{"protocolSection":{"identificationModule":{"nctId":"NCT02207374","orgStudyIdInfo":{"id":"NN9535-4091"},"secondaryIdInfos":[{"id":"U1111-1140-3081","type":"OTHER","domain":"WHO"},{"id":"JapicCTI-142640","type":"REGISTRY","domain":"JAPIC"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes","officialTitle":"Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy","acronym":"SUSTAIN™"},"statusModule":{"statusVerifiedDate":"2018-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-08-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-02-27","type":"ACTUAL"},"completionDateStruct":{"date":"2016-02-27","type":"ACTUAL"},"studyFirstSubmitDate":"2014-08-01","studyFirstSubmitQcDate":"2014-08-01","studyFirstPostDateStruct":{"date":"2014-08-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-12-21","resultsFirstSubmitQcDate":"2018-06-21","resultsFirstPostDateStruct":{"date":"2019-01-07","type":"ACTUAL"},"dispFirstSubmitDate":"2016-12-06","dispFirstSubmitQcDate":"2017-03-30","dispFirstPostDateStruct":{"date":"2017-03-31","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-06-21","lastUpdatePostDateStruct":{"date":"2019-01-07","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. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy.\n\nAll subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":601,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 0.5 mg","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Semaglutide 1.0 mg","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"One additional OAD + pre-trial treatment","type":"ACTIVE_COMPARATOR","description":"The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen.","interventionNames":["Drug: DPP-4 inhibitor"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.","armGroupLabels":["Semaglutide 0.5 mg","Semaglutide 1.0 mg"]},{"type":"DRUG","name":"DPP-4 inhibitor","description":"Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.","armGroupLabels":["One additional OAD + pre-trial treatment"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AEs) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).","timeFrame":"Weeks 0-56"}],"secondaryOutcomes":[{"measure":"Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \\<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia: was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).","timeFrame":"Weeks 0-56"},{"measure":"Change in Glycosylated Haemoglobin A1c (HbA1c)","description":"The observed mean change in HbA1c values from baseline after 56 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the \"on-treatment without rescue medication\" observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.","timeFrame":"Week 0, week 56"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age at least 20 years at the time of signing informed consent\n* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)\n* Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (week -2)\n\nExclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence \\[not having sex\\], diaphragm, condom \\[by the partner\\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period\n* Treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness\n* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol\n* History of chronic or idiopathic acute pancreatitis\n* Screening calcitonin value above or equal to 50 ng/L (pg/mL)\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\\^2 per modification of diet in renal disease (MDRD) formula (4 variable version)\n* Acute coronary or cerebrovascular event within 90 days before randomisation (Visit 2 \\[week 0\\])\n* Heart failure, New York Heart Association (NYHA) class IV","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Akita-shi, Akita","zip":"010 8543","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Annaka-shi, Gunma","zip":"379 0116","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Asahikawa-shi, Hokkaido","zip":"070 0002","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Asahikawa-shi, Hokkaido","zip":"078 8510","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Bunkyo-ku, Tokyo","zip":"113 8431","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chuo-ku Tokyo","zip":"103-0027","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chuo-ku Tokyo","zip":"104-0031","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chuo-ku, Tokyo","zip":"103 0002","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chuo-ku, Tokyo","zip":"103 0027","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chuo-ku, Tokyo","zip":"104-0061","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Fukuoka","zip":"812 0025","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Novo Nordisk Investigational Site","city":"Higashiosaka-shi, Osaka","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Izumisano","zip":"598 0048","country":"Japan","geoPoint":{"lat":34.41667,"lon":135.31667}},{"facility":"Novo Nordisk Investigational Site","city":"Kashiwara-shi, Osaka","zip":"582 0005","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Katsushika-ku, Tokyo","zip":"125 0054","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kitakyushu-shi, Fukuoka","zip":"800 0252","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Novo Nordisk Investigational Site","city":"Koriyama-shi, Fukushima","zip":"963 8851","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"facility":"Novo Nordisk Investigational Site","city":"Kumamoto-shi,Kumamoto","zip":"862 0976","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kyoto-shi, Kyoto","zip":"615 8125","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Mito-shi, Ibaraki","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Miyazaki","zip":"880 0034","country":"Japan","geoPoint":{"lat":31.91667,"lon":131.41667}},{"facility":"Novo Nordisk Investigational Site","city":"Naka-shi, Ibaraki","zip":"311 0113","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Nishinomiya-shi, Hygo","zip":"662 0971","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Nishinomiya-shi, Hyogo","zip":"663-8501","country":"Japan","geoPoint":{"lat":43.36667,"lon":144.43333}},{"facility":"Novo Nordisk Investigational Site","city":"Okawa-shi, Fukuoka","zip":"831 0016","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Novo Nordisk Investigational Site","city":"Okayama-shi, Okayama","zip":"700 8505","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Osaka-shi, Osaka","zip":"532 0003","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Ota-ku, Tokyo","zip":"144 0035","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Ota-ku, Tokyo","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Oyama-shi, Tochigi","zip":"323 0022","country":"Japan","geoPoint":{"lat":36.38333,"lon":139.73333}},{"facility":"Novo Nordisk Investigational Site","city":"Saga-shi,Saga","zip":"849 0937","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Sapporo-shi, Hokkaido","zip":"060 0062","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Novo Nordisk Investigational Site","city":"Sapporo-shi, Hokkaido","zip":"062 0007","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Novo Nordisk Investigational Site","city":"Sendai","zip":"980 0021","country":"Japan","geoPoint":{"lat":38.26667,"lon":140.86667}},{"facility":"Novo Nordisk Investigational Site","city":"Shimotsuke-shi, Tochigi","zip":"329 0433","country":"Japan","geoPoint":{"lat":36.38333,"lon":139.73333}},{"facility":"Novo Nordisk Investigational Site","city":"Shinjuku-ku, Tokyo","zip":"160-0008","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Shizuoka","zip":"424 0853","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}},{"facility":"Novo Nordisk Investigational Site","city":"Suita-shi, Osaka","zip":"565-0853","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Takatsuki-shi, Osaka","zip":"569 1096","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"103-0028","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"123-0845","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Ube-shi, Yamaguchi","country":"Japan","geoPoint":{"lat":34.18333,"lon":131.46667}},{"facility":"Novo Nordisk Investigational Site","city":"Yokohama","zip":"235 0045","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}}]},"referencesModule":{"references":[{"pmid":"29322610","type":"RESULT","citation":"Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Diabetes Obes Metab. 2018 May;20(5):1202-1212. doi: 10.1111/dom.13218. Epub 2018 Feb 21."},{"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":"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":"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."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects were either on diet and exercise therapy only or on stable treatment on oral anti-diabetic drugs (OADs) mono-therapy \\[either of sulphonyl urea (SU), glinide, alpha-glucosidase inhibitor (α-GI) or thiazolidinediones (TZD)\\] within approved Japanese labelling in addition to diet and exercise therapy before week -2.","recruitmentDetails":"The trial was conducted at 41 sites in Japan.","groups":[{"id":"FG000","title":"Semaglutide 0.5 mg","description":"Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"FG001","title":"Semaglutide 1.0 mg","description":"Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"FG002","title":"Additional OAD","description":"Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"239"},{"groupId":"FG001","numSubjects":"241"},{"groupId":"FG002","numSubjects":"121"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"239"},{"groupId":"FG001","numSubjects":"241"},{"groupId":"FG002","numSubjects":"120"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"233"},{"groupId":"FG001","numSubjects":"231"},{"groupId":"FG002","numSubjects":"115"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Missing follow-up information","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set (FAS) included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD.","groups":[{"id":"BG000","title":"Semaglutide 0.5 mg","description":"Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"BG001","title":"Semaglutide 1.0 mg","description":"Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"BG002","title":"Additional OAD","description":"Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"241"},{"groupId":"BG002","value":"120"},{"groupId":"BG003","value":"600"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.0","spread":"10.6"},{"groupId":"BG001","value":"58.7","spread":"10.2"},{"groupId":"BG002","value":"59.2","spread":"10.1"},{"groupId":"BG003","value":"58.5","spread":"10.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"31"},{"groupId":"BG003","value":"171"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"166"},{"groupId":"BG001","value":"174"},{"groupId":"BG002","value":"89"},{"groupId":"BG003","value":"429"}]}]}]},{"title":"Glycosylated haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated haemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.04","spread":"0.89"},{"groupId":"BG001","value":"8.14","spread":"0.96"},{"groupId":"BG002","value":"8.10","spread":"0.89"},{"groupId":"BG003","value":"8.09","spread":"0.92"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AEs) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).","populationDescription":"The safety analysis set (SAS) included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Number of events","timeFrame":"Weeks 0-56","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"OG002","title":"Additional OAD","description":"Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"241"},{"groupId":"OG002","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"909"},{"groupId":"OG001","value":"954"},{"groupId":"OG002","value":"269"}]}]}]},{"type":"SECONDARY","title":"Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \\<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia: was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).","populationDescription":"The safety analysis set (SAS) included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Number of episodes","timeFrame":"Weeks 0-56","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"OG002","title":"Additional OAD","description":"Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"241"},{"groupId":"OG002","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"2"}]}]}]},{"type":"SECONDARY","title":"Change in Glycosylated Haemoglobin A1c (HbA1c)","description":"The observed mean change in HbA1c values from baseline after 56 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the \"on-treatment without rescue medication\" observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.","populationDescription":"The full analysis set (FAS) included all randomised subjects who have received at least one dose of trial product. All subjects contributed to the statistical model of the data analysis, but not all subjects had a value at week 56.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage (%) of HbA1c","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Semaglutide 0.5 mg","description":"Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial."},{"id":"OG002","title":"Additional OAD","description":"Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.74","spread":"0.05"},{"groupId":"OG001","value":"-2.03","spread":"0.05"},{"groupId":"OG002","value":"-0.67","spread":"0.07"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"All AEs mentioned here are treatment emergent adverse events (TEAE), defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).","description":"The safety analysis set included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS contributed to the evaluation \"as treated\".","eventGroups":[{"id":"EG000","title":"Semaglutide 0.5 mg","description":"Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.","seriousNumAffected":19,"seriousNumAtRisk":239,"otherNumAffected":160,"otherNumAtRisk":239},{"id":"EG001","title":"Semaglutide 1.0 mg","description":"Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.","seriousNumAffected":12,"seriousNumAtRisk":241,"otherNumAffected":169,"otherNumAtRisk":241},{"id":"EG002","title":"Additional OAD","description":"Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial.","seriousNumAffected":8,"seriousNumAtRisk":120,"otherNumAffected":61,"otherNumAtRisk":120}],"seriousEvents":[{"term":"Adenocarcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 18","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":241},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Anal fistula","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":241},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Atrial fibrillation","organSystem":"Cardiac 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