{"protocolSection":{"identificationModule":{"nctId":"NCT02305381","orgStudyIdInfo":{"id":"NN9535-3627"},"secondaryIdInfos":[{"id":"2013-004502-26","type":"EUDRACT_NUMBER"},{"id":"U1111-1149-3738","type":"OTHER","domain":"WHO"},{"id":"JapicCTI-142729","type":"OTHER","domain":"JAPIC"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes","acronym":"SUSTAIN™ 5"},"statusModule":{"statusVerifiedDate":"2019-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-12-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-11-21","type":"ACTUAL"},"completionDateStruct":{"date":"2015-11-21","type":"ACTUAL"},"studyFirstSubmitDate":"2014-11-28","studyFirstSubmitQcDate":"2014-11-28","studyFirstPostDateStruct":{"date":"2014-12-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-12-14","resultsFirstSubmitQcDate":"2018-02-15","resultsFirstPostDateStruct":{"date":"2018-02-19","type":"ACTUAL"},"dispFirstSubmitDate":"2016-11-15","dispFirstSubmitQcDate":"2016-11-15","dispFirstPostDateStruct":{"date":"2016-11-16","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-05-28","lastUpdatePostDateStruct":{"date":"2019-06-11","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin 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":397,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 0.5 mg/Week","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Semaglutide 1.0 mg/Week","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Semaglutide Placebo 0.5 mg/Week","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]},{"label":"Semaglutide Placebo 1.0 mg/Week","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.","armGroupLabels":["Semaglutide 0.5 mg/Week","Semaglutide 1.0 mg/Week"]},{"type":"DRUG","name":"placebo","description":"Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.","armGroupLabels":["Semaglutide Placebo 0.5 mg/Week","Semaglutide Placebo 1.0 mg/Week"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c (Glycosylated Haemoglobin)","description":"Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.","timeFrame":"Week 0, week 30"}],"secondaryOutcomes":[{"measure":"Change in Body Weight","description":"Estimated mean change from baseline in body weight at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.","timeFrame":"Week 0, week 30"},{"measure":"Change in Fasting Plasma Glucose (FPG)","description":"Estimated mean change from baseline in FPG at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.","timeFrame":"week 0, week 30"},{"measure":"Change in Insulin Dose","description":"Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. Responses at week 30 are analysed using an Analysis of covariance model with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.","timeFrame":"week 0, week 30"},{"measure":"Change in Systolic and Diastolic Blood Pressure","description":"Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.","timeFrame":"week 0, week 30"},{"measure":"Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)","description":"The DTSQs questionnaire was used to assess subjects' treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] and use of metformin \\[yes or no\\]) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.","timeFrame":"week 0, week 30"},{"measure":"HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target","description":"Percentage of subjects with HbA1C below 7.0% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.","timeFrame":"After 30 weeks treatment"},{"measure":"HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target","description":"Percentage of participants with HbA1c below or equal to 6.5% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.","timeFrame":"After 30 weeks treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria: - Male or female, age at least 18 years at the time of signing inform consent. For Japan: Male or female, age at least 20 years at the time of signing informed consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin) 7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with bolus insulin in connection with intercurrent illness - Experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness - History of pancreatitis (acute or chronic) - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome 2 (MEN 2) - Severe renal impairment defined as eGFR (estimated glomerular filtration rate) below 30 mL/min/1.73 m\\^2 per Modification of Diet in Renal Disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) Class IV","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 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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."},{"type":"RESULT","citation":"Rodbard H, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu P-L, Wijayasinghe N, Norwood P. Efficacy and safety of semaglutide once-weekly vs placebo as add-on to basal insulin alone or in combination with metformin in subjects with type 2 diabetes (SUSTAIN 5). Diabetologia. 2016; 59: S364-5."},{"pmid":"29688502","type":"RESULT","citation":"Rodbard HW, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu PL, Wijayasinghe N, Norwood P. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2291-2301. doi: 10.1210/jc.2018-00070."},{"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":"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":"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."},{"pmid":"31215727","type":"DERIVED","citation":"Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"The trial was conducted at 90 sites in 5 countries, as follows: Germany: 10 sites; Japan: 6 sites; Serbia: 4 sites; Slovakia: 5 sites; United States: 65.","groups":[{"id":"FG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg subcutaneous (sc) injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"FG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30.Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"FG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"132"},{"groupId":"FG001","numSubjects":"132"},{"groupId":"FG002","numSubjects":"133"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"132"},{"groupId":"FG001","numSubjects":"131"},{"groupId":"FG002","numSubjects":"133"}]},{"type":"Premature Discontinuation of Treatment","achievements":[{"groupId":"FG000","comment":"Subjects who prematurely discontinued treatment were allowed to continue participation in the trial.","numSubjects":"14"},{"groupId":"FG001","comment":"Subjects who prematurely discontinued treatment were allowed to continue participation in the trial","numSubjects":"16"},{"groupId":"FG002","comment":"Subjects who prematurely discontinued treatment were allowed to continue participation in the trial.","numSubjects":"13"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Subjects who completed the trial.","numSubjects":"127"},{"groupId":"FG001","comment":"Subjects who completed the trial.","numSubjects":"127"},{"groupId":"FG002","comment":"Subjects who completed the trial.","numSubjects":"126"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"7"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Analysis was performed on full analysis set which included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.","groups":[{"id":"BG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"BG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"BG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"59.1","spread":"10.3"},{"groupId":"BG001","value":"58.5","spread":"9.0"},{"groupId":"BG002","value":"58.8","spread":"10.9"},{"groupId":"BG003","value":"58.8","spread":"10.1"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Adults (18-64 years)","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"93"},{"groupId":"BG001","value":"102"},{"groupId":"BG002","value":"86"},{"groupId":"BG003","value":"281"}]}]},{"title":"From 65-84 years","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"46"},{"groupId":"BG003","value":"114"}]}]},{"title":"85 years and over","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"62"},{"groupId":"BG003","value":"174"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"74"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"71"},{"groupId":"BG003","value":"222"}]}]}]},{"title":"Glycosylated haemoglobin","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated haemoglobin","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.36","spread":"0.83"},{"groupId":"BG001","value":"8.31","spread":"0.82"},{"groupId":"BG002","value":"8.42","spread":"0.88"},{"groupId":"BG003","value":"8.37","spread":"0.84"}]}]}]},{"title":"Body weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"92.74","spread":"19.57"},{"groupId":"BG001","value":"92.49","spread":"22.23"},{"groupId":"BG002","value":"89.88","spread":"21.06"},{"groupId":"BG003","value":"91.70","spread":"20.97"}]}]}]},{"title":"Fasting plasma glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"161.0","spread":"62.38"},{"groupId":"BG001","value":"152.5","spread":"50.91"},{"groupId":"BG002","value":"154.1","spread":"46.66"},{"groupId":"BG003","value":"155.9","spread":"53.68"}]}]}]},{"title":"Insulin dose","populationDescription":"Number of participants analysed=participants with available data for insulin dose at baseline.","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"international unit","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"131"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"395"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"35.00","lowerLimit":"15.00","upperLimit":"300.00"},{"groupId":"BG001","value":"36.00","lowerLimit":"14.00","upperLimit":"320.00"},{"groupId":"BG002","value":"36.00","lowerLimit":"12.00","upperLimit":"124.00"},{"groupId":"BG003","value":"36.00","lowerLimit":"12.00","upperLimit":"320.00"}]}]}]},{"title":"Diastolic Blood Pressure","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mm Hg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"78.89","spread":"9.72"},{"groupId":"BG001","value":"78.73","spread":"9.98"},{"groupId":"BG002","value":"79.35","spread":"9.71"},{"groupId":"BG003","value":"78.99","spread":"9.79"}]}]}]},{"title":"Systolic Blood Pressure","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mm Hg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"134.87","spread":"15.00"},{"groupId":"BG001","value":"134.40","spread":"16.32"},{"groupId":"BG002","value":"134.99","spread":"16.68"},{"groupId":"BG003","value":"134.76","spread":"15.98"}]}]}]},{"title":"Diabetes Treatment Satisfaction Questionnaire","description":"The DTSQs questionnaire was used to assess subjects' treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"133"},{"groupId":"BG003","value":"396"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"28.86","spread":"6.35"},{"groupId":"BG001","value":"28.62","spread":"6.45"},{"groupId":"BG002","value":"27.54","spread":"6.55"},{"groupId":"BG003","value":"28.34","spread":"6.46"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c (Glycosylated Haemoglobin)","description":"Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.","populationDescription":"Full analysis set included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of glycosylated hemoglobin","timeFrame":"Week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.45","spread":"0.09"},{"groupId":"OG001","value":"-1.85","spread":"0.09"},{"groupId":"OG002","value":"-0.09","spread":"0.09"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \\[≤8.0% or \\>8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.01","ciUpperLimit":"-1.50","estimateComment":"Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%."},{"groupIds":["OG000","OG002"],"groupDescription":"Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \\[≤8.0% or \\>8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.61","ciUpperLimit":"-1.10","estimateComment":"Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%."}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Estimated mean change from baseline in body weight at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.","populationDescription":"Full analysis set.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.67","spread":"0.36"},{"groupId":"OG001","value":"-6.42","spread":"0.36"},{"groupId":"OG002","value":"-1.36","spread":"0.37"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"Estimated mean change from baseline in FPG at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.","populationDescription":"Full analysis set.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-29.14","spread":"3.74"},{"groupId":"OG001","value":"-42.38","spread":"3.76"},{"groupId":"OG002","value":"-8.51","spread":"4.02"}]}]}]},{"type":"SECONDARY","title":"Change in Insulin Dose","description":"Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. Responses at week 30 are analysed using an Analysis of covariance model with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"0.01"},{"groupId":"OG001","value":"0.85","spread":"0.01"},{"groupId":"OG002","value":"0.96","spread":"0.01"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic and Diastolic Blood Pressure","description":"Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm Hg","timeFrame":"week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"133"}]}],"classes":[{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1.84","spread":"0.73"},{"groupId":"OG001","value":"-1.50","spread":"0.74"},{"groupId":"OG002","value":"-2.17","spread":"0.79"}]}]},{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-4.29","spread":"1.26"},{"groupId":"OG001","value":"-7.27","spread":"1.27"},{"groupId":"OG002","value":"-0.99","spread":"1.34"}]}]}]},{"type":"SECONDARY","title":"Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)","description":"The DTSQs questionnaire was used to assess subjects' treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] and use of metformin \\[yes or no\\]) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"week 0, week 30","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.73","spread":"0.46"},{"groupId":"OG001","value":"3.47","spread":"0.46"},{"groupId":"OG002","value":"1.25","spread":"0.50"}]}]}]},{"type":"SECONDARY","title":"HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target","description":"Percentage of subjects with HbA1C below 7.0% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) 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":"After 30 weeks treatment","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60.6"},{"groupId":"OG001","value":"78.6"},{"groupId":"OG002","value":"10.5"}]}]}]},{"type":"SECONDARY","title":"HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target","description":"Percentage of participants with HbA1c below or equal to 6.5% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \\[\\<= 8.0% or \\> 8.0%\\] crossed with use of metformin \\[yes or no\\]; 2 by 2 levels) 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":"After 30 weeks treatment","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."},{"id":"OG002","title":"Placebo","description":"Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"40.9"},{"groupId":"OG001","value":"61.1"},{"groupId":"OG002","value":"4.5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks).","description":"A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.","eventGroups":[{"id":"EG000","title":"Semaglutide 0.5 mg","description":"Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. 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Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.","seriousNumAffected":9,"seriousNumAtRisk":133,"otherNumAffected":34,"otherNumAtRisk":133}],"seriousEvents":[{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":133}]},{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":133}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue 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