{"protocolSection":{"identificationModule":{"nctId":"NCT01930188","orgStudyIdInfo":{"id":"NN9535-3626"},"secondaryIdInfos":[{"id":"2012-004827-19","type":"EUDRACT_NUMBER"},{"id":"U1111-1135-8730","type":"OTHER","domain":"WHO"},{"id":"132366","type":"OTHER","domain":"JapicCTI"},{"id":"CTRI/2014/05/004626","type":"REGISTRY","domain":"Clinical Trial Registry India (CTRI)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2 - vs. DPP-4 Inhibitor)","acronym":"SUSTAIN™ 2"},"statusModule":{"statusVerifiedDate":"2019-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-12-02","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-10-12","type":"ACTUAL"},"completionDateStruct":{"date":"2015-10-12","type":"ACTUAL"},"studyFirstSubmitDate":"2013-08-23","studyFirstSubmitQcDate":"2013-08-23","studyFirstPostDateStruct":{"date":"2013-08-28","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-12-14","resultsFirstSubmitQcDate":"2018-06-21","resultsFirstPostDateStruct":{"date":"2019-01-07","type":"ACTUAL"},"dispFirstSubmitDate":"2016-11-10","dispFirstSubmitQcDate":"2016-11-10","dispFirstPostDateStruct":{"date":"2016-11-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-05-28","lastUpdatePostDateStruct":{"date":"2019-06-13","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) 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":1231,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 0.5 mg + sitagliptin placebo","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide","Drug: placebo"]},{"label":"Semaglutide 1.0 mg + sitagliptin placebo","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide","Drug: placebo"]},{"label":"Sitagliptin 100 mg + semaglutide placebo 1.0 mg","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: sitagliptin","Drug: placebo"]},{"label":"Sitagliptin 100 mg + semaglutide placebo 0.5 mg","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: sitagliptin","Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.","armGroupLabels":["Semaglutide 0.5 mg + sitagliptin placebo","Semaglutide 1.0 mg + sitagliptin placebo"]},{"type":"DRUG","name":"sitagliptin","description":"Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.","armGroupLabels":["Sitagliptin 100 mg + semaglutide placebo 0.5 mg","Sitagliptin 100 mg + semaglutide placebo 1.0 mg"]},{"type":"DRUG","name":"placebo","description":"Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.","armGroupLabels":["Semaglutide 0.5 mg + sitagliptin placebo","Semaglutide 1.0 mg + sitagliptin placebo"]},{"type":"DRUG","name":"placebo","description":"For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.","armGroupLabels":["Sitagliptin 100 mg + semaglutide placebo 0.5 mg","Sitagliptin 100 mg + semaglutide placebo 1.0 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c (Glycosylated Haemoglobin) From Baseline","description":"Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.","timeFrame":"Week 0, week 56"}],"secondaryOutcomes":[{"measure":"Change in Body Weight From Baseline","description":"Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.","timeFrame":"Week 0, week 56"},{"measure":"Change in Fasting Plasma Glucose (FPG) From Baseline","description":"Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.","timeFrame":"Week 0, week 56"},{"measure":"Change in Systolic and Diastolic Blood Pressure From Baseline","description":"Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin","timeFrame":"Week 0, week 56"},{"measure":"Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline","description":"Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. This questionnaire 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.","timeFrame":"Week 0, week 56"},{"measure":"Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)","description":"Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.","timeFrame":"After 56 weeks treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - 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 glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - 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 type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m2 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, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational 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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."},{"type":"RESULT","citation":"Ahrén B, Comas LM, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). Oral Presentation 12 Jun 2016 at American Diabetes Association - 76th Annual Scientific Sessions."},{"type":"RESULT","citation":"Ahrén B, Masmiquel L, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). ePoster #767 presented 12 Sep 2016 at European Association for the Study of Diabetes - 52nd Annual Meeting."},{"pmid":"28385659","type":"RESULT","citation":"Ahren B, Masmiquel L, Kumar H, Sargin M, Karsbol JD, Jacobsen SH, Chow F. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol. 2017 May;5(5):341-354. doi: 10.1016/S2213-8587(17)30092-X. Epub 2017 Apr 3."},{"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":"29764222","type":"RESULT","citation":"Sharma R, Wilkinson L, Vrazic H, Popoff E, Lopes S, Kanters S, Druyts E. Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. Curr Med Res Opin. 2018 Sep;34(9):1595-1603. doi: 10.1080/03007995.2018.1476332. Epub 2018 May 29."},{"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":"37178435","type":"DERIVED","citation":"Pulleyblank R, Larsen NB. Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study. Pharmacoecon Open. 2023 Jul;7(4):579-591. doi: 10.1007/s41669-023-00416-z. Epub 2023 May 13."},{"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":"32827435","type":"DERIVED","citation":"Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577."},{"pmid":"32193837","type":"DERIVED","citation":"Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19."},{"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 124 sites in 18 countries: Argentina: 4; Bulgaria: 10; Czech Republic: 5; Hong Kong: 1; Hungary: 4; India: 11; Japan: 14; Mexico: 5 Norway: 5; Portugal: 6; Romania: 5; Russian Federation: 17; South Africa: 7; Spain: 7: Sweden: 4; Thailand: 4; Turkey: 9; and Ukraine: 6 sites.","groups":[{"id":"FG000","title":"Semaglutide 0.5 mg + Sitagliptin Placebo","description":"Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"FG001","title":"Semaglutide 1.0 mg + Sitagliptin Placebo","description":"Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"FG002","title":"Sitagliptin + Semaglutide Placebo","description":"Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"409"},{"groupId":"FG001","numSubjects":"409"},{"groupId":"FG002","numSubjects":"407"}]},{"type":"Premature Discontinuation of Treatment","achievements":[{"groupId":"FG000","comment":"Subjects prematurely discontinued treatment were allowed to continue participation in the trial.","numSubjects":"53"},{"groupId":"FG001","comment":"Subjects prematurely discontinued treatment were allowed to continue participation in the trial.","numSubjects":"61"},{"groupId":"FG002","comment":"Subjects prematurely discontinued treatment were allowed to continue participation in the trial.","numSubjects":"32"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"387"},{"groupId":"FG001","numSubjects":"388"},{"groupId":"FG002","numSubjects":"388"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"19"}]}],"dropWithdraws":[{"type":"unclassified","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Missing follow-up information","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"8"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Of 1231 randomised subjects, 6 were excluded: 1 subject each in the semaglutide 0.5 mg and 1.0 mg arms and 4 subjects in the sitagliptin arm were not exposed to trial treatment. Baseline characteristics were presented for 1225 subjects (Full Analysis Set), who received at least one dose of randomised semaglutide or sitagliptin.","groups":[{"id":"BG000","title":"Semaglutide 0.5 mg + Sitagliptin Placebo","description":"Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"BG001","title":"Semaglutide 1.0 mg + Sitagliptin Placebo","description":"Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"BG002","title":"Sitagliptin + Semaglutide Placebo","description":"Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"409"},{"groupId":"BG001","value":"409"},{"groupId":"BG002","value":"407"},{"groupId":"BG003","value":"1225"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.8","spread":"10.2"},{"groupId":"BG001","value":"56.0","spread":"9.4"},{"groupId":"BG002","value":"54.6","spread":"10.4"},{"groupId":"BG003","value":"55.1","spread":"10.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"202"},{"groupId":"BG001","value":"204"},{"groupId":"BG002","value":"199"},{"groupId":"BG003","value":"605"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"207"},{"groupId":"BG001","value":"205"},{"groupId":"BG002","value":"208"},{"groupId":"BG003","value":"620"}]}]}]},{"title":"HbA1c","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.01","spread":"0.92"},{"groupId":"BG001","value":"8.04","spread":"0.93"},{"groupId":"BG002","value":"8.17","spread":"0.92"},{"groupId":"BG003","value":"8.07","spread":"0.93"}]}]}]},{"title":"Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilograms","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"89.93","spread":"20.39"},{"groupId":"BG001","value":"89.21","spread":"20.74"},{"groupId":"BG002","value":"89.29","spread":"19.67"},{"groupId":"BG003","value":"89.48","spread":"20.26"}]}]}]},{"title":"Fasting Plasma Glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9.33","spread":"2.38"},{"groupId":"BG001","value":"9.29","spread":"2.22"},{"groupId":"BG002","value":"9.60","spread":"2.16"},{"groupId":"BG003","value":"9.40","spread":"2.26"}]}]}]},{"title":"Diastolic and Systolic Blood Pressure","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"title":"Diastolic Blood pressure","categories":[{"measurements":[{"groupId":"BG000","value":"80.63","spread":"9.76"},{"groupId":"BG001","value":"80.87","spread":"9.08"},{"groupId":"BG002","value":"80.48","spread":"8.70"},{"groupId":"BG003","value":"80.66","spread":"9.19"}]}]},{"title":"Systolic Blood pressure","categories":[{"measurements":[{"groupId":"BG000","value":"132.73","spread":"16.09"},{"groupId":"BG001","value":"132.56","spread":"13.93"},{"groupId":"BG002","value":"132.66","spread":"14.58"},{"groupId":"BG003","value":"132.65","spread":"14.88"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c (Glycosylated Haemoglobin) From Baseline","description":"Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.","populationDescription":"Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of glycosylated haemoglobin","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg + Sitagliptin Placebo","description":"Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG001","title":"Semaglutide 1.0 mg + Sitagliptin Placebo","description":"Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG002","title":"Sitagliptin + Semaglutide Placebo","description":"Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"409"},{"groupId":"OG001","value":"409"},{"groupId":"OG002","value":"407"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.32","spread":"0.05"},{"groupId":"OG001","value":"-1.61","spread":"0.05"},{"groupId":"OG002","value":"-0.55","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Post-baseline responses analysed with mixed model for repeated measurements-treatment \\& country (fixed) \\& baseline (covariate) all nested within visit","paramType":"treatment difference","paramValue":"-1.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.21","ciUpperLimit":"-0.91"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 0.5 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analysis done with mixed model for repeated measurements (treatment \\& country as fixed factors \\& baseline value as covariate) all nested within visit","paramType":"treatment difference","paramValue":"-0.92","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.21","ciUpperLimit":"-0.62"}]},{"type":"SECONDARY","title":"Change in Body Weight From Baseline","description":"Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.","populationDescription":"Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg + Sitagliptin Placebo","description":"Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG001","title":"Semaglutide 1.0 mg + Sitagliptin Placebo","description":"Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG002","title":"Sitagliptin + Semaglutide Placebo","description":"Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"409"},{"groupId":"OG001","value":"409"},{"groupId":"OG002","value":"407"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.28","spread":"0.25"},{"groupId":"OG001","value":"-6.13","spread":"0.25"},{"groupId":"OG002","value":"-1.93","spread":"0.26"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG) From Baseline","description":"Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.","populationDescription":"Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg + Sitagliptin Placebo","description":"Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG001","title":"Semaglutide 1.0 mg + Sitagliptin Placebo","description":"Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG002","title":"Sitagliptin + Semaglutide Placebo","description":"Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. 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Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG001","title":"Semaglutide 1.0 mg + Sitagliptin Placebo","description":"Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG002","title":"Sitagliptin + Semaglutide Placebo","description":"Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"409"},{"groupId":"OG001","value":"409"},{"groupId":"OG002","value":"407"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-5.07","spread":"0.64"},{"groupId":"OG001","value":"-5.61","spread":"0.63"},{"groupId":"OG002","value":"-2.29","spread":"0.67"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-2.01","spread":"0.42"},{"groupId":"OG001","value":"-1.91","spread":"0.42"},{"groupId":"OG002","value":"-1.11","spread":"0.44"}]}]}]},{"type":"SECONDARY","title":"Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline","description":"Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. 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Sitagliptin placebo (0 mg) administered orally once daily."},{"id":"OG002","title":"Sitagliptin + Semaglutide Placebo","description":"Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"333"},{"groupId":"OG001","value":"333"},{"groupId":"OG002","value":"294"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.28","spread":"0.23"},{"groupId":"OG001","value":"5.91","spread":"0.23"},{"groupId":"OG002","value":"4.45","spread":"0.24"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)","description":"Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.","populationDescription":"Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Subjects","timeFrame":"After 56 weeks treatment","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg + Sitagliptin Placebo","description":"Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. 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