"seriousNumAtRisk":129,"otherNumAffected":27,"otherNumAtRisk":129}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":128},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":130},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":129}]},{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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