{"protocolSection":{"identificationModule":{"nctId":"NCT03989232","orgStudyIdInfo":{"id":"NN9535-4506"},"secondaryIdInfos":[{"id":"U1111-1224-5162","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2018-004529-96","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"2018","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2018"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes","acronym":"SUSTAIN FORTE"},"statusModule":{"statusVerifiedDate":"2023-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-06-19","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-09-18","type":"ACTUAL"},"completionDateStruct":{"date":"2020-11-09","type":"ACTUAL"},"studyFirstSubmitDate":"2019-06-14","studyFirstSubmitQcDate":"2019-06-14","studyFirstPostDateStruct":{"date":"2019-06-18","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-08-04","resultsFirstSubmitQcDate":"2021-09-24","resultsFirstPostDateStruct":{"date":"2021-10-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-02-10","lastUpdatePostDateStruct":{"date":"2023-02-13","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":961,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 2.0 mg","type":"EXPERIMENTAL","description":"All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.","interventionNames":["Drug: Semaglutide"]},{"label":"Semaglutide 1.0 mg","type":"ACTIVE_COMPARATOR","description":"All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.","interventionNames":["Drug: Semaglutide","Drug: Placebo (semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.","armGroupLabels":["Semaglutide 1.0 mg","Semaglutide 2.0 mg"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"Semaglutide placebo injected once-weekly from week 13 to week 40.","armGroupLabels":["Semaglutide 1.0 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c","description":"Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated.\n\nResults are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.","timeFrame":"Week 0, week 40"}],"secondaryOutcomes":[{"measure":"Change in Body Weight","description":"Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.","timeFrame":"Week 0, week 40"},{"measure":"Change in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.","timeFrame":"Week 0, week 40"},{"measure":"Change in Body Mass Index (BMI)","description":"Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.","timeFrame":"Week 0, week 40"},{"measure":"Change in Waist Circumference","description":"Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.","timeFrame":"Week 0, week 40"},{"measure":"Participants Who Achieved HbA1c < 7.0%","description":"Percentage of participants who achieved HbA1c \\< 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.","timeFrame":"Week 40"},{"measure":"Participants Who Achieved HbA1c ≤ 6.5%","description":"Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.","timeFrame":"Week 40"},{"measure":"Participants Who Achieved Weight Loss ≥5%","description":"Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.","timeFrame":"Week 40"},{"measure":"Participants Who Achieved Weight Loss ≥10%","description":"Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.","timeFrame":"Week 40"},{"measure":"Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value \\<3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.","timeFrame":"Week 0 to week 47"},{"measure":"Change in Pulse Rate","description":"Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.","timeFrame":"Week 0, week 40"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age equal to or above18 years at the time of signing informed consent\n* Diagnosed with T2D at least 180 days prior to the day of screening\n* HbA1c of 8-10% (64-86 mmol/mol) (both inclusive)\n* Stable daily dose(s) for 90 days prior to the day of screening of:\n* Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)\n\nExclusion Criteria:\n\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes\n* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of \\<30 mL/min/1.73 m\\^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Reporting Anchor and Disclosure (1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35205","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Chandler","state":"Arizona","zip":"85224","country":"United States","geoPoint":{"lat":33.30616,"lon":-111.84125}},{"facility":"Novo Nordisk Investigational Site","city":"Glendale","state":"Arizona","zip":"85306","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"Novo Nordisk Investigational 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Efficacy and safety of once-weekly semaglutide 2.0 mg versus 1.0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):563-574. doi: 10.1016/S2213-8587(21)00174-1. Epub 2021 Jul 21."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants with type 2 diabetes (T2D) treated with stable doses of metformin only, or metformin in combination with sulfonylurea (SU), in need of the treatment intensification were randomized 1:1 to once-weekly treatment with semaglutide 2.0 milligrams (mg) or once-weekly treatment with semaglutide 1.0 mg.","recruitmentDetails":"The trial was conducted at 125 sites in Bulgaria (9), Canada (8), Czech Republic (4), Greece (6), Hungary (12), Japan (2), Poland (10), Slovakia (11), Ukraine (5) and the United States (58). In addition to these sites, 4 sites in the US screened but did not randomize participants, and 3 sites were approved by the IRB/IEC but did not screen or assign any participants to treatment.","groups":[{"id":"FG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"FG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"481"},{"groupId":"FG001","numSubjects":"480"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"480"},{"groupId":"FG001","numSubjects":"479"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"480"},{"groupId":"FG001","numSubjects":"479"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"481"},{"groupId":"FG001","numSubjects":"480"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"471"},{"groupId":"FG001","numSubjects":"462"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"18"}]}],"dropWithdraws":[{"type":"Lost to 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end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.","populationDescription":"The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 0, week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"480"}]}],"classes":[{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"422"},{"groupId":"OG001","value":"423"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"1.0"},{"groupId":"OG001","value":"-2.2","spread":"1.0"}]}]},{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"456"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.9","spread":"1.0"},{"groupId":"OG001","value":"-2.2","spread":"1.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"On-treatment without rescue medication observation period: Imputation of missing data was handled by multiple imputation (MI) assuming that missing data were missed at random (MAR). The imputation was performed separately within each treatment group defined by randomised treatment.","nonInferiorityType":"SUPERIORITY","pValue":"0.0003","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"-0.11"},{"groupIds":["OG000","OG001"],"groupDescription":"In-trial observation period: Imputation of missing data was handled by MI assuming that missing data were missed at random. The imputation was performed by imputing missing week 40 data separately within groups defined by randomised treatment and treatment status at week 40.","nonInferiorityType":"SUPERIORITY","pValue":"0.0098","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.31","ciUpperLimit":"-0.04"}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.","populationDescription":"The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (kg)","timeFrame":"Week 0, week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"480"}]}],"classes":[{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"434"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.0","spread":"5.8"},{"groupId":"OG001","value":"-7.0","spread":"5.8"}]}]},{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"467"},{"groupId":"OG001","value":"457"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-5.7","spread":"5.9"},{"groupId":"OG001","value":"-6.7","spread":"5.9"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.","populationDescription":"The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per liter (mmol/L)","timeFrame":"Week 0, week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"423"},{"groupId":"OG001","value":"429"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.2","spread":"2.8"},{"groupId":"OG001","value":"-3.4","spread":"3.1"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index (BMI)","description":"Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.","populationDescription":"The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram per squaremeter (Kg/m^2)","timeFrame":"Week 0, week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"434"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"2.1"},{"groupId":"OG001","value":"-2.5","spread":"2.1"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.","populationDescription":"The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter (cm)","timeFrame":"Week 0, week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"423"},{"groupId":"OG001","value":"433"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.2","spread":"6.1"},{"groupId":"OG001","value":"-5.9","spread":"6.2"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c < 7.0%","description":"Percentage of participants who achieved HbA1c \\< 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.","populationDescription":"The FAS included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"480"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57.5"},{"groupId":"OG001","value":"67.6"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c ≤ 6.5%","description":"Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.","populationDescription":"The FAS included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"480"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.5"},{"groupId":"OG001","value":"51.7"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved Weight Loss ≥5%","description":"Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.","populationDescription":"The FAS included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"480"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.3"},{"groupId":"OG001","value":"59.2"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved Weight Loss ≥10%","description":"Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.","populationDescription":"The FAS included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"480"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.6"},{"groupId":"OG001","value":"28.4"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value \\<3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.","populationDescription":"The SAS included all participants exposed to at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Week 0 to week 47","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"480"},{"groupId":"OG001","value":"479"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"21"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate","description":"Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.","populationDescription":"The SAS included all participants exposed to at least one dose of trial product. Overall number of participants analyzed=number of participants contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute","timeFrame":"Week 0, week 40","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks."},{"id":"OG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"444"},{"groupId":"OG001","value":"442"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.8","spread":"10.0"},{"groupId":"OG001","value":"3.3","spread":"9.5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Weeks 0-47","description":"All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.","eventGroups":[{"id":"EG000","title":"Semaglutide 1.0 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.","deathsNumAffected":1,"deathsNumAtRisk":480,"seriousNumAffected":25,"seriousNumAtRisk":480,"otherNumAffected":126,"otherNumAtRisk":480},{"id":"EG001","title":"Semaglutide 2.0 mg","description":"Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.","deathsNumAffected":2,"deathsNumAtRisk":479,"seriousNumAffected":21,"seriousNumAtRisk":479,"otherNumAffected":132,"otherNumAtRisk":479}],"seriousEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":480},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":479}]},{"term":"Acute kidney injury","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":480},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":479}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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