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A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin. Diabetes Care. 2018 Sep;41(9):1926-1937. doi: 10.2337/dc17-2381. Epub 2018 Jul 19."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Of the 706 subjects randomised in the trial, 705 were exposed to trial products and 1 randomised subject withdrew prior to exposure.","recruitmentDetails":"The trial was conducted at 139 sites in 10 countries as follows:\n\nAustria: 3 sites; Canada: 8 sites; Czech Republic: 9 sites; Germany:\n\n7 sites; Malaysia: 5 sites; Russian Federation: 7 sites; Serbia: 9 sites; South Africa: 7 sites; United Kingdom: 13 sites; United States: 71 sites.","groups":[{"id":"FG000","title":"Semaglutide 0.05 mg/Day","description":"Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"FG001","title":"Semaglutide 0.1 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"FG002","title":"Semaglutide 0.2 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"FG003","title":"Semaglutide 0.3 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"FG004","title":"Liraglutide 0.3 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"FG005","title":"Liraglutide 0.6 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"FG006","title":"Liraglutide 1.2 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"FG007","title":"Liraglutide 1.8 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"FG008","title":"Placebo","description":"Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. 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Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"64"},{"groupId":"FG001","numSubjects":"63"},{"groupId":"FG002","numSubjects":"65"},{"groupId":"FG003","numSubjects":"63"},{"groupId":"FG004","numSubjects":"64"},{"groupId":"FG005","numSubjects":"64"},{"groupId":"FG006","numSubjects":"64"},{"groupId":"FG007","numSubjects":"65"},{"groupId":"FG008","numSubjects":"129"},{"groupId":"FG009","numSubjects":"65"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"64"},{"groupId":"FG001","numSubjects":"63"},{"groupId":"FG002","numSubjects":"65"},{"groupId":"FG003","numSubjects":"63"},{"groupId":"FG004","numSubjects":"64"},{"groupId":"FG005","numSubjects":"64"},{"groupId":"FG006","numSubjects":"64"},{"groupId":"FG007","numSubjects":"65"},{"groupId":"FG008","numSubjects":"129"},{"groupId":"FG009","numSubjects":"64"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"58"},{"groupId":"FG001","numSubjects":"61"},{"groupId":"FG002","numSubjects":"60"},{"groupId":"FG003","numSubjects":"58"},{"groupId":"FG004","numSubjects":"62"},{"groupId":"FG005","numSubjects":"61"},{"groupId":"FG006","numSubjects":"58"},{"groupId":"FG007","numSubjects":"60"},{"groupId":"FG008","numSubjects":"123"},{"groupId":"FG009","numSubjects":"60"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"6"},{"groupId":"FG007","numSubjects":"5"},{"groupId":"FG008","numSubjects":"6"},{"groupId":"FG009","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"3"},{"groupId":"FG008","numSubjects":"3"},{"groupId":"FG009","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"3"},{"groupId":"FG009","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"2"}]},{"type":"Missing follow-up information","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"}]},{"type":"Withdrawal from trial before exposure","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Analysis was performed on the full analysis set (FAS) which included all randomised subjects who had received at least 1 dose of either semaglutide, liraglutide or placebo.","groups":[{"id":"BG000","title":"Semaglutide 0.05 mg/Day","description":"Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. 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Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"BG007","title":"Liraglutide 1.8 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"BG008","title":"Placebo","description":"Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. 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pressure","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"80.06","spread":"8.90"},{"groupId":"BG001","value":"79.71","spread":"8.56"},{"groupId":"BG002","value":"80.48","spread":"8.87"},{"groupId":"BG003","value":"81.41","spread":"8.05"},{"groupId":"BG004","value":"81.83","spread":"6.98"},{"groupId":"BG005","value":"81.28","spread":"6.90"},{"groupId":"BG006","value":"82.98","spread":"6.94"},{"groupId":"BG007","value":"80.66","spread":"7.62"},{"groupId":"BG008","value":"80.98","spread":"8.00"},{"groupId":"BG009","value":"81.89","spread":"8.40"},{"groupId":"BG010","value":"81.11","spread":"7.96"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c (Glycosylated Haemoglobin)","description":"Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the \"on-treatment until rescue medication\" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of glycosylated haemoglobin","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Semaglutide 0.05 mg/Day","description":"Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG001","title":"Semaglutide 0.1 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG002","title":"Semaglutide 0.2 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG003","title":"Semaglutide 0.3 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG004","title":"Liraglutide 0.3 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG005","title":"Liraglutide 0.6 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG006","title":"Liraglutide 1.2 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG007","title":"Liraglutide 1.8 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG008","title":"Placebo","description":"Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG009","title":"Semaglutide Flexible","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"63"},{"groupId":"OG004","value":"64"},{"groupId":"OG005","value":"64"},{"groupId":"OG006","value":"64"},{"groupId":"OG007","value":"65"},{"groupId":"OG008","value":"129"},{"groupId":"OG009","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.97","spread":"0.85"},{"groupId":"OG001","value":"-1.30","spread":"1.03"},{"groupId":"OG002","value":"-1.65","spread":"0.79"},{"groupId":"OG003","value":"-1.96","spread":"0.95"},{"groupId":"OG004","value":"-0.50","spread":"0.93"},{"groupId":"OG005","value":"-0.88","spread":"0.90"},{"groupId":"OG006","value":"-0.86","spread":"0.92"},{"groupId":"OG007","value":"-1.32","spread":"0.78"},{"groupId":"OG008","value":"-0.05","spread":"0.90"},{"groupId":"OG009","value":"-1.72","spread":"0.97"}]}]}],"analyses":[{"groupIds":["OG000","OG008"],"nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.30","ciUpperLimit":"-0.77"},{"groupIds":["OG001","OG008"],"nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.61","ciUpperLimit":"-1.08"},{"groupIds":["OG002","OG008"],"nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.69","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.95","ciUpperLimit":"-1.42"},{"groupIds":["OG003","OG008"],"nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-1.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.12","ciUpperLimit":"-1.60"}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"Estimated mean change from baseline in FPG at week 26. The data were analysed for the \"on-treatment until rescue medication\" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.","populationDescription":"Full analyses set. For \"Semaglutide flexible arm\", data was available only for 63 subjects.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Semaglutide 0.05 mg/Day","description":"Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG001","title":"Semaglutide 0.1 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG002","title":"Semaglutide 0.2 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG003","title":"Semaglutide 0.3 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG004","title":"Liraglutide 0.3 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG005","title":"Liraglutide 0.6 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG006","title":"Liraglutide 1.2 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG007","title":"Liraglutide 1.8 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG008","title":"Placebo","description":"Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG009","title":"Semaglutide Flexible","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"63"},{"groupId":"OG004","value":"64"},{"groupId":"OG005","value":"64"},{"groupId":"OG006","value":"64"},{"groupId":"OG007","value":"65"},{"groupId":"OG008","value":"129"},{"groupId":"OG009","value":"63"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.09","spread":"1.96"},{"groupId":"OG001","value":"-2.08","spread":"2.23"},{"groupId":"OG002","value":"-2.64","spread":"2.07"},{"groupId":"OG003","value":"-3.53","spread":"2.20"},{"groupId":"OG004","value":"-1.33","spread":"2.06"},{"groupId":"OG005","value":"-1.56","spread":"1.74"},{"groupId":"OG006","value":"-1.51","spread":"2.41"},{"groupId":"OG007","value":"-1.92","spread":"2.34"},{"groupId":"OG008","value":"-0.54","spread":"2.45"},{"groupId":"OG009","value":"-3.40","spread":"2.84"}]}]}]},{"type":"SECONDARY","title":"Body Weight Change","description":"The data were analysed for the \"on-treatment until rescue medication\" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Semaglutide 0.05 mg/Day","description":"Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG001","title":"Semaglutide 0.1 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG002","title":"Semaglutide 0.2 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG003","title":"Semaglutide 0.3 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG004","title":"Liraglutide 0.3 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG005","title":"Liraglutide 0.6 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG006","title":"Liraglutide 1.2 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG007","title":"Liraglutide 1.8 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG008","title":"Placebo","description":"Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG009","title":"Semaglutide Flexible","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"63"},{"groupId":"OG004","value":"64"},{"groupId":"OG005","value":"64"},{"groupId":"OG006","value":"64"},{"groupId":"OG007","value":"65"},{"groupId":"OG008","value":"129"},{"groupId":"OG009","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.75","spread":"2.82"},{"groupId":"OG001","value":"-4.36","spread":"4.24"},{"groupId":"OG002","value":"-6.70","spread":"4.57"},{"groupId":"OG003","value":"-8.23","spread":"5.34"},{"groupId":"OG004","value":"-1.48","spread":"3.06"},{"groupId":"OG005","value":"-1.81","spread":"3.06"},{"groupId":"OG006","value":"-1.78","spread":"3.41"},{"groupId":"OG007","value":"-3.68","spread":"4.26"},{"groupId":"OG008","value":"-1.22","spread":"3.42"},{"groupId":"OG009","value":"-6.60","spread":"4.98"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic and Diastolic Blood Pressure","description":"The data were analysed for the \"on-treatment until rescue medication\" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Semaglutide 0.05 mg/Day","description":"Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG001","title":"Semaglutide 0.1 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG002","title":"Semaglutide 0.2 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG003","title":"Semaglutide 0.3 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG004","title":"Liraglutide 0.3 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG005","title":"Liraglutide 0.6 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG006","title":"Liraglutide 1.2 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG007","title":"Liraglutide 1.8 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG008","title":"Placebo","description":"Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals."},{"id":"OG009","title":"Semaglutide Flexible","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"63"},{"groupId":"OG004","value":"64"},{"groupId":"OG005","value":"64"},{"groupId":"OG006","value":"64"},{"groupId":"OG007","value":"65"},{"groupId":"OG008","value":"129"},{"groupId":"OG009","value":"64"}]}],"classes":[{"title":"Systolicblood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-5.74","spread":"12.30"},{"groupId":"OG001","value":"-2.77","spread":"13.21"},{"groupId":"OG002","value":"-4.25","spread":"12.24"},{"groupId":"OG003","value":"-9.85","spread":"11.58"},{"groupId":"OG004","value":"-3.77","spread":"9.79"},{"groupId":"OG005","value":"-3.20","spread":"10.89"},{"groupId":"OG006","value":"-4.69","spread":"12.73"},{"groupId":"OG007","value":"-2.99","spread":"11.94"},{"groupId":"OG008","value":"-2.34","spread":"11.40"},{"groupId":"OG009","value":"-6.62","spread":"14.02"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-0.60","spread":"8.78"},{"groupId":"OG001","value":"0.66","spread":"8.26"},{"groupId":"OG002","value":"-1.62","spread":"9.38"},{"groupId":"OG003","value":"-4.02","spread":"8.56"},{"groupId":"OG004","value":"-1.77","spread":"7.37"},{"groupId":"OG005","value":"-1.89","spread":"8.20"},{"groupId":"OG006","value":"-0.60","spread":"6.78"},{"groupId":"OG007","value":"0.63","spread":"8.13"},{"groupId":"OG008","value":"-0.61","spread":"8.50"},{"groupId":"OG009","value":"-1.69","spread":"8.25"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline up to week 33.","description":"Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation \"as treated\". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).","eventGroups":[{"id":"EG000","title":"Semaglutide 0.05 mg/Day","description":"Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.","seriousNumAffected":7,"seriousNumAtRisk":64,"otherNumAffected":31,"otherNumAtRisk":64},{"id":"EG001","title":"Semaglutide 0.1 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.","seriousNumAffected":3,"seriousNumAtRisk":63,"otherNumAffected":34,"otherNumAtRisk":63},{"id":"EG002","title":"Semaglutide 0.2 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.","seriousNumAffected":2,"seriousNumAtRisk":65,"otherNumAffected":39,"otherNumAtRisk":65},{"id":"EG003","title":"Semaglutide 0.3 mg/Day","description":"Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.","seriousNumAffected":2,"seriousNumAtRisk":63,"otherNumAffected":42,"otherNumAtRisk":63},{"id":"EG004","title":"Liraglutide 0.3 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.","seriousNumAffected":1,"seriousNumAtRisk":64,"otherNumAffected":33,"otherNumAtRisk":64},{"id":"EG005","title":"Liraglutide 0.6 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.","seriousNumAffected":2,"seriousNumAtRisk":64,"otherNumAffected":27,"otherNumAtRisk":64},{"id":"EG006","title":"Liraglutide 1.2 mg/Day","description":"Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. 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