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Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial. Diabetes Care. 2018 May;41(5):1009-1016. doi: 10.2337/dc17-1114. Epub 2018 Feb 26."},{"pmid":"32107930","type":"DERIVED","citation":"Billings LK, Agner BFR, Altuntas Y, Gron R, Halladin N, Klonoff DC, Tentolouris N, Jodar E. The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial. J Diabetes Sci Technol. 2021 May;15(3):636-645. doi: 10.1177/1932296820906888. Epub 2020 Feb 28."},{"pmid":"31705547","type":"DERIVED","citation":"Meneghini L, Doshi A, Gouet D, Vilsboll T, Begtrup K, Orsy P, Ranthe MF, Lingvay I. Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin. Diabet Med. 2020 Feb;37(2):267-276. doi: 10.1111/dme.14178. Epub 2019 Nov 28."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects with type 2 diabetes mellitus were on treatment with stable daily dose of insulin glargine (IGlar) between 20 units and 50 units (both inclusive) for at least 56 days prior to screening in combination with a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) for at least 90 days prior to screening.","recruitmentDetails":"The trial was conducted at 89 sites in 12 countries: Argentina (3 sites), Czech Republic (5 sites), France (3 sites), Greece (6 sites), Hungary (3 sites), Israel (6 sites), Mexico (3 sites), Russia (7 sites), Slovakia (5 sites), Spain (6 sites), Turkey (5 sites) and United States (37 sites).","groups":[{"id":"FG000","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern."},{"id":"FG001","title":"IGlar + IAsp","description":"Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"252"},{"groupId":"FG001","numSubjects":"254"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"252"},{"groupId":"FG001","comment":"One subject withdrew consent before exposure to trial product due to personal reasons.","numSubjects":"253"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"250"},{"groupId":"FG001","numSubjects":"249"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set (FAS) included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\"","groups":[{"id":"BG000","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern."},{"id":"BG001","title":"IGlar + IAsp","description":"Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L)."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"252"},{"groupId":"BG001","value":"254"},{"groupId":"BG002","value":"506"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.6","spread":"9.0"},{"groupId":"BG001","value":"58.0","spread":"8.6"},{"groupId":"BG002","value":"58.3","spread":"8.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"137"},{"groupId":"BG002","value":"279"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"110"},{"groupId":"BG001","value":"117"},{"groupId":"BG002","value":"227"}]}]}]},{"title":"Glycosylated haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated haemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.21","spread":"0.76"},{"groupId":"BG001","value":"8.24","spread":"0.81"},{"groupId":"BG002","value":"8.22","spread":"0.78"}]}]}]},{"title":"Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"87.2","spread":"16.0"},{"groupId":"BG001","value":"88.2","spread":"17.2"},{"groupId":"BG002","value":"87.7","spread":"16.6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c (Glycosylated Haemoglobin)","description":"Change in HbA1c values after 26 weeks of treatment.","populationDescription":"The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". 8 subjects in IDegLira and 9 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of glycosylated haemoglobin","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern."},{"id":"OG001","title":"IGlar + IAsp","description":"Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"244"},{"groupId":"OG001","value":"245"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.48","spread":"0.05"},{"groupId":"OG001","value":"-1.46","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change from baseline in HbA1c was analysed using a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline HbA1c as covariate. Interactions between visit and all factors and the covariate were also included in the model.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority for IDegLira vs basal-bolus (IGlar + IAsp) was considered confirmed if the upper boundary of the two-sided 95% confidence interval was strictly below 0.30% or equivalent for non-inferiority using one-sided test for null hypothesis (H0): D ≥0.30% against alternative hypothesis (HA): D \\<0.30% was less than or equal to 2.5%, where D is the mean treatment difference (IDegLira minus basal-bolus).","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment contrast","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.16","ciUpperLimit":"0.12"}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.","description":"Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \\<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.","populationDescription":"The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation \"as treated\". One subject in IGlar + IAsp arm did not contribute to the analysis for this endpoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Number of episodes","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern."},{"id":"OG001","title":"IGlar + IAsp","description":"Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"253"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"975"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Hypoglycaemic episodes were analysed using a negative binomial regression. The model included treatment and region as fixed factors and logarithm of the time period in which a hypoglycaemic episode considered treatment emergent as offset. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Negative binomial regression model","paramType":"Treatment ratio","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.08","ciUpperLimit":"0.17","estimateComment":"Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment rate ratio was entirely below 1.0."}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight after 26 weeks of treatment.","populationDescription":"The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". 08 subjects in both IDegLira and IGlar + IAsp arm did not contribute to the analysis for this endpoint.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern."},{"id":"OG001","title":"IGlar + IAsp","description":"Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"244"},{"groupId":"OG001","value":"246"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.93","spread":"0.22"},{"groupId":"OG001","value":"2.64","spread":"0.22"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Body weight measurements were analysed using a linear mixed model with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline bodyweight as covariate. Interactions between visit and all factors and the covariate were also included in the model. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-3.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.19","ciUpperLimit":"-2.95","estimateComment":"Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment difference was below 0 or equal to zero."}]},{"type":"SECONDARY","title":"Responder for HbA1c Below 7.0%","description":"Number of subjects with HbA1c below 7% after 26 weeks of treatment.","populationDescription":"The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 26 weeks of treatment","groups":[{"id":"OG000","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern."},{"id":"OG001","title":"IGlar + IAsp","description":"Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"156"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"77"}]}]}]},{"type":"SECONDARY","title":"Responder for HbA1c Below or Equal to 6.5 %","description":"Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.","populationDescription":"The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 26 weeks of treatment","groups":[{"id":"OG000","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern."},{"id":"OG001","title":"IGlar + IAsp","description":"Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"104"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"129"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up).","description":"The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation \"as treated\".","eventGroups":[{"id":"EG000","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.","seriousNumAffected":12,"seriousNumAtRisk":252,"otherNumAffected":84,"otherNumAtRisk":252},{"id":"EG001","title":"IGlar + IAsp","description":"Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \\[72- 90 mg/dL\\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).","seriousNumAffected":10,"seriousNumAtRisk":253,"otherNumAffected":79,"otherNumAtRisk":253}],"seriousEvents":[{"term":"Anal fistula","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":252},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":253}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":252},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":253}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":252},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":253}]},{"term":"Atrial flutter","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":252},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":253}]},{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":252},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":253}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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