{"protocolSection":{"identificationModule":{"nctId":"NCT03689374","orgStudyIdInfo":{"id":"NN9535-4386"},"secondaryIdInfos":[{"id":"U1111-1200-0164","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2017-003219-20","type":"REGISTRY","domain":"EudraCT"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes","officialTitle":"Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes","acronym":"SUSTAIN 11"},"statusModule":{"statusVerifiedDate":"2022-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-10-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-02-22","type":"ACTUAL"},"completionDateStruct":{"date":"2021-02-22","type":"ACTUAL"},"studyFirstSubmitDate":"2018-09-27","studyFirstSubmitQcDate":"2018-09-27","studyFirstPostDateStruct":{"date":"2018-09-28","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-02-21","resultsFirstSubmitQcDate":"2022-04-28","resultsFirstPostDateStruct":{"date":"2022-05-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-11-10","lastUpdatePostDateStruct":{"date":"2022-11-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":2274,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Run-in period (12 weeks): subjects will be treated with metformin and insulin glargine (IGlar) U100.\n\nTreatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in will receive semaglutide for 52 weeks in addition to metformin and IGlar U100.\n\nMetformin will be considered as background therapy during the trial.","interventionNames":["Drug: Semaglutide","Drug: Insulin glargine U100"]},{"label":"Insulin aspart","type":"ACTIVE_COMPARATOR","description":"Run-in period (12 weeks): subjects will be treated with metformin and insulin IGlar U100.\n\nTreatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in receive insulin aspart for 52 weeks in addition to metformin and IGlar U100.\n\nMetformin will be considered as background therapy during the trial.","interventionNames":["Drug: Insulin aspart","Drug: Insulin glargine U100"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"Insulin aspart","description":"Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days","armGroupLabels":["Insulin aspart"]},{"type":"DRUG","name":"Insulin glargine U100","description":"Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)","armGroupLabels":["Insulin aspart","Semaglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycated Haemoglobin (HbA1c)","description":"Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"}],"secondaryOutcomes":[{"measure":"Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52","description":"First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (\\<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"From randomization (week 0) up to week 52"},{"measure":"Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52","description":"First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"From randomization (week 0) up to week 52"},{"measure":"Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52","description":"Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"From randomization (week 0) to week 52"},{"measure":"Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52","description":"Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \\<3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"From randomization (week 0) to week 52"},{"measure":"Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52","description":"Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \\<=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration \\<= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"From randomization (week 0) to week 52"},{"measure":"Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52","description":"Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"From randomization (week 0) to week 52"},{"measure":"Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52","description":"Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose \\< 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose \\< 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"From randomization (week 0) to week 52"},{"measure":"Daily Basal Insulin Dose at Week 52","description":"Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"At week 52"},{"measure":"Total Daily Insulin Dose at Week 52","description":"Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"At week 52"},{"measure":"Change From Baseline to Week 52 in Body Weight (Kilogram (kg))","description":"Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)","description":"Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)","description":"Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)","description":"Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Body Mass Index (BMI)","description":"Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Waist Circumference","description":"Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline","description":"Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)","description":"Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)","description":"Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)","description":"Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)","description":"Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure","description":"Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Pulse Rate","description":"Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains","description":"SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains","description":"The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","timeFrame":"Baseline (week 0), week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age greater than or equal to 18 years at the time of signing informed consent\n* Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening\n* Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening\n* Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors\n* Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)\n\nExclusion Criteria:\n\n* History or presence of pancreatitis (acute or chronic)\n* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening\n* Subjects presently classified as being in New York Heart Association Class IV\n* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\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 bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. 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Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial. Diabetes Obes Metab. 2022 Sep;24(9):1788-1799. doi: 10.1111/dom.14765. Epub 2022 Jun 29."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"This trial consisted of 12-week run-in, 52-week treatment period and participants were followed up 5 weeks for safety. Participants were randomized 1:1 to receive treatment with: metformin + insulin glargine (IGlar) U100 + once-weekly semaglutide subcutaneously (s.c). or metformin + insulin glargine U100 + mealtime insulin aspart s.c. three times daily.","recruitmentDetails":"The trial was conducted at 209 sites in 21 countries: Bosnia-Herzegovina (3 sites), Bulgaria (9 sites), Croatia (7 sites), Czech Republic (7 sites), Estonia (5 sites), Germany (25 sites), Greece (14 sites), Hungary (8 sites), India (20 sites), Latvia (7 sites), Lithuania (6 sites), Macedonia (3 sites), Poland (20 sites), Portugal (6 sites), Romania (7 sites), Serbia (14 sites), Slovakia (9 sites), Slovenia (6 sites), South Africa (11 sites), Spain (8 sites) and Turkey (14 sites).","groups":[{"id":"FG000","title":"All Participants","description":"During run-in period insulin glargine in combination with metformin was to be optimized. All enrolled participants received metformin orally and IGlar U100 s.c. injection in run-in period. Metformin was optimized in dose range of greater than or equal to (\\>=) 1500 milligrams (mg) to less than or equal to (\\<=) 3000 mg. After run-in period, participants were randomized 1:1 to receive add-on treatment with semaglutide once weekly or insulin aspart three times daily (TID) in treatment period."},{"id":"FG001","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"FG002","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"periods":[{"title":"Run-in Period (12 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"2274"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1748"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"526"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Run-in failure","reasons":[{"groupId":"FG000","numSubjects":"526"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Treatment Period (Week 0 to 52)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"874"},{"groupId":"FG002","numSubjects":"874"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"874"},{"groupId":"FG002","numSubjects":"864"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"874"},{"groupId":"FG002","numSubjects":"874"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"874"},{"groupId":"FG002","numSubjects":"864"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"850"},{"groupId":"FG002","numSubjects":"831"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"43"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"38"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set included all randomized participants.","groups":[{"id":"BG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"BG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"874"},{"groupId":"BG001","value":"874"},{"groupId":"BG002","value":"1748"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.8","spread":"9.4"},{"groupId":"BG001","value":"61.5","spread":"9.5"},{"groupId":"BG002","value":"61.2","spread":"9.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"429"},{"groupId":"BG001","value":"425"},{"groupId":"BG002","value":"854"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"445"},{"groupId":"BG001","value":"449"},{"groupId":"BG002","value":"894"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"45"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"851"},{"groupId":"BG001","value":"852"},{"groupId":"BG002","value":"1703"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Race","categories":[{"title":"American Indian or Alaska native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"176"},{"groupId":"BG001","value":"166"},{"groupId":"BG002","value":"342"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"35"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"674"},{"groupId":"BG001","value":"691"},{"groupId":"BG002","value":"1365"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Glycated Haemoglobin (HbA1c)","description":"Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"795"},{"groupId":"OG001","value":"783"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"1.0"},{"groupId":"OG001","value":"-1.2","spread":"1.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"The responses were analyzed using an ANCOVA with treatment as fixed factor and baseline value as a covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomized treatment, using a regression model including randomized treatment group and data from baseline and all previous visits as covariates. The prespecified non inferiority margin was 0.3%-point.","pValue":"<0.0001","statisticalMethod":"t-distributed test","statisticalComment":"The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test.","paramType":"Treatment difference","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.38","ciUpperLimit":"-0.20"}]},{"type":"SECONDARY","title":"Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52","description":"First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (\\<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"First event per 100 years of exposure","timeFrame":"From randomization (week 0) up to week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"874"},{"groupId":"OG001","value":"864"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.4"},{"groupId":"OG001","value":"0.7"}]}]}]},{"type":"SECONDARY","title":"Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52","description":"First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"First event per 100 years of exposure","timeFrame":"From randomization (week 0) up to week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"874"},{"groupId":"OG001","value":"864"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.2"},{"groupId":"OG001","value":"0.4"}]}]}]},{"type":"SECONDARY","title":"Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52","description":"Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From randomization (week 0) to week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"874"},{"groupId":"OG001","value":"874"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"}]}]}]},{"type":"SECONDARY","title":"Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52","description":"Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \\<3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From randomization (week 0) to week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"874"},{"groupId":"OG001","value":"874"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"254"},{"groupId":"OG001","value":"1744"}]}]}]},{"type":"SECONDARY","title":"Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52","description":"Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \\<=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration \\<= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From randomization (week 0) to week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"874"},{"groupId":"OG001","value":"874"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1420"},{"groupId":"OG001","value":"5616"}]}]}]},{"type":"SECONDARY","title":"Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52","description":"Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From randomization (week 0) to week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"874"},{"groupId":"OG001","value":"874"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}]}]},{"type":"SECONDARY","title":"Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52","description":"Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose \\< 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \\<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose \\< 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From randomization (week 0) to week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"874"},{"groupId":"OG001","value":"874"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"2270"}]}]}]},{"type":"SECONDARY","title":"Daily Basal Insulin Dose at Week 52","description":"Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units of insulin","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"803"},{"groupId":"OG001","value":"794"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35.8","spread":"19.4"},{"groupId":"OG001","value":"40.7","spread":"22.0"}]}]}]},{"type":"SECONDARY","title":"Total Daily Insulin Dose at Week 52","description":"Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units of insulin","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"803"},{"groupId":"OG001","value":"797"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35.8","spread":"19.4"},{"groupId":"OG001","value":"77.7","spread":"40.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Body Weight (Kilogram (kg))","description":"Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilograms","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"801"},{"groupId":"OG001","value":"793"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"4.6"},{"groupId":"OG001","value":"2.9","spread":"4.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)","description":"Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"770"},{"groupId":"OG001","value":"762"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"2.9"},{"groupId":"OG001","value":"-0.8","spread":"3.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)","description":"Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"757"},{"groupId":"OG001","value":"737"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"2.0"},{"groupId":"OG001","value":"-2.1","spread":"2.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)","description":"Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure .","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"747"},{"groupId":"OG001","value":"724"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"1.8"},{"groupId":"OG001","value":"-0.9","spread":"2.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Body Mass Index (BMI)","description":"Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilograms per meter square (kg/m^2)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"801"},{"groupId":"OG001","value":"793"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"1.7"},{"groupId":"OG001","value":"1.0","spread":"1.5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Waist Circumference","description":"Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"centimeters (cm)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"799"},{"groupId":"OG001","value":"793"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.3","spread":"5.6"},{"groupId":"OG001","value":"2.1","spread":"4.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline","description":"Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of body weight","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"801"},{"groupId":"OG001","value":"793"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"0.1"},{"groupId":"OG001","value":"1.0","spread":"0.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)","description":"Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"792"},{"groupId":"OG001","value":"784"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"19.6"},{"groupId":"OG001","value":"1.0","spread":"20.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)","description":"Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"789"},{"groupId":"OG001","value":"781"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"36.2"},{"groupId":"OG001","value":"1.0","spread":"35.2"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)","description":"Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"751"},{"groupId":"OG001","value":"741"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"16.7"},{"groupId":"OG001","value":"1.0","spread":"16.4"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)","description":"Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"789"},{"groupId":"OG001","value":"781"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"40.4"},{"groupId":"OG001","value":"1.0","spread":"42.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure","description":"Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeter of mercury (mmHg)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"784"},{"groupId":"OG001","value":"765"}]}],"classes":[{"title":"Diastolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"8.7"},{"groupId":"OG001","value":"-0.4","spread":"9.0"}]}]},{"title":"Systolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-2.8","spread":"13.8"},{"groupId":"OG001","value":"1.0","spread":"14.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Pulse Rate","description":"Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute (beats/min)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"784"},{"groupId":"OG001","value":"765"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"8.7"},{"groupId":"OG001","value":"1.1","spread":"8.7"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains","description":"SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = participants with available data for each specified category.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"803"},{"groupId":"OG001","value":"794"}]}],"classes":[{"title":"Physical Component Summary","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"791"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"6.4"},{"groupId":"OG001","value":"0.4","spread":"6.7"}]}]},{"title":"Mental Component Summary","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"792"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"8.6"},{"groupId":"OG001","value":"-0.3","spread":"8.4"}]}]},{"title":"Physical Functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"803"},{"groupId":"OG001","value":"793"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"7.7"},{"groupId":"OG001","value":"0.2","spread":"7.8"}]}]},{"title":"Role Physical Health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"794"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"7.8"},{"groupId":"OG001","value":"-0.2","spread":"8.0"}]}]},{"title":"Bodily Pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"793"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"9.0"},{"groupId":"OG001","value":"0.8","spread":"9.8"}]}]},{"title":"General Health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"803"},{"groupId":"OG001","value":"794"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"8.0"},{"groupId":"OG001","value":"0.3","spread":"8.0"}]}]},{"title":"Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"792"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"8.6"},{"groupId":"OG001","value":"0.1","spread":"7.9"}]}]},{"title":"Social Functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"793"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"9.5"},{"groupId":"OG001","value":"-0.6","spread":"9.1"}]}]},{"title":"Role Emotional Problem","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"793"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"9.4"},{"groupId":"OG001","value":"-0.2","spread":"9.8"}]}]},{"title":"Mental Health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"792"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"8.7"},{"groupId":"OG001","value":"0.1","spread":"8.7"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains","description":"The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = participants with available data for each specified category.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety."},{"id":"OG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"795"}]}],"classes":[{"title":"Physical function","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"794"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.4","spread":"24.6"},{"groupId":"OG001","value":"-0.4","spread":"26.4"}]}]},{"title":"Energy or fatigue","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"802"},{"groupId":"OG001","value":"794"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.3","spread":"13.0"},{"groupId":"OG001","value":"0.4","spread":"12.9"}]}]},{"title":"Health distress","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"801"},{"groupId":"OG001","value":"794"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"12.4"},{"groupId":"OG001","value":"0.3","spread":"13.2"}]}]},{"title":"Mental health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"800"},{"groupId":"OG001","value":"795"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.2","spread":"18.5"},{"groupId":"OG001","value":"0.5","spread":"20.2"}]}]},{"title":"Satisfaction","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"799"},{"groupId":"OG001","value":"794"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.1","spread":"18.6"},{"groupId":"OG001","value":"-0.2","spread":"16.2"}]}]},{"title":"Treatment satisfaction","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"799"},{"groupId":"OG001","value":"792"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.9","spread":"23.9"},{"groupId":"OG001","value":"0.8","spread":"24.4"}]}]},{"title":"Treatment flexibility","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"798"},{"groupId":"OG001","value":"794"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.2","spread":"20.1"},{"groupId":"OG001","value":"-1.2","spread":"19.8"}]}]},{"title":"Frequency of symptoms","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"798"},{"groupId":"OG001","value":"794"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.1","spread":"15.5"},{"groupId":"OG001","value":"1.8","spread":"14.7"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From week 0 to week 52","description":"All presented adverse events (AEs) are treatment-emergent (i.e., TEAEs). TEAEs were defined as AEs with onset during the 'on-treatment' observation period. Results are based on the safety analysis set (SAS) which included all participants exposed to at least one dose of trial product. One participant died after completing end-of-study visit by an ongoing AE which created discrepancies between all cause mortality deaths and participant flow deaths.","eventGroups":[{"id":"EG000","title":"Semaglutide","description":"Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety.","deathsNumAffected":12,"deathsNumAtRisk":874,"seriousNumAffected":65,"seriousNumAtRisk":874,"otherNumAffected":225,"otherNumAtRisk":874},{"id":"EG001","title":"Insulin Aspart","description":"Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety.","deathsNumAffected":1,"deathsNumAtRisk":864,"seriousNumAffected":84,"seriousNumAtRisk":864,"otherNumAffected":65,"otherNumAtRisk":864}],"seriousEvents":[{"term":"Abdominal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":874},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":864}]},{"term":"Abscess sweat gland","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":874},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":864}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":874},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":864}]},{"term":"Bowen's disease","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":874},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":864}]},{"term":"Bradyarrhythmia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":874},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":864}]},{"term":"Brain stem infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":874},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":864}]},{"term":"Diabetic retinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":874},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":864}]},{"term":"Duodenal ulcer haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":874},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":864}]},{"term":"Electric shock","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 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