{"protocolSection":{"identificationModule":{"nctId":"NCT00877890","orgStudyIdInfo":{"id":"BCB108 (DURATION-5)"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)","officialTitle":"A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-03"},"primaryCompletionDateStruct":{"date":"2009-10","type":"ACTUAL"},"completionDateStruct":{"date":"2010-01","type":"ACTUAL"},"studyFirstSubmitDate":"2009-04-06","studyFirstSubmitQcDate":"2009-04-07","studyFirstPostDateStruct":{"date":"2009-04-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-02-14","resultsFirstSubmitQcDate":"2012-05-16","resultsFirstPostDateStruct":{"date":"2012-06-19","type":"ESTIMATED"},"dispFirstSubmitDate":"2011-06-17","dispFirstSubmitQcDate":"2011-06-17","dispFirstPostDateStruct":{"date":"2011-06-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-19","lastUpdatePostDateStruct":{"date":"2015-04-07","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["diabetes","exenatide once weekly","Byetta","Amylin","Lilly","Bydureon"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":254,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide once weekly"]},{"label":"2","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: exenatide twice daily"]}],"interventions":[{"type":"DRUG","name":"exenatide once weekly","description":"subcutaneous injection, 2.0mg, once a week","armGroupLabels":["1"],"otherNames":["BYDUREON"]},{"type":"DRUG","name":"exenatide twice daily","description":"subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day","armGroupLabels":["2"],"otherNames":["BYETTA"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c From Baseline to Week 24","description":"Change in HbA1c from baseline (Day 1) to Week 24 \\[Week 24 - Baseline\\].","timeFrame":"Day 1, Week 24"}],"secondaryOutcomes":[{"measure":"Percentage of Subjects Achieving HbA1c Target of <7%","description":"Percentages of subjects achieving HbA1c target value of \\<7% at Week 24.","timeFrame":"Week 24"},{"measure":"Percentage of Subjects Achieving HbA1c Target of <=6.5%","description":"Percentages of subjects achieving HbA1c target values of \\<=6.5% at Week 24.","timeFrame":"Week 24"},{"measure":"Change in Fasting Plasma Glucose From Baseline to Week 24","description":"Change in fasting plasma glucose from baseline (Day 1) to Week 24.","timeFrame":"Day 1, Week 24"},{"measure":"Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL","description":"Percentages of subjects achieving fasting plasma glucose target of \\<=126 mg/dL at Week 24.","timeFrame":"Week 24"},{"measure":"Change in Body Weight From Baseline to Week 24","description":"Change in body weight from baseline (Day 1) to Week 24.","timeFrame":"Day 1, Week 24"},{"measure":"Change in Sitting Systolic Blood Pressure From Baseline to Week 24","description":"Change in systolic blood pressure from baseline (Day 1) to Week 24.","timeFrame":"Day 1, Week 24"},{"measure":"Change in Sitting Diastolic Blood Pressure From Baseline to Week 24","description":"Change in diastolic blood pressure from baseline (Day 1) to Week 24.","timeFrame":"Day 1, Week 24"},{"measure":"Change in Total Cholesterol From Baseline to Week 24","description":"Change in total cholesterol from baseline (Day 1) to Week 24.","timeFrame":"Day 1, Week 24"},{"measure":"Change in High-density Lipoprotein (HDL) From Baseline to Week 24","description":"Change in HDL from baseline (Day 1) to Week 24.","timeFrame":"Day 1, Week 24"},{"measure":"Ratio of Triglycerides at Week 24 to Baseline","description":"Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.","timeFrame":"Day 1, Week 24"},{"measure":"Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events","description":"The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.","timeFrame":"Day 1 to Week 24"},{"measure":"Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events","description":"The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.","timeFrame":"Day 1 to Week 24"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Has been diagnosed with type 2 diabetes mellitus\n* Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening\n* Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening\n* Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening\n* Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:\n\n  * Hormone replacement therapy (female subjects)\n  * Oral contraceptives (female subjects)\n  * Antihypertensive agents\n  * Lipid-lowering agents\n  * Thyroid replacement therapy\n  * Antidepressant agents\n  * Drugs known to affect body weight, including prescription medications (e.g. orlistat \\[XENICAL®\\], sibutramine \\[MERIDIA®\\], topiramate \\[TOPAMAX®\\]) and over the counter antiobesity agents\n\nExclusion Criteria:\n\n* Has ever been exposed to exenatide (exenatide once weekly \\[exenatide LAR\\], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog\n* Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening\n* Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:\n\n  * Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening\n  * Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening\n  * Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening\n  * Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Lisa Porter, MD","affiliation":"Amylin Pharmaceuticals, LLC.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Birmingham","state":"Alabama","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Research Site","city":"Mesa","state":"Arizona","country":"United States","geoPoint":{"lat":33.42227,"lon":-111.82264}},{"facility":"Research Site","city":"Peoria","state":"Arizona","country":"United 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DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011 May;96(5):1301-10. doi: 10.1210/jc.2010-2081. Epub 2011 Feb 9."},{"pmid":"27146799","type":"DERIVED","citation":"Blevins T, Ruggles J, Hardy E. Onset of Glycemic and Weight Outcomes in Patients Initiating Exenatide Once Weekly: The Relationship of Exenatide Exposure with Efficacy over the First 24 Weeks of Treatment. Diabetes Ther. 2016 Jun;7(2):361-8. doi: 10.1007/s13300-016-0172-0. Epub 2016 May 5."},{"pmid":"23748506","type":"DERIVED","citation":"Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. 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":"23039868","type":"DERIVED","citation":"Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125."},{"pmid":"22236356","type":"DERIVED","citation":"Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"FG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"129"},{"groupId":"FG001","numSubjects":"125"}]},{"type":"Intent to Treat (ITT)","achievements":[{"groupId":"FG000","numSubjects":"129"},{"groupId":"FG001","numSubjects":"123"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"95"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"30"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"Investigator Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Loss of Glucose Control","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"BG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"129"},{"groupId":"BG001","value":"123"},{"groupId":"BG002","value":"252"}]}],"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":"103"},{"groupId":"BG001","value":"102"},{"groupId":"BG002","value":"205"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"47"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.1","spread":"11.14"},{"groupId":"BG001","value":"55.2","spread":"10.27"},{"groupId":"BG002","value":"55.7","spread":"10.71"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"107"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"145"}]}]}]},{"title":"Glycosylated hemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of total hemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.5","spread":"1.10"},{"groupId":"BG001","value":"8.4","spread":"1.23"},{"groupId":"BG002","value":"8.4","spread":"1.16"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"97.0","spread":"20.66"},{"groupId":"BG001","value":"94.3","spread":"18.94"},{"groupId":"BG002","value":"95.7","spread":"19.85"}]}]}]},{"title":"Background Oral Antidiabetic Agent","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Diet and Exercise","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"47"}]}]},{"title":"Metformin (MET)","categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"103"}]}]},{"title":"Sulfonylurea (SU)","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"}]}]},{"title":"Thiazolidinediones (TZD)","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"6"}]}]},{"title":"MET+SU","categories":[{"measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"59"}]}]},{"title":"MET+TZD","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"22"}]}]},{"title":"SU+MET+TZD","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c From Baseline to Week 24","description":"Change in HbA1c from baseline (Day 1) to Week 24 \\[Week 24 - Baseline\\].","populationDescription":"The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 24 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of total hemoglobin","timeFrame":"Day 1, Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"116"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.57","spread":"0.104","lowerLimit":"-1.77","upperLimit":"-1.36"},{"groupId":"OG001","value":"-0.90","spread":"0.110","lowerLimit":"-1.12","upperLimit":"-0.69"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Superiority of exenatide once weekly to BYETTA if the upper limit of the 2-sided 95% CI for treatment difference (exenatide once weekly minus BYETTA) is \\<0; noninferiority if this upper limit is \\<0.4%. Power: Assuming 15% dropout rate with 206 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in exenatide once weekly and a common standard deviation of 1.1%.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide once weekly and BYETTA, regulatory guidance, published literature, and statistical considerations.","pValue":"<.0001","statisticalMethod":"ANOVA","statisticalComment":"Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors.","paramType":"Least Squares Mean Difference","paramValue":"-0.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.94","ciUpperLimit":"-0.39","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.138"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c Target of <7%","description":"Percentages of subjects achieving HbA1c target value of \\<7% at Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"123"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58.1"},{"groupId":"OG001","value":"30.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Percentages of subjects achieving HbA1c target value of \\<7% at Week 24 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\\<9% or \\>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","pValueComment":"Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \\<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \\<=126 mg/dL) was performed.","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c Target of <=6.5%","description":"Percentages of subjects achieving HbA1c target values of \\<=6.5% at Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"123"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41.1"},{"groupId":"OG001","value":"16.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Percentages of subjects achieving HbA1c target values of \\<=6.5% at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\\<9% or \\>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose From Baseline to Week 24","description":"Change in fasting plasma glucose from baseline (Day 1) to Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Day 1, Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"117"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-25.1","spread":"4.32","lowerLimit":"-33.6","upperLimit":"-16.6"},{"groupId":"OG001","value":"-4.6","spread":"4.50","lowerLimit":"-13.5","upperLimit":"4.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0006","pValueComment":"Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \\<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \\<=126 mg/dL) was performed.","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-20.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-31.4","ciUpperLimit":"-9.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.57"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL","description":"Percentages of subjects achieving fasting plasma glucose target of \\<=126 mg/dL at Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"123"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50.4"},{"groupId":"OG001","value":"30.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Percentages of subjects achieving fasting plasma glucose target of \\<=126 mg/dL at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\\<9% or \\>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving fasting plasma glucose target. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0008","pValueComment":"Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \\<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \\<=126 mg/dL) was performed.","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change in Body Weight From Baseline to Week 24","description":"Change in body weight from baseline (Day 1) to Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Day 1, Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.33","spread":"0.369","lowerLimit":"-3.05","upperLimit":"-1.60"},{"groupId":"OG001","value":"-1.37","spread":"0.386","lowerLimit":"-2.13","upperLimit":"-0.61"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in body weight from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0514","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-0.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.91","ciUpperLimit":"0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.487"}]},{"type":"SECONDARY","title":"Change in Sitting Systolic Blood Pressure From Baseline to Week 24","description":"Change in systolic blood pressure from baseline (Day 1) to Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Day 1, Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.9","spread":"1.13","lowerLimit":"-5.2","upperLimit":"-0.7"},{"groupId":"OG001","value":"-1.2","spread":"1.19","lowerLimit":"-3.5","upperLimit":"1.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the systolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline systolic blood pressure. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2367","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-1.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.7","ciUpperLimit":"1.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.50"}]},{"type":"SECONDARY","title":"Change in Sitting Diastolic Blood Pressure From Baseline to Week 24","description":"Change in diastolic blood pressure from baseline (Day 1) to Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Day 1, Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.74","lowerLimit":"-1.3","upperLimit":"1.6"},{"groupId":"OG001","value":"-0.1","spread":"0.78","lowerLimit":"-1.7","upperLimit":"1.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the diastolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline diastolic blood pressure. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7717","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.7","ciUpperLimit":"2.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.98"}]},{"type":"SECONDARY","title":"Change in Total Cholesterol From Baseline to Week 24","description":"Change in total cholesterol from baseline (Day 1) to Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Day 1, Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.4","spread":"2.61","lowerLimit":"-20.5","upperLimit":"-10.2"},{"groupId":"OG001","value":"0.6","spread":"2.79","lowerLimit":"-4.9","upperLimit":"6.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in total cholesterol from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-16.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-22.9","ciUpperLimit":"-9.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.50"}]},{"type":"SECONDARY","title":"Change in High-density Lipoprotein (HDL) From Baseline to Week 24","description":"Change in HDL from baseline (Day 1) to Week 24.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Day 1, Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.60","lowerLimit":"-1.2","upperLimit":"1.2"},{"groupId":"OG001","value":"1.3","spread":"0.64","lowerLimit":"0.0","upperLimit":"2.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in HDL from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1251","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-1.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.8","ciUpperLimit":"0.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.80"}]},{"type":"SECONDARY","title":"Ratio of Triglycerides at Week 24 to Baseline","description":"Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.","populationDescription":"ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"Day 1, Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week"},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"0.032","lowerLimit":"0.88","upperLimit":"1.00"},{"groupId":"OG001","value":"0.99","spread":"0.036","lowerLimit":"0.92","upperLimit":"1.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day 1) , expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2558","statisticalMethod":"ANCOVA","paramType":"Geometric Least Squares Mean Ratio","paramValue":"0.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.87","ciUpperLimit":"1.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.043"}]},{"type":"SECONDARY","title":"Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events","description":"The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.","populationDescription":"ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"rate per subject-year","timeFrame":"Day 1 to Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly With SU","description":"Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening"},{"id":"OG001","title":"Exenatide Twice Daily With SU","description":"Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening"},{"id":"OG002","title":"Exenatide Once Weekly No SU","description":"Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening"},{"id":"OG003","title":"Exenatide Twice Daily No SU","description":"Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"89"},{"groupId":"OG003","value":"89"}]}],"classes":[{"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"}]}]}]},{"type":"SECONDARY","title":"Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events","description":"The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.","populationDescription":"ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"rate per subject-year","timeFrame":"Day 1 to Week 24","groups":[{"id":"OG000","title":"Exenatide Once Weekly With SU","description":"Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening"},{"id":"OG001","title":"Exenatide Twice Daily With SU","description":"Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening"},{"id":"OG002","title":"Exenatide Once Weekly No SU","description":"Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening"},{"id":"OG003","title":"Exenatide Twice Daily No SU","description":"Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"89"},{"groupId":"OG003","value":"89"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.75","spread":"0.217"},{"groupId":"OG001","value":"0.31","spread":"0.153"},{"groupId":"OG002","value":"0.00","spread":"0.000"},{"groupId":"OG003","value":"0.00","spread":"0.000"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week","seriousNumAffected":3,"seriousNumAtRisk":129,"otherNumAffected":44,"otherNumAtRisk":129},{"id":"EG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 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