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Missing values were imputed using mixed model for repeated measurements (MMRM).","timeFrame":"From baseline to week 26"}],"secondaryOutcomes":[{"measure":"Change in Body Weight","description":"Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.","timeFrame":"From baseline to week 26"},{"measure":"Change in Fasting Plasma Glucose","description":"Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. 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Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial. Diabetes Obes Metab. 2016 Dec;18(12):1191-1198. doi: 10.1111/dom.12736. Epub 2016 Sep 14."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Screening details: Subjects were adult males or females with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control with stable doses of sitagliptin and metformin for 90 days prior to screening.","recruitmentDetails":"The trial was conducted at 86 sites in 6 countries: Canada (14); Hungary (8); India (7); Israel (8); Spain (6); and United States (43).","groups":[{"id":"FG000","title":"Liraglutide","description":"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \\[under the skin\\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose\n\n≥1000 mg/day\\]) + OD sitagliptin placebo tablets."},{"id":"FG001","title":"Sitagliptin","description":"Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose ≥1000 mg/day\\]) + OD s.c., injection of liraglutide placebo."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"203"},{"groupId":"FG001","numSubjects":"204"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","comment":"One subject in lira arm was not exposed (Reason: withdrawal by subject)","numSubjects":"202"},{"groupId":"FG001","numSubjects":"204"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"187"},{"groupId":"FG001","numSubjects":"191"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"13"}]}],"dropWithdraws":[{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Demographics and baseline characteristics of all exposed subjects are summarised in continuous variables. There were missing baseline values for fasting plasma glucose in 2 subjects in the liraglutide arm and 1 subject in the sitagliptin arm.","groups":[{"id":"BG000","title":"Liraglutide","description":"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \\[under the skin\\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose\n\n≥1000 mg/day\\]) + OD sitagliptin placebo tablets."},{"id":"BG001","title":"Sitagliptin","description":"Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose ≥1000 mg/day\\]) + OD s.c., injection of liraglutide placebo."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"202"},{"groupId":"BG001","value":"204"},{"groupId":"BG002","value":"406"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.3","spread":"10.6"},{"groupId":"BG001","value":"56.5","spread":"9.7"},{"groupId":"BG002","value":"56.4","spread":"10.2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"85"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"164"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"117"},{"groupId":"BG001","value":"125"},{"groupId":"BG002","value":"242"}]}]}]},{"title":"HbA1c","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated haemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.3","spread":"0.6"},{"groupId":"BG001","value":"8.2","spread":"0.6"},{"groupId":"BG002","value":"8.3","spread":"0.6"}]}]}]},{"title":"Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"88.9","spread":"19.8"},{"groupId":"BG001","value":"91.2","spread":"19.6"},{"groupId":"BG002","value":"90.1","spread":"19.7"}]}]}]},{"title":"Fasting Plasma Glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10.0","spread":"2.7"},{"groupId":"BG001","value":"9.7","spread":"2.5"},{"groupId":"BG002","value":"9.9","spread":"2.6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c (Glycosylated Haemoglobin)","description":"Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).","populationDescription":"Full analysis set (FAS) -All randomised subjects receiving at least one dose of any of the trial product.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of glycosylated haemoglobin","timeFrame":"From baseline to week 26","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \\[under the skin\\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose\n\n≥1000 mg/day\\]) + OD sitagliptin placebo tablets."},{"id":"OG001","title":"Sitagliptin","description":"Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose ≥1000 mg/day\\]) + OD s.c., injection of liraglutide placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"182"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.146","spread":"0.9748"},{"groupId":"OG001","value":"-0.529","spread":"1.0148"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Changes in HbA1c from baseline to the 26 weeks measurements were analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \\>8.5%), metformin dose (\\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the HbA1c value at baseline as a covariate, all variables nested within week as a factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.","paramType":"Treatment difference","paramValue":"-0.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.82","ciUpperLimit":"-0.40"}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.","populationDescription":"FAS - All randomised subjects receiving at least one dose of any of the trial product.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"From baseline to week 26","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \\[under the skin\\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose\n\n≥1000 mg/day\\]) + OD sitagliptin placebo tablets."},{"id":"OG001","title":"Sitagliptin","description":"Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose ≥1000 mg/day\\]) + OD s.c., injection of liraglutide placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"192"},{"groupId":"OG001","value":"200"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.32","spread":"3.135"},{"groupId":"OG001","value":"-1.80","spread":"2.974"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in body weight from baseline to the 26 weeks measurements was analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \\>8.5%), metformin dose (\\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the body weight at baseline as a covariate and all variables nested within week as a factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.","paramType":"Treatment difference","paramValue":"-1.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.34","ciUpperLimit":"-0.99"}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose","description":"Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.","populationDescription":"FAS - All randomised subjects receiving at least one dose of any of the trial product.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nmol/L","timeFrame":"From baseline to week 26","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \\[under the skin\\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose\n\n≥1000 mg/day\\]) + OD sitagliptin placebo tablets."},{"id":"OG001","title":"Sitagliptin","description":"Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose ≥1000 mg/day\\]) + OD s.c., injection of liraglutide placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"190"},{"groupId":"OG001","value":"199"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.967","spread":"2.3585"},{"groupId":"OG001","value":"-0.588","spread":"2.1363"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Blood Lipids","description":"Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein \\[LDL\\], very low density lipoprotein \\[VLDL\\], high density lipoprotein \\[HDL\\], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.","populationDescription":"FAS-All randomised subjects receiving at least one dose of any of the trial product. There were missing baseline values for free fatty acids in 1 subject in the liraglutide arm and 6 subjects in the sitagliptin arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ratio","timeFrame":"From baseline to week 26","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \\[under the skin\\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose\n\n≥1000 mg/day\\]) + OD sitagliptin placebo tablets."},{"id":"OG001","title":"Sitagliptin","description":"Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose ≥1000 mg/day\\]) + OD s.c., injection of liraglutide placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"156"}]}],"classes":[{"title":"Total cholesterol","categories":[{"measurements":[{"groupId":"OG000","value":"1.011","spread":"0.1906"},{"groupId":"OG001","value":"1.045","spread":"0.2323"}]}]},{"title":"LDL cholesterol","categories":[{"measurements":[{"groupId":"OG000","value":"1.049","spread":"0.3899"},{"groupId":"OG001","value":"1.121","spread":"0.4661"}]}]},{"title":"VLDL cholesterol","categories":[{"measurements":[{"groupId":"OG000","value":"1.062","spread":"0.4236"},{"groupId":"OG001","value":"1.075","spread":"0.4625"}]}]},{"title":"HDL cholesterol","categories":[{"measurements":[{"groupId":"OG000","value":"1.004","spread":"0.1528"},{"groupId":"OG001","value":"0.997","spread":"0.1548"}]}]},{"title":"Triglycerides","categories":[{"measurements":[{"groupId":"OG000","value":"1.089","spread":"0.4975"},{"groupId":"OG001","value":"1.099","spread":"0.4889"}]}]},{"title":"Free Fatty acids","categories":[{"measurements":[{"groupId":"OG000","value":"1.086","spread":"0.774"},{"groupId":"OG001","value":"1.104","spread":"0.5839"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure and Diastolic Blood Pressure","description":"Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.","populationDescription":"FAS - All randomised subjects receiving at least one dose of any of the trial product","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"From baseline to week 26","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \\[under the skin\\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose\n\n≥1000 mg/day\\]) + OD sitagliptin placebo tablets."},{"id":"OG001","title":"Sitagliptin","description":"Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose ≥1000 mg/day\\]) + OD s.c., injection of liraglutide placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"192"},{"groupId":"OG001","value":"200"}]}],"classes":[{"title":"Systolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-3.6","spread":"11.596"},{"groupId":"OG001","value":"-2.57","spread":"11.593"}]}]},{"title":"Diastolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-0.23","spread":"7.085"},{"groupId":"OG001","value":"-0.81","spread":"7.193"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)","description":"Number of subjects who achieve HbA1c \\<7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.","populationDescription":"FAS-All randomised subjects receiving at least one dose of any of the trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage (%)","timeFrame":"After 26 weeks of treatment","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \\[under the skin\\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose\n\n≥1000 mg/day\\]) + OD sitagliptin placebo tablets."},{"id":"OG001","title":"Sitagliptin","description":"Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \\[or documented maximum tolerated dose ≥1000 mg/day\\]) + OD s.c., injection of liraglutide placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"182"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"50.6"},{"groupId":"OG001","value":"26.9"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"49.4"},{"groupId":"OG001","value":"73.1"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. 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18.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":18,"numAffected":15,"numAtRisk":202},{"groupId":"EG001","numEvents":15,"numAffected":10,"numAtRisk":204}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 18.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":12,"numAtRisk":202},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":204}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 18.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":12,"numAtRisk":202},{"groupId":"EG001","numEvents":15,"numAffected":13,"numAtRisk":204}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA version 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collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property. The results of this trial will be subject to public disclosure on external web sites according to international regulations, as reflected in the Novo Nordisk Code of Conduct for Clinical Trial Disclosure."},"pointOfContact":{"title":"Public Access to Clinical Trials","organization":"Novo Nordisk A/S","email":"clinicaltrials@novonordisk.com"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069450","term":"Liraglutide"},{"id":"D000068900","term":"Sitagliptin Phosphate"}],"ancestors":[{"id":"D052216","term":"Glucagon-Like Peptide 1"},{"id":"D004763","term":"Glucagon-Like Peptides"},{"id":"D052336","term":"Proglucagon"},{"id":"D005768","term":"Gastrointestinal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"},{"id":"D014230","term":"Triazoles"},{"id":"D001393","term":"Azoles"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011719","term":"Pyrazines"}]}},"hasResults":true}