{"protocolSection":{"identificationModule":{"nctId":"NCT01029886","orgStudyIdInfo":{"id":"H8O-MC-GWDE"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes","officialTitle":"Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-01"},"primaryCompletionDateStruct":{"date":"2011-01","type":"ACTUAL"},"completionDateStruct":{"date":"2011-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-12-08","studyFirstSubmitQcDate":"2009-12-08","studyFirstPostDateStruct":{"date":"2009-12-10","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-02-14","resultsFirstSubmitQcDate":"2012-02-14","resultsFirstPostDateStruct":{"date":"2012-03-21","type":"ESTIMATED"},"dispFirstSubmitDate":"2011-06-17","dispFirstSubmitQcDate":"2011-06-17","dispFirstPostDateStruct":{"date":"2011-06-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-20","lastUpdatePostDateStruct":{"date":"2015-04-09","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["diabetes","exenatide once weekly","Byetta","liraglutide","Victoza","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":912,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide once weekly"]},{"label":"2","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: liraglutide"]}],"interventions":[{"type":"DRUG","name":"exenatide once weekly","description":"subcutaneous injection, 2mg, once weekly","armGroupLabels":["1"]},{"type":"DRUG","name":"liraglutide","description":"subcutaneous injection, forced titration to 1.8mg, once daily","armGroupLabels":["2"],"otherNames":["Victoza"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c From Baseline to Week 26","description":"Change in HbA1c from baseline to the treatment endpoint at Week 26.","timeFrame":"Baseline, Week 26"}],"secondaryOutcomes":[{"measure":"Percentage of Patients Achieving HbA1c <7.0% at Week 26","description":"Percentage of patients achieving HbA1c \\<7.0% at treatment endpoint at Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Fasting Serum Glucose From Baseline to Week 26","description":"Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Body Weight From Baseline to Week 26","description":"Change in body weight from baseline to the treatment endpoint at Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Total Cholesterol From Baseline to Week 26","description":"Change in total cholesterol from baseline to the treatment endpoint at Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26","description":"Change in HDL-C from baseline to the treatment endpoint at Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Ratio of Fasting Triglycerides at Week 26 to Baseline","description":"Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Systolic Blood Pressure (SBP) From Baseline to Week 26","description":"Change in SBP from baseline to the treatment endpoint at Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26","description":"Change in DBP from baseline to the treatment endpoint at Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Assessment of Event Rate of Treatment-emergent Hypoglycemic Events","description":"Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \\<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\\*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.","timeFrame":"Baseline to Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes\n* Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start 7.1% and 11.0%, inclusive\n* Have a body mass index (BMI) ≤45 kg/m\\^2\n* Have been treated with lifestyle modification (diet and exercise) and with one of the following single oral antidiabetic agents (OADs) or combinations of OADs administered at maximum tolerated dose:\n\n  * metformin\n  * SU\n  * metformin plus an SU\n  * metformin plus pioglitazone\n\nExclusion Criteria:\n\n* Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents\n* If taking metformin and have a contraindication to metformin use\n* Have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route\n* Have been treated with drugs that promote weight loss (e.g., Xenical® \\[orlistat\\], Meridia® \\[sibutramine\\], Acomplia® \\[rimonabant\\], Acutrim® \\[phenylpropanolamine\\], or similar over-the-counter medications) within 3 months of study start\n* Have taken any of the following excluded medications for more than 1 week within the 3 months prior to study start, or have taken any of the following excluded medications within 1 month prior to study start:\n\n  * Insulin\n  * Alpha-glucosidase inhibitors (e.g., Glyser® \\[miglitol\\] or Precose® \\[acarbose\\])\n  * Meglitinides (e.g., Prandin® \\[repaglinide\\] or Starlix® \\[nateglinide\\])\n  * Avandia® (rosiglitazone)\n  * Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ \\[sitagliptin\\], Galvus® \\[vildagliptin\\], Onglyza™ \\[saxagliptin\\])\n  * Symlin® (pramlintide acetate)\n* Have donated blood within 30 days prior to study start or have had a blood transfusion or severe blood loss within 3 months prior to study start\n* Have at any time, including a clinical trial, taken exenatide once weekly, exenatide twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog\n* Are currently enrolled in, or discontinued within the last 3 months or longer if required by local guidelines, from a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study\n* Have previously been screen-failed from this study for any reason\n* If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening, the subject can be included if they discontinued the medication (whether alone or as component of combined medication) according to a specific schedule.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 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Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660."},{"pmid":"23141817","type":"DERIVED","citation":"Buse JB, Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao A, Boardman MK, Fineman M, Porter L, Schernthaner G. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013 Jan 12;381(9861):117-24. doi: 10.1016/S0140-6736(12)61267-7. Epub 2012 Nov 7."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"FG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"461"},{"groupId":"FG001","numSubjects":"451"}]},{"type":"Intent to Treat (ITT)","achievements":[{"groupId":"FG000","numSubjects":"461"},{"groupId":"FG001","numSubjects":"450"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"400"},{"groupId":"FG001","numSubjects":"391"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"60"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"25"}]},{"type":"Lost to 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All observed data from all scheduled visits (including early termination visits) were included in the mixed-model repeated measures (MMRM) analysis. Data collected at the early termination visits were mapped into the following scheduled visits.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of total hemoglobin","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"390"},{"groupId":"OG001","value":"386"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.28","spread":"0.05"},{"groupId":"OG001","value":"-1.48","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A sample of 408 subjects in each treatment arm would provide approximately 90% power to detect a true difference between treatments of 0.25% in change in HbA1c from baseline with a 2 sided t-test at a significance level of 0.05, assuming a common standard deviation of 1.1%. MMRM model includes treatment, baseline HbA1c, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Superiority of exenatide once weekly with respect to change in HbA1c was concluded if the upper limit of the 2-sided 95% confidence interval (CI) for the treatment difference (exenatide once weekly minus liraglutide) was less than zero. Non-inferiority was concluded if the upper limit of the CI was \\<0.25%.","pValue":"0.002","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.08","ciUpperLimit":"0.33","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.07"}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving HbA1c <7.0% at Week 26","description":"Percentage of patients achieving HbA1c \\<7.0% at treatment endpoint at Week 26.","populationDescription":"ITT Population. Missing data at endpoint was imputed using last observation carried forward approach.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"450"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.7"},{"groupId":"OG001","value":"60.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Percentage of patients achieving HbA1c \\<7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel test, in which HbA1c stratum, country, and background OAD served as stratification factors.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.011","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change in Fasting Serum Glucose From Baseline to Week 26","description":"Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.","populationDescription":"ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"385"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.76","spread":"0.11"},{"groupId":"OG001","value":"-2.12","spread":"0.12"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"MMRM model includes treatment, baseline fasting serum glucose, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.021","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.05","ciUpperLimit":"0.66","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.15"}]},{"type":"SECONDARY","title":"Change in Body Weight From Baseline to Week 26","description":"Change in body weight from baseline to the treatment endpoint at Week 26.","populationDescription":"ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"398"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.68","spread":"0.18"},{"groupId":"OG001","value":"-3.57","spread":"0.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"MMRM model includes treatment, baseline body weight, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"0.90","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.39","ciUpperLimit":"1.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.26"}]},{"type":"SECONDARY","title":"Change in Total Cholesterol From Baseline to Week 26","description":"Change in total cholesterol from baseline to the treatment endpoint at Week 26.","populationDescription":"ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"402"},{"groupId":"OG001","value":"386"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.06","spread":"0.04"},{"groupId":"OG001","value":"-0.15","spread":"0.04"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"MMRM model includes treatment, baseline total cholesterol, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.079","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.01","ciUpperLimit":"0.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.05"}]},{"type":"SECONDARY","title":"Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26","description":"Change in HDL-C from baseline to the treatment endpoint at Week 26.","populationDescription":"ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"402"},{"groupId":"OG001","value":"386"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"0.01"},{"groupId":"OG001","value":"0.02","spread":"0.01"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"MMRM model includes treatment, baseline HDL-C, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.832","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"0.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.02","ciUpperLimit":"0.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.01"}]},{"type":"SECONDARY","title":"Ratio of Fasting Triglycerides at Week 26 to Baseline","description":"Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.","populationDescription":"ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"395"},{"groupId":"OG001","value":"385"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"0.02"},{"groupId":"OG001","value":"0.89","spread":"0.02"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Fasting triglycerides were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM model with treatment, baseline fasting triglycerides, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"1.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.04","ciUpperLimit":"1.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03"}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure (SBP) From Baseline to Week 26","description":"Change in SBP from baseline to the treatment endpoint at Week 26.","populationDescription":"ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"398"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.48","spread":"0.56"},{"groupId":"OG001","value":"-3.45","spread":"0.57"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"MMRM model includes treatment, baseline SBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.205","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"0.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.53","ciUpperLimit":"2.47","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.76"}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26","description":"Change in DBP from baseline to the treatment endpoint at Week 26.","populationDescription":"ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once weekly"},{"id":"OG001","title":"Liraglutide Once Daily","description":"Subcutaneous injection, forced titration to 1.8mg, once daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"398"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.49","spread":"0.37"},{"groupId":"OG001","value":"-0.51","spread":"0.37"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.981","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.96","ciUpperLimit":"0.98","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.50"}]},{"type":"SECONDARY","title":"Assessment of Event Rate of Treatment-emergent Hypoglycemic Events","description":"Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \\<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\\*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.","populationDescription":"ITT Population.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"events per subject-year","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly With SU Use at Screening","description":"Subcutaneous injection, 2mg, once weekly and with SU use at screening"},{"id":"OG001","title":"Liraglutide Once Daily With SU Use at Screening","description":"Subcutaneous injection, forced titration to 1.8mg, once daily and with SU use at screening"},{"id":"OG002","title":"Exenatide Once Weekly Without SU Use at Screening","description":"Subcutaneous injection, 2mg, once weekly and without SU use at screening"},{"id":"OG003","title":"Liraglutide Once Daily Without SU Use at Screening","description":"Subcutaneous injection, forced titration to 1.8mg, once daily and without SU use at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"296"},{"groupId":"OG002","value":"167"},{"groupId":"OG003","value":"154"}]}],"classes":[{"title":"Major Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.000"},{"groupId":"OG001","value":"0.00","spread":"0.000"},{"groupId":"OG002","value":"0.00","spread":"0.000"},{"groupId":"OG003","value":"0.00","spread":"0.000"}]}]},{"title":"Minor Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0.76","spread":"0.143"},{"groupId":"OG001","value":"0.55","spread":"0.126"},{"groupId":"OG002","value":"0.67","spread":"0.417"},{"groupId":"OG003","value":"0.05","spread":"0.026"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2mg, once 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14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":461},{"groupId":"EG001","numAffected":0,"numAtRisk":450}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":461},{"groupId":"EG001","numAffected":0,"numAtRisk":450}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":461},{"groupId":"EG001","numAffected":1,"numAtRisk":450}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":461},{"groupId":"EG001","numAffected":0,"numAtRisk":450}]},{"term":"Gastrointestinal 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14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":461},{"groupId":"EG001","numAffected":1,"numAtRisk":450}]},{"term":"Brain stem infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":461},{"groupId":"EG001","numAffected":1,"numAtRisk":450}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":461},{"groupId":"EG001","numAffected":1,"numAtRisk":450}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":461},{"groupId":"EG001","numAffected":1,"numAtRisk":450}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":461},{"groupId":"EG001","numAffected":1,"numAtRisk":450}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":461},{"groupId":"EG001","numAffected":1,"numAtRisk":450}]}],"otherEvents":[{"term":"Injection site nodule","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":461},{"groupId":"EG001","numAffected":5,"numAtRisk":450}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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