{"protocolSection":{"identificationModule":{"nctId":"NCT00935532","orgStudyIdInfo":{"id":"H8O-JE-GWBX"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus","officialTitle":"Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)"},"statusModule":{"statusVerifiedDate":"2015-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-07"},"primaryCompletionDateStruct":{"date":"2010-09","type":"ACTUAL"},"completionDateStruct":{"date":"2011-07","type":"ACTUAL"},"studyFirstSubmitDate":"2009-07-08","studyFirstSubmitQcDate":"2009-07-08","studyFirstPostDateStruct":{"date":"2009-07-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-02-14","resultsFirstSubmitQcDate":"2012-09-24","resultsFirstPostDateStruct":{"date":"2012-10-24","type":"ESTIMATED"},"dispFirstSubmitDate":"2011-06-17","dispFirstSubmitQcDate":"2011-06-17","dispFirstPostDateStruct":{"date":"2011-06-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-05-21","lastUpdatePostDateStruct":{"date":"2015-06-15","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":427,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"exenatide once weekly","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide once weekly"]},{"label":"insulin glargine","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: insulin glargine"]}],"interventions":[{"type":"DRUG","name":"exenatide once weekly","description":"subcutaneous injection, 2.0mg, once a week;","armGroupLabels":["exenatide once weekly"]},{"type":"DRUG","name":"insulin glargine","description":"subcutaneous injection, titrated to achieve fasting serum glucose target, once a day","armGroupLabels":["insulin glargine"],"otherNames":["insulin glargine-Lantus"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c From Baseline to Endpoint (Week 26)","description":"Change in HbA1c from baseline to endpoint (Week 26).","timeFrame":"Baseline, Week 26"}],"secondaryOutcomes":[{"measure":"Percentage of Subjects Achieving HbA1c<=7%","description":"Percentage of subjects achieving HbA1c \\<=7.0% (for subjects with HbA1c \\>7% at baseline)","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Subjects Achieving HbA1c<=6.5%","description":"Percentage of subjects achieving HbA1c \\<=6.5% (for subjects with HbA1c \\>6.5% at baseline)","timeFrame":"Baseline, Week 26"},{"measure":"Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)","description":"Change in FSG (centralized measurement) from baseline to endpoint (Week 26)","timeFrame":"Baseline, Week 26"},{"measure":"Change in Body Weight From Baseline to Endpoint (Week 26)","description":"Change in Body Weight from baseline to endpoint (Week 26)","timeFrame":"Baseline, Week 26"},{"measure":"Change in Total Cholesterol From Baseline to Endpoint (Week 26)","description":"Change in Total Cholesterol from baseline to endpoint (Week 26)","timeFrame":"Baseline, Week 26"},{"measure":"Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)","description":"Change in HDL-C from baseline to endpoint (Week 26)","timeFrame":"Baseline, Week 26"},{"measure":"Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline","description":"Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Blood Pressure From Baseline to Endpoint (Week 26)","description":"Change in Blood Pressure from baseline to endpoint (Week 26)","timeFrame":"Baseline, Week 26"},{"measure":"Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events","description":"Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.","timeFrame":"Baseline to Week 26"},{"measure":"Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events","description":"Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.","timeFrame":"Baseline to Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* present with type 2 diabetes mellitus\n* HbA1c between 7.1% and 11.0% inclusive\n* body mass index (BMI) of \\>18kg/m2 and \\<35kg/m2, inclusive\n* treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start\n\nExclusion Criteria:\n\n* Have received chronic (\\>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.\n* Have been treated with drugs that promote weight loss within 90 days prior to study start.\n* Have been treated with drugs that directly affect gastrointestinal motility for \\> 21 consecutive days within 90 days prior to study start.\n* Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).\n* Have been treated for \\>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs\n* Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.\n* Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.\n* Have donated blood within 30 days prior to study start.","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Chief Medical Officer, MD","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Aomori","country":"Japan","geoPoint":{"lat":40.81667,"lon":140.73333}},{"facility":"Research Site","city":"Chiba","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Research Site","city":"Ehime","country":"Japan"},{"facility":"Research Site","city":"Fukuoka","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Research Site","city":"Gunma","country":"Japan"},{"facility":"Research Site","city":"Hiroshima","country":"Japan","geoPoint":{"lat":34.4,"lon":132.45}},{"facility":"Research Site","city":"Hokkaido","country":"Japan"},{"facility":"Research Site","city":"Hyōgo","country":"Japan","geoPoint":{"lat":43.36667,"lon":144.43333}},{"facility":"Research Site","city":"Ibaraki","country":"Japan","geoPoint":{"lat":34.81641,"lon":135.56828}},{"facility":"Research Site","city":"Kagawa","country":"Japan","geoPoint":{"lat":34.06667,"lon":131.03333}},{"facility":"Research Site","city":"Kanagawa","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"Research Site","city":"Kumamoto","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Research Site","city":"Kyoto","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"Research Site","city":"Nagano","country":"Japan","geoPoint":{"lat":36.65,"lon":138.18333}},{"facility":"Research Site","city":"Nagasaki","country":"Japan","geoPoint":{"lat":32.75,"lon":129.88333}},{"facility":"Research Site","city":"Nara","country":"Japan","geoPoint":{"lat":34.68505,"lon":135.80485}},{"facility":"Research Site","city":"Osaka","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Research Site","city":"Ōita","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}},{"facility":"Research Site","city":"Saitama","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"Research Site","city":"Shizuoka","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}},{"facility":"Research Site","city":"Tokyo","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Research Site","city":"Toyama","country":"Japan","geoPoint":{"lat":36.7,"lon":137.21667}}]},"referencesModule":{"references":[{"pmid":"32306296","type":"DERIVED","citation":"Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18."},{"pmid":"22884767","type":"DERIVED","citation":"Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012 Sep;34(9):1892-908.e1. doi: 10.1016/j.clinthera.2012.07.007. Epub 2012 Aug 9."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"FG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"215"},{"groupId":"FG001","numSubjects":"212"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"193"},{"groupId":"FG001","numSubjects":"201"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"11"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Subject Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Loss Glucose Control","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"BG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"215"},{"groupId":"BG001","value":"212"},{"groupId":"BG002","value":"427"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"160"},{"groupId":"BG001","value":"156"},{"groupId":"BG002","value":"316"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"55"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"111"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.1","spread":"10.44"},{"groupId":"BG001","value":"56.4","spread":"11.16"},{"groupId":"BG002","value":"56.8","spread":"10.80"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"64"},{"groupId":"BG002","value":"137"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"148"},{"groupId":"BG002","value":"290"}]}]}]},{"title":"Glycosylated hemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of total hemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.51","spread":"0.823"},{"groupId":"BG001","value":"8.50","spread":"0.791"},{"groupId":"BG002","value":"8.50","spread":"0.806"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"69.95","spread":"13.246"},{"groupId":"BG001","value":"71.03","spread":"13.932"},{"groupId":"BG002","value":"70.49","spread":"13.586"}]}]}]},{"title":"Background Oral Antidiabetic Agent (OAD)","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Biguanide (BG)","categories":[{"measurements":[{"groupId":"BG000","value":"145"},{"groupId":"BG001","value":"142"},{"groupId":"BG002","value":"287"}]}]},{"title":"BG+Thiazolidine Derivative (TZD)","categories":[{"measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"70"},{"groupId":"BG002","value":"140"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c From Baseline to Endpoint (Week 26)","description":"Change in HbA1c from baseline to endpoint (Week 26).","populationDescription":"Statistical analysis of this study was performed for the full analysis set (FAS). FAS consisted of randomized patients who received administration of the study drug at least once and had measurement values after administration. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.","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, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"212"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.11","spread":"0.06"},{"groupId":"OG001","value":"-0.68","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Noninferiority of exenatide QW to insulin glargine with respect to change in HbA1c was to be concluded if the upper limit of the 95% confidence interval (CI) for the treatment difference was less than 0.4%. Change in HbA1c from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, baseline HbA1c stratum (\\<8.5%, \\>=8.5%), background OAD, and presence/absence of pretreatment with SU as factors and baseline HbA1c as a covariate.","pValue":"<.001","pValueComment":"No adjustments for multiplicity will be performed","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-0.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.59","ciUpperLimit":"-0.26","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.08"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c<=7%","description":"Percentage of subjects achieving HbA1c \\<=7.0% (for subjects with HbA1c \\>7% at baseline)","populationDescription":"FAS Population. Only subjects with baseline HbA1c \\> target were included in calculation. Missing data at endpoint was imputed using LOCF approach.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42.2"},{"groupId":"OG001","value":"21.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Percentage of subjects achieving HbA1c\\<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c<=6.5%","description":"Percentage of subjects achieving HbA1c \\<=6.5% (for subjects with HbA1c \\>6.5% at baseline)","populationDescription":"FAS Population. Only subjects with baseline HbA1c \\> target were included in calculation. Missing data at endpoint was imputed using LOCF approach.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"212"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.6"},{"groupId":"OG001","value":"4.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Percentage of subjects achieving HbA1c\\<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)","description":"Change in FSG (centralized measurement) from baseline to endpoint (Week 26)","populationDescription":"FAS Population. Missing data at endpoint was imputed using LOCF approach.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"211"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-46.09","spread":"2.40"},{"groupId":"OG001","value":"-40.82","spread":"2.39"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.103","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-5.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.62","ciUpperLimit":"1.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.23"}]},{"type":"SECONDARY","title":"Change in Body Weight From Baseline to Endpoint (Week 26)","description":"Change in Body Weight from baseline to endpoint (Week 26)","populationDescription":"FAS Population. Missing data at endpoint was imputed using LOCF approach.","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, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"212"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.67","spread":"0.17"},{"groupId":"OG001","value":"0.34","spread":"0.17"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-2.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.46","ciUpperLimit":"-1.56","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.23"}]},{"type":"SECONDARY","title":"Change in Total Cholesterol From Baseline to Endpoint (Week 26)","description":"Change in Total Cholesterol from baseline to endpoint (Week 26)","populationDescription":"FAS Population. Missing data at endpoint was imputed using LOCF approach.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"212"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.21","spread":"1.67"},{"groupId":"OG001","value":"-6.32","spread":"1.67"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-7.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.33","ciUpperLimit":"-3.45","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.26"}]},{"type":"SECONDARY","title":"Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)","description":"Change in HDL-C from baseline to endpoint (Week 26)","populationDescription":"FAS Population. Missing data at endpoint was imputed using LOCF approach.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"212"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.99","spread":"0.52"},{"groupId":"OG001","value":"-0.71","spread":"0.51"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.689","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.64","ciUpperLimit":"1.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.69"}]},{"type":"SECONDARY","title":"Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline","description":"Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.","populationDescription":"FAS Population. Missing data at endpoint was imputed using LOCF approach.","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, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"212"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.02"},{"groupId":"OG001","value":"1.00","spread":"1.02"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.990","statisticalMethod":"ANCOVA","paramType":"Geometric Least Squares Mean Ratio","paramValue":"1.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.94","ciUpperLimit":"1.06","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.03"}]},{"type":"SECONDARY","title":"Change in Blood Pressure From Baseline to Endpoint (Week 26)","description":"Change in Blood Pressure from baseline to endpoint (Week 26)","populationDescription":"FAS Population. Missing data at endpoint was imputed using LOCF approach.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"212"}]}],"classes":[{"title":"Systolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-4.5","spread":"14.04"},{"groupId":"OG001","value":"-2.6","spread":"14.29"}]}]},{"title":"Diastolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"9.25"},{"groupId":"OG001","value":"-2.5","spread":"8.88"}]}]}]},{"type":"SECONDARY","title":"Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events","description":"Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.","populationDescription":"FAS 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","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"212"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events","description":"Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.","populationDescription":"FAS 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","description":"Subcutaneous injection, 2.0mg, once a week."},{"id":"OG001","title":"Insulin Glargine","description":"Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"212"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.01"},{"groupId":"OG001","value":"0.16","spread":"0.13"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection, 2.0mg, once a 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