{"protocolSection":{"identificationModule":{"nctId":"NCT00395746","orgStudyIdInfo":{"id":"NN2211-1701"},"secondaryIdInfos":[{"id":"JapicCTI-060324","type":"REGISTRY","domain":"japic"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes","officialTitle":"Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2017-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-10"},"primaryCompletionDateStruct":{"date":"2007-10","type":"ACTUAL"},"completionDateStruct":{"date":"2008-05","type":"ACTUAL"},"studyFirstSubmitDate":"2006-11-02","studyFirstSubmitQcDate":"2006-11-02","studyFirstPostDateStruct":{"date":"2006-11-03","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-02-23","resultsFirstSubmitQcDate":"2010-02-23","resultsFirstPostDateStruct":{"date":"2010-03-12","type":"ESTIMATED"},"dispFirstSubmitDate":"2009-10-26","dispFirstSubmitQcDate":"2009-10-26","dispFirstPostDateStruct":{"date":"2009-10-28","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 Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":264,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"0.6 mg + SU","type":"EXPERIMENTAL","description":"Liraglutide 0.6 mg + sulphonylurea","interventionNames":["Drug: sulfonylurea","Drug: liraglutide"]},{"label":"0.9 mg + SU","type":"EXPERIMENTAL","description":"Liraglutide 0.9 mg + sulphonylurea","interventionNames":["Drug: sulfonylurea","Drug: liraglutide"]},{"label":"SU Mono - 1","type":"PLACEBO_COMPARATOR","description":"Liraglutide placebo 0.6 mg + sulphonylurea","interventionNames":["Drug: sulfonylurea"]},{"label":"SU Mono - 2","type":"PLACEBO_COMPARATOR","description":"Liraglutide placebo 0.9 mg + sulphonylurea","interventionNames":["Drug: sulfonylurea"]}],"interventions":[{"type":"DRUG","name":"sulfonylurea","description":"SU agent","armGroupLabels":["0.6 mg + SU","0.9 mg + SU","SU Mono - 1","SU Mono - 2"]},{"type":"DRUG","name":"liraglutide","description":"Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.","armGroupLabels":["0.6 mg + SU"]},{"type":"DRUG","name":"liraglutide","description":"Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.","armGroupLabels":["0.9 mg + SU"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment","timeFrame":"after 24 weeks of treatment"}],"secondaryOutcomes":[{"measure":"Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment","timeFrame":"after 52 weeks of treatment"},{"measure":"Fasting Plasma Glucose After 24 Weeks of Treatment","timeFrame":"after 24 weeks of treatment"},{"measure":"Fasting Plasma Glucose After 52 Weeks of Treatment","timeFrame":"after 52 weeks of treatment"},{"measure":"Postprandial Glucose AUC After 24 Weeks of Treatment","description":"Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment","timeFrame":"after 24 weeks of treatment"},{"measure":"Postprandial Glucose AUC After 52 Weeks of Treatment","description":"Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment","timeFrame":"after 52 weeks of treatment"},{"measure":"Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment","description":"Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.","timeFrame":"after 24 weeks of treatment"},{"measure":"Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment","description":"7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.","timeFrame":"after 52 weeks of treatment"},{"measure":"Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment","description":"Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.","timeFrame":"after 24 weeks of treatment"},{"measure":"Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment","description":"Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.","timeFrame":"after 52 weeks of treatment"},{"measure":"Body Weight After 24 Weeks of Treatment","timeFrame":"after 24 weeks of treatment"},{"measure":"Body Weight After 52 Weeks of Treatment","timeFrame":"after 52 weeks of treatment"},{"measure":"Hypoglycaemic Episodes","description":"Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"over 52 weeks of treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes\n* Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks\n* HbA1c greater than or equal to 7.0% and less than 10.0%\n* BMI less than 35 kg/m2\n\nExclusion Criteria:\n\n* Treatment with insulin within the last 12 weeks\n* Treatment with any drug that could interfere with the glucose level\n* Any serious medical condition\n* Females who are pregnant, have intention of becoming pregnant or are breastfeeding","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"1000005","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}}]},"referencesModule":{"references":[{"pmid":"24843595","type":"RESULT","citation":"Seino Y, Rasmussen MF, Clauson P, Kaku K. The once-daily human glucagon-like peptide-1 analog, liraglutide, improves beta-cell function in Japanese patients with type 2 diabetes. J Diabetes Investig. 2012 Aug 20;3(4):388-95. doi: 10.1111/j.2040-1124.2012.00193.x."},{"pmid":"20380655","type":"RESULT","citation":"Kaku K, Rasmussen MF, Clauson P, Seino Y. Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Apr;12(4):341-7. doi: 10.1111/j.1463-1326.2009.01194.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":"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."},{"pmid":"21209033","type":"DERIVED","citation":"Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects included were patients with type 2 diabetes treated with diet therapy and one sulphonylurea (SU) agent (glibenclamide, gliclazide or glimepiride). Subjects continued their current SU therapy with, as a rule, no change in the dose and dosage in the study. A total of 267 subjects were randomised, 3 subjects were not exposed to study drug.","recruitmentDetails":"49 sites in Japan","groups":[{"id":"FG000","title":"0.6 mg + SU","description":"Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"FG001","title":"0.9 mg + SU","description":"Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"FG002","title":"SU Mono","description":"Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Exposed to study drug","numSubjects":"88"},{"groupId":"FG001","comment":"Exposed to study drug","numSubjects":"88"},{"groupId":"FG002","comment":"Exposed to study drug","numSubjects":"88"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Completed 52 weeks treatment","numSubjects":"78"},{"groupId":"FG001","comment":"Completed 52 weeks treatment","numSubjects":"84"},{"groupId":"FG002","comment":"Completed 52 weeks treatment","numSubjects":"66"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"22"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"17"}]},{"type":"Hypoglycaemia","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Subject decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal of consent","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Difficultulty in use of device","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Unable to visit site on schedule","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"0.6 mg + SU","description":"Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"BG001","title":"0.9 mg + SU","description":"Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"BG002","title":"SU Mono","description":"Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"88"},{"groupId":"BG003","value":"264"}]}],"measures":[{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"20-29","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]},{"title":"30-39","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"6"}]}]},{"title":"40-49","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"40"}]}]},{"title":"50-59","categories":[{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"79"}]}]},{"title":"60-69","categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"92"}]}]},{"title":"70-","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"46"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59.1","spread":"10.3"},{"groupId":"BG001","value":"61.3","spread":"11.0"},{"groupId":"BG002","value":"58.6","spread":"9.7"},{"groupId":"BG003","value":"59.7","spread":"10.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"31"},{"groupId":"BG003","value":"95"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"57"},{"groupId":"BG003","value":"169"}]}]}]},{"title":"BMI","description":"Body Mass Index","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"25.25","spread":"3.58"},{"groupId":"BG001","value":"24.40","spread":"3.37"},{"groupId":"BG002","value":"24.94","spread":"3.96"},{"groupId":"BG003","value":"24.86","spread":"3.65"}]}]}]},{"title":"Body weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"66.19","spread":"12.03"},{"groupId":"BG001","value":"64.53","spread":"11.95"},{"groupId":"BG002","value":"66.79","spread":"13.66"},{"groupId":"BG003","value":"65.84","spread":"12.56"}]}]}]},{"title":"Duration of diabetes","description":"Number of years since diagnosis of diabetes","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9.33","spread":"5.77"},{"groupId":"BG001","value":"11.61","spread":"7.68"},{"groupId":"BG002","value":"10.06","spread":"7.28"},{"groupId":"BG003","value":"10.33","spread":"7.00"}]}]}]},{"title":"HbA1c","description":"Glycosylated Haemoglobin","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of total haemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.48","spread":"0.73"},{"groupId":"BG001","value":"8.26","spread":"0.71"},{"groupId":"BG002","value":"8.44","spread":"0.83"},{"groupId":"BG003","value":"8.39","spread":"0.76"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment","populationDescription":"Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of total haemoglobin","timeFrame":"after 24 weeks of treatment","groups":[{"id":"OG000","title":"0.6 mg + SU","description":"Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"OG001","title":"0.9 mg + SU","description":"Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"OG002","title":"SU Mono","description":"Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"87"},{"groupId":"OG002","value":"88"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.02","spread":"0.10"},{"groupId":"OG001","value":"6.75","spread":"0.11"},{"groupId":"OG002","value":"8.02","spread":"0.10"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:\n\nH10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"A significance level of a two-sided 5% was used for statistical hypothesis testing.","statisticalMethod":"ANOVA","paramType":"Least Squares Mean","paramValue":"-1.27","ciPctValue":"95","ciLowerLimit":"-1.51","ciUpperLimit":"1.02"},{"groupIds":["OG000","OG002"],"groupDescription":"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:\n\nH10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANOVA","statisticalComment":"A significance level of a two-sided 5% was used for statistical hypothesis testing.","paramType":"Least Squares Mean","paramValue":"-1.00","ciPctValue":"95","ciLowerLimit":"-1.24","ciUpperLimit":"-0.75"}]},{"type":"SECONDARY","title":"Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment","populationDescription":"Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of total haemoglobin","timeFrame":"after 52 weeks of treatment","groups":[{"id":"OG000","title":"0.6 mg + SU","description":"Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"OG001","title":"0.9 mg + SU","description":"Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"OG002","title":"SU Mono","description":"Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"87"},{"groupId":"OG002","value":"88"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.42","spread":"0.12"},{"groupId":"OG001","value":"7.06","spread":"0.13"},{"groupId":"OG002","value":"8.39","spread":"0.12"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANOVA","paramType":"Least Squares Mean","paramValue":"-1.33","ciPctValue":"95","ciLowerLimit":"-1.62","ciUpperLimit":"-1.04"},{"groupIds":["OG000","OG002"],"groupDescription":"95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANOVA","paramType":"Least Squares Mean","paramValue":"-0.96","ciPctValue":"95","ciLowerLimit":"-1.25","ciUpperLimit":"-0.67"}]},{"type":"SECONDARY","title":"Fasting Plasma Glucose After 24 Weeks of Treatment","populationDescription":"Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"after 24 weeks of treatment","groups":[{"id":"OG000","title":"0.6 mg + SU","description":"Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"OG001","title":"0.9 mg + SU","description":"Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"},{"id":"OG002","title":"SU Mono","description":"Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"87"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"132.2","spread":"3.5"},{"groupId":"OG001","value":"126.2","spread":"3.5"},{"groupId":"OG002","value":"158.8","spread":"3.5"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.","statisticalMethod":"ANOVA","paramType":"Least Squares Mean","paramValue":"-32.4","ciPctValue":"95","ciLowerLimit":"-40.5","ciUpperLimit":"-24.2"},{"groupIds":["OG000","OG002"],"groupDescription":"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. 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