{"protocolSection":{"identificationModule":{"nctId":"NCT03136484","orgStudyIdInfo":{"id":"NN9535-4270"},"secondaryIdInfos":[{"id":"2016-000989-35","type":"EUDRACT_NUMBER"},{"id":"U1111-1180-3651","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2016","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2016"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes","acronym":"SUSTAIN 8"},"statusModule":{"statusVerifiedDate":"2020-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-03-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-10-16","type":"ACTUAL"},"completionDateStruct":{"date":"2018-11-16","type":"ACTUAL"},"studyFirstSubmitDate":"2017-03-14","studyFirstSubmitQcDate":"2017-04-26","studyFirstPostDateStruct":{"date":"2017-05-02","type":"ACTUAL"},"resultsFirstSubmitDate":"2019-10-15","resultsFirstSubmitQcDate":"2019-11-28","resultsFirstPostDateStruct":{"date":"2019-12-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-01-08","lastUpdatePostDateStruct":{"date":"2020-01-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin"},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":788,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide + canagliflozin placebo","type":"EXPERIMENTAL","interventionNames":["Drug: Semaglutide","Drug: Placebo (canagliflozin)"]},{"label":"Canagliflozin + semaglutide placebo","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Canagliflozin","Drug: Placebo (semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.","armGroupLabels":["Semaglutide + canagliflozin placebo"]},{"type":"DRUG","name":"Canagliflozin","description":"Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.","armGroupLabels":["Canagliflozin + semaglutide placebo"]},{"type":"DRUG","name":"Placebo (canagliflozin)","description":"Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.","armGroupLabels":["Semaglutide + canagliflozin placebo"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.","armGroupLabels":["Canagliflozin + semaglutide placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c","description":"Change from baseline (week 0) to week 52 in HbA1c (glycosylated haemoglobin) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first; and 'In-trial' observation period which started at the date of randomisation and include the period after initiation of rescue medication and/or premature trial product discontinuation, if any and ended at the last contact, withdrawal of consent or death, whichever came first.","timeFrame":"Week 0, week 52"}],"secondaryOutcomes":[{"measure":"Change in Body Weight (kg)","description":"Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Total Fat Mass (kg)","description":"Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in FPG (Fasting Plasma Glucose)","description":"Change from baseline (week 0) to week 52 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile","description":"Change from baseline (week 0) to week 52 in SMPG- mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in SMPG- Mean Postprandial Increment Over All Meals","description":"Change from baseline (week 0) to week 52 in SMPG- mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Fasting Total Cholesterol","description":"Change from baseline (week 0) to week 52 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Fasting LDL-cholesterol","description":"Change from baseline (week 0) to week 52 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Fasting HDL-cholesterol","description":"Change from baseline (week 0) to week 52 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Fasting Triglycerides","description":"Change from baseline (week 0) to week 52 in fasting triglycerides (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)","description":"Change from baseline (week 0) to week 52 in systolic blood pressure and diastolic blood pressure. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Percentage Change in Body Weight (%)","description":"Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Body Mass Index (BMI)","description":"Change from baseline (week 0) to week 52 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Waist Circumference","description":"Change from baseline (week 0) to week 52 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Percentage Change in Total Fat Mass (%)","description":"Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Total Lean Mass (kg)","description":"Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Percentage Change in Total Lean Mass (%)","description":"Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Visceral Fat Mass (kg)","description":"Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Percentage Change in Visceral Fat Mass (%)","description":"Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Change in Ratio Between Total Fat Mass and Total Lean Mass","description":"Change from baseline (week 0) to week 52 in ratio between total fat mass and total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)","description":"Percentage of participants who achieved HbA1c \\< 7.0% (53 millimoles per mole \\[mmol/mol\\]), ADA target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 52"},{"measure":"Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)","description":"Percentage of participants who achieved HbA1c ≤ 6.5% (48 mmol/mol), AACE target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 52"},{"measure":"Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)","description":"Percentage of participants who achieved ≥1% reduction of baseline HbA1c (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Participants Who Achieved Weight Loss ≥3% (Yes/no)","description":"Percentage of participants losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Participants Who Achieved Weight Loss ≥5% (Yes/no)","description":"Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Participants Who Achieved Weight Loss ≥10% (Yes/no)","description":"Percentage of participants losing ≥10% of baseline body weight is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)","description":"Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \\<3.1 mmol/L (56 milligrams per deciliter \\[mg/dL\\]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)","description":"Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)","description":"Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)","description":"Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","timeFrame":"Week 0, week 52"},{"measure":"Total Number of Treatment Emergent Adverse Events (TEAEs)","description":"A TEAE is defined as an adverse event with onset in the on-treatment observation period (which started at the date of first dose of trial product and included the period after initiation of rescue medication, if any and excluded the period after premature trial product discontinuation, if any. TEAEs assessed up to approximately 57 weeks is presented.","timeFrame":"Weeks 0-57"},{"measure":"Change in Haematological Parameter- Haemoglobin","description":"Change from baseline (week 0) to week 52 in haemoglobin (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Haematological Parameter- Haematocrit","description":"Change from baseline (week 0) to week 52 in haematocrit (%) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Haematological Parameter- Erythrocytes","description":"Change from baseline (week 0) to week 52 in erythrocytes (10\\^12 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Haematological Parameter- Leukocytes","description":"Change from baseline (week 0) to week 52 in leukocytes (10\\^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Haematological Parameter- Thrombocytes","description":"Change from baseline (week 0) to week 52 in thrombocytes (10\\^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- Amylase","description":"Change from baseline (week 0) to week 52 in amylase (units per liter \\[U/L\\]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- Lipase","description":"Change from baseline (week 0) to week 52 in lipase (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- ALT","description":"Change from baseline (week 0) to week 52 in alanine aminotransferase (ALT) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- AST","description":"Change from baseline (week 0) to week 52 in aspartate aminotransferase (AST) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- ALP","description":"Change from baseline (week 0) to week 52 in alkaline phosphatase (ALP) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- Total Bilirubin","description":"Change from baseline (week 0) to week 52 in total bilirubin (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- Creatinine","description":"Change from baseline (week 0) to week 52 in creatinine (micromoles per liter \\[umol/L\\]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- eGFR","description":"Estimated glomerular filtration rate (eGFR) (milliliters per minute per 1.73 square meters \\[mL/min/1.73m\\^2\\])is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Change from baseline (week 0) to week 52 in eGFR is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- Albumin","description":"Change from baseline (week 0) to week 52 in albumin (g/dL) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- Calcium","description":"Change from baseline (week 0) to week 52 in calcium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- Potassium","description":"Change from baseline (week 0) to week 52 in potassium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Biochemistry Parameter- Sodium","description":"Change from baseline (week 0) to week 52 in sodium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Calcitonin","description":"Change from baseline (week 0) to week 52 in calcitonin (nanograms per liter) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Pulse","description":"Change from baseline (week 0) to week 52 in pulse is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in ECG","description":"The electrocardiogram (ECG) was assessed by the investigator at baseline (week 0) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Change in Physical Examination","description":"Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 52 is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week -2, week 52"},{"measure":"Eye Examination","description":"Fundus photography or a dilated fundoscopy was performed by the investigator at baseline (week 0) and week 52. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Week 0, week 52"},{"measure":"Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes","description":"Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Weeks 0-57"},{"measure":"Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes","description":"Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","timeFrame":"Weeks 0-57"},{"measure":"Change in Short Form 36 Health Survey (SF-36): Sub-domains","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) to week 52 in the sub-domain scores is presented. A positive change score indicate an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.","timeFrame":"Week 0, week 52"},{"measure":"Change in SF-36: Physical Component Summary (PCS)","description":"Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain PCS. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.","timeFrame":"Week 0, week 52"},{"measure":"Change in SF-36: Mental Component Summary (MCS)","description":"Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain MCS. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.","timeFrame":"Week 0, week 52"},{"measure":"Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately","description":"Change from baseline (week 0) in DTSQ was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period.","timeFrame":"Week 0, week 52"},{"measure":"Change in Control of Eating Questionnaire (CoEQ): Domains","description":"The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period.","timeFrame":"Week 0, week 52"},{"measure":"Change in CoEQ: Individual Items","description":"The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period.","timeFrame":"Week 0, week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age equal to or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose of metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject medical record and in compliance with current local label) for at least 90 days prior to the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening - Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis (DKA) - Any of the following: myocardial infarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as eGFR below 60 ml/min/1.73 m\\^2 as defined by Kidney Disease Improving global outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed - Medical history of diabetes-related lower limb amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to screening","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Novo Nordisk Investigational Site","city":"La Mesa","state":"California","zip":"91942","country":"United States","geoPoint":{"lat":32.76783,"lon":-117.02308}},{"facility":"Novo Nordisk Investigational Site","city":"Los Angeles","state":"California","zip":"90057","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Novo Nordisk Investigational 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Catarig AM, Frias JP, Kumar H, Lausvig NL, le Roux CW, Thielke D, Viljoen A, McCrimmon RJ. Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Nov;7(11):834-844. doi: 10.1016/S2213-8587(19)30311-0. Epub 2019 Sep 17."},{"pmid":"31897524","type":"RESULT","citation":"McCrimmon RJ, Catarig AM, Frias JP, Lausvig NL, le Roux CW, Thielke D, Lingvay I. Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial. Diabetologia. 2020 Mar;63(3):473-485. doi: 10.1007/s00125-019-05065-8. Epub 2020 Jan 2."},{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."},{"pmid":"37178435","type":"DERIVED","citation":"Pulleyblank R, Larsen NB. Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study. Pharmacoecon Open. 2023 Jul;7(4):579-591. doi: 10.1007/s41669-023-00416-z. Epub 2023 May 13."},{"pmid":"32827435","type":"DERIVED","citation":"Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Study design: Body composition (sub-study) was measured using dual x-ray absorptiometry (DXA) scans in a planned subset of randomised participants.","recruitmentDetails":"The trial was conducted at 115 sites in Argentina (5), Brazil (2), Canada (8), India (10), Ireland (4), Lebanon (5), Malaysia (5), Mexico (2), Sweden (5), United Kingdom (11) and United States (58).","groups":[{"id":"FG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"FG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"394"},{"groupId":"FG001","numSubjects":"394"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"392"},{"groupId":"FG001","numSubjects":"394"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"367"},{"groupId":"FG001","numSubjects":"372"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"22"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"14"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"BG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"394"},{"groupId":"BG001","value":"394"},{"groupId":"BG002","value":"788"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.7","spread":"11.1"},{"groupId":"BG001","value":"57.5","spread":"10.7"},{"groupId":"BG002","value":"56.6","spread":"10.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"171"},{"groupId":"BG001","value":"193"},{"groupId":"BG002","value":"364"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"223"},{"groupId":"BG001","value":"201"},{"groupId":"BG002","value":"424"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"156"},{"groupId":"BG001","value":"137"},{"groupId":"BG002","value":"293"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"238"},{"groupId":"BG001","value":"257"},{"groupId":"BG002","value":"495"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Race : American Indian or Alaska native","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"}]}]},{"title":"Race : Asian","categories":[{"measurements":[{"groupId":"BG000","value":"62"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"125"}]}]},{"title":"Race : Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"58"}]}]},{"title":"Race : Native Hawaiian or Other Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]},{"title":"Race : White","categories":[{"measurements":[{"groupId":"BG000","value":"297"},{"groupId":"BG001","value":"290"},{"groupId":"BG002","value":"587"}]}]},{"title":"Race : Other","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"13"}]}]},{"title":"Race : Not Applicable","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"HbA1c","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage (%) of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.3","spread":"1.0"},{"groupId":"BG001","value":"8.2","spread":"1.0"},{"groupId":"BG002","value":"8.3","spread":"1.0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c","description":"Change from baseline (week 0) to week 52 in HbA1c (glycosylated haemoglobin) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first; and 'In-trial' observation period which started at the date of randomisation and include the period after initiation of rescue medication and/or premature trial product discontinuation, if any and ended at the last contact, withdrawal of consent or death, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage (%) of HbA1c","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"313"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.7","spread":"1.1"},{"groupId":"OG001","value":"-1.0","spread":"1.0"}]}]},{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"362"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"1.3"},{"groupId":"OG001","value":"-1.0","spread":"1.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The responses were analysed using an analysis of covariance (ANCOVA) with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3 rather than zero as in a superiority test.","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.65","ciUpperLimit":"-0.33","estimateComment":"Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"The responses were analysed using an ANCOVA with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.65","ciUpperLimit":"-0.33","estimateComment":"Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo"}]},{"type":"SECONDARY","title":"Change in Body Weight (kg)","description":"Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (kg)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.7","spread":"5.4"},{"groupId":"OG001","value":"-4.3","spread":"4.0"}]}]}]},{"type":"SECONDARY","title":"Change in Total Fat Mass (kg)","description":"Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Dual X-ray absorptiometry (DXA) analysis set comprised of all randomised participants who are included in the body composition sub-study. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.72","spread":"4.50"},{"groupId":"OG001","value":"-2.63","spread":"3.30"}]}]}]},{"type":"SECONDARY","title":"Change in FPG (Fasting Plasma Glucose)","description":"Change from baseline (week 0) to week 52 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per liter (mmol/L)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.54","spread":"2.77"},{"groupId":"OG001","value":"-2.00","spread":"2.53"}]}]}]},{"type":"SECONDARY","title":"Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile","description":"Change from baseline (week 0) to week 52 in SMPG- mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.8","spread":"2.3"},{"groupId":"OG001","value":"-1.9","spread":"2.7"}]}]}]},{"type":"SECONDARY","title":"Change in SMPG- Mean Postprandial Increment Over All Meals","description":"Change from baseline (week 0) to week 52 in SMPG- mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"2.1"},{"groupId":"OG001","value":"-0.6","spread":"2.0"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Total Cholesterol","description":"Change from baseline (week 0) to week 52 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"19.3"},{"groupId":"OG001","value":"1.03","spread":"18.2"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting LDL-cholesterol","description":"Change from baseline (week 0) to week 52 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL-cholesterol","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"32.2"},{"groupId":"OG001","value":"1.05","spread":"29.0"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting HDL-cholesterol","description":"Change from baseline (week 0) to week 52 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL-cholesterol","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"13.1"},{"groupId":"OG001","value":"1.08","spread":"13.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Triglycerides","description":"Change from baseline (week 0) to week 52 in fasting triglycerides (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.86","spread":"40.6"},{"groupId":"OG001","value":"0.92","spread":"38.2"}]}]}]},{"type":"SECONDARY","title":"Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)","description":"Change from baseline (week 0) to week 52 in systolic blood pressure and diastolic blood pressure. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"title":"Systolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"298"},{"groupId":"OG001","value":"313"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.7","spread":"14.0"},{"groupId":"OG001","value":"-5.8","spread":"13.5"}]}]},{"title":"Diastolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"298"},{"groupId":"OG001","value":"313"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"9.8"},{"groupId":"OG001","value":"-2.9","spread":"9.0"}]}]}]},{"type":"SECONDARY","title":"Percentage Change in Body Weight (%)","description":"Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.2","spread":"6.1"},{"groupId":"OG001","value":"-4.7","spread":"4.0"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index (BMI)","description":"Change from baseline (week 0) to week 52 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram per square meter (kg/m^2)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"2.0"},{"groupId":"OG001","value":"-1.5","spread":"1.4"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change from baseline (week 0) to week 52 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter (cm)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"6.2"},{"groupId":"OG001","value":"-3.0","spread":"5.4"}]}]}]},{"type":"SECONDARY","title":"Percentage Change in Total Fat Mass (%)","description":"Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.55","spread":"2.76"},{"groupId":"OG001","value":"-1.21","spread":"2.64"}]}]}]},{"type":"SECONDARY","title":"Change in Total Lean Mass (kg)","description":"Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.06","spread":"2.15"},{"groupId":"OG001","value":"-1.53","spread":"2.21"}]}]}]},{"type":"SECONDARY","title":"Percentage Change in Total Lean Mass (%)","description":"Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.38","spread":"2.66"},{"groupId":"OG001","value":"1.09","spread":"2.56"}]}]}]},{"type":"SECONDARY","title":"Change in Visceral Fat Mass (kg)","description":"Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.20","spread":"0.40"},{"groupId":"OG001","value":"-0.13","spread":"0.32"}]}]}]},{"type":"SECONDARY","title":"Percentage Change in Visceral Fat Mass (%)","description":"Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.81","spread":"7.30"},{"groupId":"OG001","value":"0.16","spread":"4.36"}]}]}]},{"type":"SECONDARY","title":"Change in Ratio Between Total Fat Mass and Total Lean Mass","description":"Change from baseline (week 0) to week 52 in ratio between total fat mass and total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"total fat mass/total lean mass ratio","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.04","spread":"0.08"},{"groupId":"OG001","value":"-0.03","spread":"0.07"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)","description":"Percentage of participants who achieved HbA1c \\< 7.0% (53 millimoles per mole \\[mmol/mol\\]), ADA target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"76.1"},{"groupId":"OG001","value":"50.8"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"23.9"},{"groupId":"OG001","value":"49.2"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)","description":"Percentage of participants who achieved HbA1c ≤ 6.5% (48 mmol/mol), AACE target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"62.1"},{"groupId":"OG001","value":"26.8"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"37.9"},{"groupId":"OG001","value":"73.2"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)","description":"Percentage of participants who achieved ≥1% reduction of baseline HbA1c (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"76.5"},{"groupId":"OG001","value":"48.6"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"23.5"},{"groupId":"OG001","value":"51.4"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved Weight Loss ≥3% (Yes/no)","description":"Percentage of participants losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"298"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"68.8"},{"groupId":"OG001","value":"64.9"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"31.2"},{"groupId":"OG001","value":"35.1"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved Weight Loss ≥5% (Yes/no)","description":"Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"298"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"52.7"},{"groupId":"OG001","value":"47.0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"47.3"},{"groupId":"OG001","value":"53.0"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved Weight Loss ≥10% (Yes/no)","description":"Percentage of participants losing ≥10% of baseline body weight is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"298"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"23.2"},{"groupId":"OG001","value":"8.9"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"76.8"},{"groupId":"OG001","value":"91.1"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)","description":"Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \\<3.1 mmol/L (56 milligrams per deciliter \\[mg/dL\\]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"69.6"},{"groupId":"OG001","value":"45.0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"30.4"},{"groupId":"OG001","value":"55.0"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)","description":"Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"57.3"},{"groupId":"OG001","value":"34.8"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"42.7"},{"groupId":"OG001","value":"65.2"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)","description":"Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"45.1"},{"groupId":"OG001","value":"25.9"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"54.9"},{"groupId":"OG001","value":"74.1"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)","description":"Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"313"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"21.8"},{"groupId":"OG001","value":"6.1"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"78.2"},{"groupId":"OG001","value":"93.9"}]}]}]},{"type":"SECONDARY","title":"Total Number of Treatment Emergent Adverse Events (TEAEs)","description":"A TEAE is defined as an adverse event with onset in the on-treatment observation period (which started at the date of first dose of trial product and included the period after initiation of rescue medication, if any and excluded the period after premature trial product discontinuation, if any. TEAEs assessed up to approximately 57 weeks is presented.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Adverse events","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1189"},{"groupId":"OG001","value":"1138"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Haemoglobin","description":"Change from baseline (week 0) to week 52 in haemoglobin (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of haemoglobin","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"8.0"},{"groupId":"OG001","value":"1.05","spread":"8.5"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Haematocrit","description":"Change from baseline (week 0) to week 52 in haematocrit (%) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of haematocrit","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"6.8"},{"groupId":"OG001","value":"1.04","spread":"6.9"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Erythrocytes","description":"Change from baseline (week 0) to week 52 in erythrocytes (10\\^12 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of erythrocytes","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"5.7"},{"groupId":"OG001","value":"1.04","spread":"6.0"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Leukocytes","description":"Change from baseline (week 0) to week 52 in leukocytes (10\\^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of leukocytes","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"20.3"},{"groupId":"OG001","value":"0.98","spread":"17.5"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Thrombocytes","description":"Change from baseline (week 0) to week 52 in thrombocytes (10\\^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of thrombocytes","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"14.4"},{"groupId":"OG001","value":"1.00","spread":"15.4"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Amylase","description":"Change from baseline (week 0) to week 52 in amylase (units per liter \\[U/L\\]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.16","spread":"26.5"},{"groupId":"OG001","value":"1.09","spread":"24.4"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Lipase","description":"Change from baseline (week 0) to week 52 in lipase (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.25","spread":"54.5"},{"groupId":"OG001","value":"1.01","spread":"51.5"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- ALT","description":"Change from baseline (week 0) to week 52 in alanine aminotransferase (ALT) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of ALT","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.79","spread":"49.5"},{"groupId":"OG001","value":"0.79","spread":"45.3"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- AST","description":"Change from baseline (week 0) to week 52 in aspartate aminotransferase (AST) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AST","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"37.5"},{"groupId":"OG001","value":"0.86","spread":"37.4"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- ALP","description":"Change from baseline (week 0) to week 52 in alkaline phosphatase (ALP) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of ALP","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"19.6"},{"groupId":"OG001","value":"0.95","spread":"16.8"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Total Bilirubin","description":"Change from baseline (week 0) to week 52 in total bilirubin (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total bilirubin","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"32.1"},{"groupId":"OG001","value":"1.13","spread":"33.9"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Creatinine","description":"Change from baseline (week 0) to week 52 in creatinine (micromoles per liter \\[umol/L\\]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of creatinine","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"11.0"},{"groupId":"OG001","value":"1.04","spread":"11.9"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- eGFR","description":"Estimated glomerular filtration rate (eGFR) (milliliters per minute per 1.73 square meters \\[mL/min/1.73m\\^2\\])is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Change from baseline (week 0) to week 52 in eGFR is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of eGFR","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"8.4"},{"groupId":"OG001","value":"0.96","spread":"9.7"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Albumin","description":"Change from baseline (week 0) to week 52 in albumin (g/dL) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of albumin","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"5.4"},{"groupId":"OG001","value":"1.00","spread":"5.2"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Calcium","description":"Change from baseline (week 0) to week 52 in calcium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of calcium","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"4.5"},{"groupId":"OG001","value":"1.02","spread":"4.1"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Potassium","description":"Change from baseline (week 0) to week 52 in potassium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of potassium","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"9.3"},{"groupId":"OG001","value":"1.00","spread":"8.6"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Sodium","description":"Change from baseline (week 0) to week 52 in sodium (mmol/L) is presented as ratio to baseline. 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Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"348"},{"groupId":"OG001","value":"358"}]}]},{"title":"Left leg (week -2) Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"30"}]}]},{"title":"Left leg (week -2) Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"6"}]}]},{"title":"Left leg (week 52) 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Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"357"}]}]},{"title":"Right leg (week -2) Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"30"}]}]},{"title":"Right leg (week -2) Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"}]}]},{"title":"Right leg (week 52) Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"339"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"315"}]}]},{"title":"Right leg (week 52) Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"339"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"21"}]}]},{"title":"Right leg (week 52) Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"339"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","title":"Eye Examination","description":"Fundus photography or a dilated fundoscopy was performed by the investigator at baseline (week 0) and week 52. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"title":"Left eye: Normal (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"393"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"322"},{"groupId":"OG001","value":"319"}]}]},{"title":"Left eye: Abnormal NCS (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"393"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"71"}]}]},{"title":"Left eye: Abnormal CS (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"393"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"}]}]},{"title":"Left eye: Normal (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"228"}]}]},{"title":"Left eye: Abnormal NCS (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"40"}]}]},{"title":"Left eye: Abnormal CS (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}]}]},{"title":"Right eye: Normal (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"393"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"321"},{"groupId":"OG001","value":"319"}]}]},{"title":"Right eye: Abnormal NCS (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"393"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"70"}]}]},{"title":"Right eye: Abnormal CS (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"393"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"}]}]},{"title":"Right eye: Normal (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"225"},{"groupId":"OG001","value":"226"}]}]},{"title":"Right eye: Abnormal NCS (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"44"}]}]},{"title":"Right eye: Abnormal CS (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes","description":"Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"6"}]}]}]},{"type":"SECONDARY","title":"Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes","description":"Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.","populationDescription":"Safety analysis set comprised of participants exposed to at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"392"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 Health Survey (SF-36): Sub-domains","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) to week 52 in the sub-domain scores is presented. A positive change score indicate an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"title":"Physical Functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"277"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.9","spread":"7.1"},{"groupId":"OG001","value":"2.7","spread":"6.7"}]}]},{"title":"Role-physical","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"277"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.8","spread":"7.3"},{"groupId":"OG001","value":"2.0","spread":"7.1"}]}]},{"title":"Bodily pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"277"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"8.9"},{"groupId":"OG001","value":"1.5","spread":"8.7"}]}]},{"title":"General health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"277"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.7","spread":"7.7"},{"groupId":"OG001","value":"3.5","spread":"8.5"}]}]},{"title":"Social functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"277"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"8.6"},{"groupId":"OG001","value":"1.1","spread":"8.0"}]}]},{"title":"Role-emotional","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"277"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"9.2"},{"groupId":"OG001","value":"1.2","spread":"8.6"}]}]},{"title":"Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"277"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.0","spread":"8.2"},{"groupId":"OG001","value":"2.0","spread":"8.2"}]}]},{"title":"Mental health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"277"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"8.3"},{"groupId":"OG001","value":"0.6","spread":"8.1"}]}]}]},{"type":"SECONDARY","title":"Change in SF-36: Physical Component Summary (PCS)","description":"Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain PCS. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.7","spread":"6.7"},{"groupId":"OG001","value":"2.9","spread":"6.2"}]}]}]},{"type":"SECONDARY","title":"Change in SF-36: Mental Component Summary (MCS)","description":"Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain MCS. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"8.8"},{"groupId":"OG001","value":"0.5","spread":"8.0"}]}]}]},{"type":"SECONDARY","title":"Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately","description":"Change from baseline (week 0) in DTSQ was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"title":"1) Satisfaction with treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"1.6"},{"groupId":"OG001","value":"1.0","spread":"1.6"}]}]},{"title":"2) Feeling of unacceptably high blood sugars","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"2.2"},{"groupId":"OG001","value":"-1.8","spread":"2.2"}]}]},{"title":"3) Feeling of unacceptably low blood sugars","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"1.9"},{"groupId":"OG001","value":"0.1","spread":"1.6"}]}]},{"title":"4) Convenience of treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"1.8"},{"groupId":"OG001","value":"0.7","spread":"1.8"}]}]},{"title":"5) Flexibility of current treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"1.7"},{"groupId":"OG001","value":"0.7","spread":"1.7"}]}]},{"title":"6) Satisfaction with understanding of diabetes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"1.5"},{"groupId":"OG001","value":"0.6","spread":"1.3"}]}]},{"title":"7) Recommending treatment to others","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"1.5"},{"groupId":"OG001","value":"0.9","spread":"1.5"}]}]},{"title":"8) Satisfaction to continue with present treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"1.8"},{"groupId":"OG001","value":"0.8","spread":"1.8"}]}]},{"title":"Total treatment satisfaction score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"280"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.8","spread":"7.0"},{"groupId":"OG001","value":"4.8","spread":"7.2"}]}]}]},{"type":"SECONDARY","title":"Change in Control of Eating Questionnaire (CoEQ): Domains","description":"The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"title":"Craving control","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"279"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"2.1"},{"groupId":"OG001","value":"1.0","spread":"2.5"}]}]},{"title":"Craving for sweet","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"279"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"2.2"},{"groupId":"OG001","value":"-0.6","spread":"2.1"}]}]},{"title":"Craving for savoury","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"279"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"2.0"},{"groupId":"OG001","value":"-0.9","spread":"2.0"}]}]},{"title":"Positive mood","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"279"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.7","spread":"1.7"},{"groupId":"OG001","value":"0.4","spread":"1.6"}]}]}]},{"type":"SECONDARY","title":"Change in CoEQ: Individual Items","description":"The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period.","populationDescription":"Full analysis set comprised of all randomised participants. \"Number analyzed\"=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Semaglutide + Canagliflozin Placebo","description":"Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks."},{"id":"OG001","title":"Canagliflozin + Semaglutide Placebo","description":"Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"394"}]}],"classes":[{"title":"How hungry have you felt","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"279"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"2.6"},{"groupId":"OG001","value":"-0.8","spread":"2.6"}]}]},{"title":"How full have you felt","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"279"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"2.7"},{"groupId":"OG001","value":"0.0","spread":"2.7"}]}]},{"title":"How often have you had cravings (last 7 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