{"protocolSection":{"identificationModule":{"nctId":"NCT00614120","orgStudyIdInfo":{"id":"NN2211-1796"},"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes","officialTitle":"Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2017-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-01"},"primaryCompletionDateStruct":{"date":"2009-02","type":"ACTUAL"},"completionDateStruct":{"date":"2009-02","type":"ACTUAL"},"studyFirstSubmitDate":"2008-01-15","studyFirstSubmitQcDate":"2008-02-12","studyFirstPostDateStruct":{"date":"2008-02-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-02-23","resultsFirstSubmitQcDate":"2010-02-23","resultsFirstPostDateStruct":{"date":"2010-03-12","type":"ESTIMATED"},"dispFirstSubmitDate":"2009-11-09","dispFirstSubmitQcDate":"2009-11-09","dispFirstPostDateStruct":{"date":"2009-11-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-01-25","lastUpdatePostDateStruct":{"date":"2017-03-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in Asia. 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Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial(*). Diabetes Obes Metab. 2011 Jan;13(1):81-8. doi: 10.1111/j.1463-1326.2010.01323.x."},{"pmid":"23010561","type":"RESULT","citation":"Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23."},{"pmid":"25504028","type":"RESULT","citation":"Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12."},{"pmid":"25684604","type":"RESULT","citation":"Ingwersen SH, Petri KC, Tandon N, Yoon KH, Chen L, Vora J, Yang W. Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea. Diabetes Res Clin Pract. 2015 Apr;108(1):113-9. doi: 10.1016/j.diabres.2015.01.001. Epub 2015 Jan 19."},{"pmid":"21450987","type":"DERIVED","citation":"Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A metformin run-in period of 3 weeks followed by a metformin maintenance period of 3 weeks before randomisation with dose levels increased to 2000 mg/day. Subjects already on metformin therapy at enrolment could go through a modified titration period or advance directly to the metformin maintenance period at the discretion of the investigator.","recruitmentDetails":"A total of 51 centres in three countries: China (17), India (24) and South Korea (10)","groups":[{"id":"FG000","title":"Lira 0.6 + Met","description":"Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"FG001","title":"Lira 1.2 + Met","description":"Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"FG002","title":"Lira 1.8 + Met","description":"Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"FG003","title":"Glim + Met","description":"Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo"}],"periods":[{"title":"Overall 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Met","description":"Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"222"},{"groupId":"OG002","value":"221"},{"groupId":"OG003","value":"230"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"1.04"},{"groupId":"OG001","value":"-1.3","spread":"1.09"},{"groupId":"OG002","value":"-1.4","spread":"1.23"},{"groupId":"OG003","value":"-1.3","spread":"0.98"}]}]}],"analyses":[{"groupIds":["OG002","OG003"],"groupDescription":"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.\n\nAssuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%.","pValue":"<0.0001","pValueComment":"Non-inferiority; \\<.0001. In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.","statisticalMethod":"ANCOVA","statisticalComment":"ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.","paramType":"Estimated treatment difference, LS Mean","paramValue":"-0.06","ciPctValue":"95","ciLowerLimit":"-0.23","ciUpperLimit":"0.11","estimateComment":"The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level."},{"groupIds":["OG001","OG003"],"groupDescription":"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.\n\nAssuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%.","pValue":"<.0001","pValueComment":"In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.","statisticalMethod":"ANCOVA","statisticalComment":"ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.","paramType":"Estimated treatment difference, LS Mean","paramValue":"0.03","ciPctValue":"95","ciLowerLimit":"-0.14","ciUpperLimit":"0.20","estimateComment":"The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level."},{"groupIds":["OG000","OG003"],"groupDescription":"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.\n\nAssuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%.","pValue":"0.0421","pValueComment":"In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.","statisticalMethod":"ANCOVA","statisticalComment":"ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.","paramType":"Estimated treatment difference, LS Mean","paramValue":"0.25","ciPctValue":"95","ciLowerLimit":"0.08","ciUpperLimit":"0.42","estimateComment":"The p-values correspond to one-sided hypotheses of either superiority or non-inferiority."}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight from baseline (week 0) to 16 weeks (end of treatment)","populationDescription":"The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"week 0, week 16","groups":[{"id":"OG000","title":"Lira 0.6 + Met","description":"Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG001","title":"Lira 1.2 + Met","description":"Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG002","title":"Lira 1.8 + Met","description":"Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG003","title":"Glim + Met","description":"Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"225"},{"groupId":"OG002","value":"224"},{"groupId":"OG003","value":"231"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"2.2"},{"groupId":"OG001","value":"-2.3","spread":"2.4"},{"groupId":"OG002","value":"-2.4","spread":"2.6"},{"groupId":"OG003","value":"0.1","spread":"2.2"}]}]}]},{"type":"SECONDARY","title":"Change in Self-measured Fasting Plasma Glucose","description":"Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.","populationDescription":"The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"week 0, week 16","groups":[{"id":"OG000","title":"Lira 0.6 + Met","description":"Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG001","title":"Lira 1.2 + Met","description":"Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG002","title":"Lira 1.8 + Met","description":"Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG003","title":"Glim + Met","description":"Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"222"},{"groupId":"OG003","value":"229"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.83","spread":"2.66"},{"groupId":"OG001","value":"-1.96","spread":"2.35"},{"groupId":"OG002","value":"-2.28","spread":"2.94"},{"groupId":"OG003","value":"-2.13","spread":"2.25"}]}]}]},{"type":"SECONDARY","title":"7-point Self-measured Plasma Glucose Profiles","description":"Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).","populationDescription":"The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dl","timeFrame":"week 0, 8, 12 and 16","groups":[{"id":"OG000","title":"Lira 0.6 + Met","description":"Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG001","title":"Lira 1.2 + Met","description":"Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG002","title":"Lira 1.8 + Met","description":"Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG003","title":"Glim + Met","description":"Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"233"},{"groupId":"OG002","value":"233"},{"groupId":"OG003","value":"231"}]}],"classes":[{"title":"Week 0 - Before breakfast","categories":[{"measurements":[{"groupId":"OG000","value":"168.2","spread":"43.5"},{"groupId":"OG001","value":"167.5","spread":"42.5"},{"groupId":"OG002","value":"168.8","spread":"40.4"},{"groupId":"OG003","value":"163.8","spread":"41.2"}]}]},{"title":"Week 0 - 90 minutes after breakfast","categories":[{"measurements":[{"groupId":"OG000","value":"245.9","spread":"71.6"},{"groupId":"OG001","value":"248.0","spread":"70.0"},{"groupId":"OG002","value":"245.4","spread":"63.8"},{"groupId":"OG003","value":"238.5","spread":"62.4"}]}]},{"title":"Week 0 - Before lunch","categories":[{"measurements":[{"groupId":"OG000","value":"178.5","spread":"62.7"},{"groupId":"OG001","value":"180.5","spread":"63.5"},{"groupId":"OG002","value":"176.9","spread":"56.8"},{"groupId":"OG003","value":"175.8","spread":"61.0"}]}]},{"title":"Week 0 - 90 minutes after lunch","categories":[{"measurements":[{"groupId":"OG000","value":"234.2","spread":"68.7"},{"groupId":"OG001","value":"232.3","spread":"67.0"},{"groupId":"OG002","value":"234.4","spread":"64.2"},{"groupId":"OG003","value":"227.6","spread":"67.0"}]}]},{"title":"Week 0 - Before dinner","categories":[{"measurements":[{"groupId":"OG000","value":"194.8","spread":"63.0"},{"groupId":"OG001","value":"184.8","spread":"65.0"},{"groupId":"OG002","value":"190.9","spread":"61.7"},{"groupId":"OG003","value":"180.2","spread":"59.2"}]}]},{"title":"Week 0 - 90 minutes after dinner","categories":[{"measurements":[{"groupId":"OG000","value":"239.6","spread":"65.3"},{"groupId":"OG001","value":"239.6","spread":"71.3"},{"groupId":"OG002","value":"244.0","spread":"69.8"},{"groupId":"OG003","value":"231.6","spread":"60.3"}]}]},{"title":"Week 0 - Bedtime","categories":[{"measurements":[{"groupId":"OG000","value":"205.7","spread":"69.6"},{"groupId":"OG001","value":"208.1","spread":"67.5"},{"groupId":"OG002","value":"219.3","spread":"71.7"},{"groupId":"OG003","value":"202.7","spread":"66.4"}]}]},{"title":"Week 8 - Before breakfast","categories":[{"measurements":[{"groupId":"OG000","value":"137.0","spread":"31.2"},{"groupId":"OG001","value":"130.4","spread":"28.0"},{"groupId":"OG002","value":"133.7","spread":"28.4"},{"groupId":"OG003","value":"130.1","spread":"31.8"}]}]},{"title":"Week 8 - 90 minutes after breakfast","categories":[{"measurements":[{"groupId":"OG000","value":"198.5","spread":"55.8"},{"groupId":"OG001","value":"190.1","spread":"50.8"},{"groupId":"OG002","value":"178.5","spread":"48.2"},{"groupId":"OG003","value":"201.2","spread":"54.4"}]}]},{"title":"Week 8 - Before lunch","categories":[{"measurements":[{"groupId":"OG000","value":"144.8","spread":"45.2"},{"groupId":"OG001","value":"136.5","spread":"41.8"},{"groupId":"OG002","value":"138.0","spread":"37.8"},{"groupId":"OG003","value":"132.6","spread":"46.1"}]}]},{"title":"Week 8 - 90 minutes after lunch","categories":[{"measurements":[{"groupId":"OG000","value":"187.2","spread":"48.7"},{"groupId":"OG001","value":"176.9","spread":"49.5"},{"groupId":"OG002","value":"177.9","spread":"48.4"},{"groupId":"OG003","value":"184.3","spread":"54.2"}]}]},{"title":"Week 8 - Before dinner","categories":[{"measurements":[{"groupId":"OG000","value":"159.1","spread":"47.5"},{"groupId":"OG001","value":"147.8","spread":"40.1"},{"groupId":"OG002","value":"144.2","spread":"40.6"},{"groupId":"OG003","value":"143.3","spread":"47.8"}]}]},{"title":"Week 8 - 90 minutes after dinner","categories":[{"measurements":[{"groupId":"OG000","value":"193.7","spread":"53.2"},{"groupId":"OG001","value":"187.1","spread":"49.3"},{"groupId":"OG002","value":"183.3","spread":"53.9"},{"groupId":"OG003","value":"190.2","spread":"51.7"}]}]},{"title":"Week 8 - Bedtime","categories":[{"measurements":[{"groupId":"OG000","value":"169.1","spread":"51.5"},{"groupId":"OG001","value":"161.6","spread":"47.1"},{"groupId":"OG002","value":"155.8","spread":"45.6"},{"groupId":"OG003","value":"163.6","spread":"50.5"}]}]},{"title":"Week 12 - Before breakfast","categories":[{"measurements":[{"groupId":"OG000","value":"137.8","spread":"33.6"},{"groupId":"OG001","value":"130.2","spread":"25.0"},{"groupId":"OG002","value":"130.2","spread":"26.8"},{"groupId":"OG003","value":"128.5","spread":"29.7"}]}]},{"title":"Week 12 - 90 minutes after breakfast","categories":[{"measurements":[{"groupId":"OG000","value":"197.5","spread":"54.2"},{"groupId":"OG001","value":"185.7","spread":"49.4"},{"groupId":"OG002","value":"178.6","spread":"51.6"},{"groupId":"OG003","value":"200.8","spread":"57.9"}]}]},{"title":"Week 12 - Before lunch","categories":[{"measurements":[{"groupId":"OG000","value":"141.8","spread":"48.3"},{"groupId":"OG001","value":"135.6","spread":"40.3"},{"groupId":"OG002","value":"134.1","spread":"40.3"},{"groupId":"OG003","value":"129.3","spread":"47.7"}]}]},{"title":"Week 12 - 90 minutes after lunch","categories":[{"measurements":[{"groupId":"OG000","value":"183.7","spread":"50.0"},{"groupId":"OG001","value":"174.7","spread":"46.2"},{"groupId":"OG002","value":"173.7","spread":"53.1"},{"groupId":"OG003","value":"185.3","spread":"52.0"}]}]},{"title":"Week 12 - Before dinner","categories":[{"measurements":[{"groupId":"OG000","value":"156.4","spread":"44.8"},{"groupId":"OG001","value":"143.4","spread":"36.1"},{"groupId":"OG002","value":"144.5","spread":"43.0"},{"groupId":"OG003","value":"144.2","spread":"49.2"}]}]},{"title":"Week 12 - 90 minutes after dinner","categories":[{"measurements":[{"groupId":"OG000","value":"197.2","spread":"51.8"},{"groupId":"OG001","value":"185.7","spread":"47.1"},{"groupId":"OG002","value":"183.5","spread":"51.7"},{"groupId":"OG003","value":"188.5","spread":"50.1"}]}]},{"title":"Week 12 - Bedtime","categories":[{"measurements":[{"groupId":"OG000","value":"168.2","spread":"52.1"},{"groupId":"OG001","value":"158.9","spread":"45.3"},{"groupId":"OG002","value":"158.9","spread":"47.0"},{"groupId":"OG003","value":"159.9","spread":"47.6"}]}]},{"title":"Week 16 - Before breakfast","categories":[{"measurements":[{"groupId":"OG000","value":"137.3","spread":"31.2"},{"groupId":"OG001","value":"132.9","spread":"26.4"},{"groupId":"OG002","value":"128.6","spread":"26.1"},{"groupId":"OG003","value":"131.0","spread":"35.3"}]}]},{"title":"Week 16 - 90 minutes after breakfast","categories":[{"measurements":[{"groupId":"OG000","value":"195.6","spread":"57.1"},{"groupId":"OG001","value":"188.7","spread":"51.6"},{"groupId":"OG002","value":"177.6","spread":"51.6"},{"groupId":"OG003","value":"195.1","spread":"57.4"}]}]},{"title":"Week 16 - Before lunch","categories":[{"measurements":[{"groupId":"OG000","value":"140.5","spread":"41.3"},{"groupId":"OG001","value":"137.0","spread":"40.3"},{"groupId":"OG002","value":"137.8","spread":"40.8"},{"groupId":"OG003","value":"128.8","spread":"45.4"}]}]},{"title":"Week 16 - 90 minutes after lunch","categories":[{"measurements":[{"groupId":"OG000","value":"185.8","spread":"44.4"},{"groupId":"OG001","value":"181.4","spread":"46.7"},{"groupId":"OG002","value":"173.2","spread":"50.7"},{"groupId":"OG003","value":"182.2","spread":"51.8"}]}]},{"title":"Week 16 - Before dinner","categories":[{"measurements":[{"groupId":"OG000","value":"151.5","spread":"38.5"},{"groupId":"OG001","value":"148.4","spread":"39.8"},{"groupId":"OG002","value":"140.9","spread":"38.8"},{"groupId":"OG003","value":"144.9","spread":"45.3"}]}]},{"title":"Week 16 - 90 minutes after dinner","categories":[{"measurements":[{"groupId":"OG000","value":"195.0","spread":"52.2"},{"groupId":"OG001","value":"183.3","spread":"46.2"},{"groupId":"OG002","value":"173.2","spread":"48.3"},{"groupId":"OG003","value":"192.6","spread":"53.8"}]}]},{"title":"Week 16 - Bedtime","categories":[{"measurements":[{"groupId":"OG000","value":"166.4","spread":"50.6"},{"groupId":"OG001","value":"159.8","spread":"44.7"},{"groupId":"OG002","value":"151.6","spread":"40.3"},{"groupId":"OG003","value":"157.7","spread":"47.6"}]}]}]},{"type":"SECONDARY","title":"Change in Beta-cell Function","description":"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).","populationDescription":"The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage point (%point)","timeFrame":"week 0, week 16","groups":[{"id":"OG000","title":"Lira 0.6 + Met","description":"Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG001","title":"Lira 1.2 + Met","description":"Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG002","title":"Lira 1.8 + Met","description":"Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG003","title":"Glim + Met","description":"Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"216"},{"groupId":"OG001","value":"216"},{"groupId":"OG002","value":"213"},{"groupId":"OG003","value":"222"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.3","spread":"94.6"},{"groupId":"OG001","value":"17.8","spread":"30.4"},{"groupId":"OG002","value":"21.7","spread":"78.5"},{"groupId":"OG003","value":"21.8","spread":"43.1"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Lipid Profile","description":"Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:\n\n* Total Cholesterol (TC)\n* Low-density Lipoprotein-cholesterol (LDL-C)\n* Very Low-density Lipoprotein-cholesterol (VLDL-C)\n* High-density Lipoprotein-cholesterol (HDL-C)\n* Triglyceride (TG)\n* Free Fatty Acid (FFA)","populationDescription":"The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"week 0, week 16","groups":[{"id":"OG000","title":"Lira 0.6 + Met","description":"Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG001","title":"Lira 1.2 + Met","description":"Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG002","title":"Lira 1.8 + Met","description":"Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG003","title":"Glim + Met","description":"Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"233"},{"groupId":"OG002","value":"233"},{"groupId":"OG003","value":"231"}]}],"classes":[{"title":"Change in TC (Absolute), N=221, 216, 216, 228","categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.74"},{"groupId":"OG001","value":"-0.01","spread":"0.77"},{"groupId":"OG002","value":"-0.03","spread":"0.73"},{"groupId":"OG003","value":"0.02","spread":"0.73"}]}]},{"title":"Change in LDL-C (Absolute), N=221, 216, 216, 228","categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.61"},{"groupId":"OG001","value":"-0.03","spread":"0.64"},{"groupId":"OG002","value":"0.00","spread":"0.58"},{"groupId":"OG003","value":"0.04","spread":"0.55"}]}]},{"title":"Change in VLDL-C (Absolute), N=213, 210, 207, 220","categories":[{"measurements":[{"groupId":"OG000","value":"0.03","spread":"0.35"},{"groupId":"OG001","value":"0.05","spread":"0.40"},{"groupId":"OG002","value":"0.01","spread":"0.35"},{"groupId":"OG003","value":"0.05","spread":"0.42"}]}]},{"title":"Change in HDL-C (Absolute), N=217, 212, 212, 220","categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","spread":"0.19"},{"groupId":"OG001","value":"-0.05","spread":"0.34"},{"groupId":"OG002","value":"-0.05","spread":"0.15"},{"groupId":"OG003","value":"-0.01","spread":"0.34"}]}]},{"title":"Change in TG (Absolute), N=220, 212, 213, 226","categories":[{"measurements":[{"groupId":"OG000","value":"-0.08","spread":"0.96"},{"groupId":"OG001","value":"-0.06","spread":"1.13"},{"groupId":"OG002","value":"-0.22","spread":"1.57"},{"groupId":"OG003","value":"-0.07","spread":"1.26"}]}]},{"title":"Change in FFA (Absolute), N=218, 214, 216, 227","categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"0.28"},{"groupId":"OG001","value":"-0.04","spread":"0.28"},{"groupId":"OG002","value":"-0.10","spread":"0.28"},{"groupId":"OG003","value":"-0.02","spread":"0.28"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Lipid Profile, APO-B","description":"Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).","populationDescription":"The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Standard Deviation","unitOfMeasure":"g/L","timeFrame":"week 0, week 16","groups":[{"id":"OG000","title":"Lira 0.6 + Met","description":"Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG001","title":"Lira 1.2 + Met","description":"Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG002","title":"Lira 1.8 + Met","description":"Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo"},{"id":"OG003","title":"Glim + Met","description":"Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"216"},{"groupId":"OG002","value":"216"},{"groupId":"OG003","value":"228"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"0.17"},{"groupId":"OG001","value":"0.00","spread":"0.18"},{"groupId":"OG002","value":"-0.00","spread":"0.16"},{"groupId":"OG003","value":"0.01","spread":"0.17"}]}]}]},{"type":"SECONDARY","title":"Hypoglycaemic Episodes","description":"Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). 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