{"protocolSection":{"identificationModule":{"nctId":"NCT00082407","orgStudyIdInfo":{"id":"H8O-MC-GWAD"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin","officialTitle":"Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2003-11"},"primaryCompletionDateStruct":{"date":"2008-07","type":"ACTUAL"},"completionDateStruct":{"date":"2008-07","type":"ACTUAL"},"studyFirstSubmitDate":"2004-05-06","studyFirstSubmitQcDate":"2004-05-07","studyFirstPostDateStruct":{"date":"2004-05-10","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-07-16","resultsFirstSubmitQcDate":"2013-06-25","resultsFirstPostDateStruct":{"date":"2013-07-31","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 is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c)."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["diabetes","exendin","Amylin","Lilly","insulin aspart"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":505,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide Arm","type":"EXPERIMENTAL","description":"subcutaneous injection, twice daily; 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2UH","country":"United Kingdom","geoPoint":{"lat":52.9536,"lon":-1.15047}},{"facility":"Diabetes Trial Unit OCDEM, Churchill Hospital","city":"Oxford","zip":"OX3 7LJ","country":"United Kingdom","geoPoint":{"lat":51.75222,"lon":-1.25596}},{"facility":"Diabetes Unit, Gladsone Centre, Maelor Hospital","city":"Wrexham","zip":"LL13 7TD","country":"United Kingdom","geoPoint":{"lat":53.04664,"lon":-2.99132}}]},"referencesModule":{"references":[{"pmid":"17160407","type":"RESULT","citation":"Nauck MA, Duran S, Kim D, Johns D, Northrup J, Festa A, Brodows R, Trautmann M. A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia. 2007 Feb;50(2):259-67. doi: 10.1007/s00125-006-0510-2. Epub 2006 Dec 8."},{"pmid":"22913891","type":"DERIVED","citation":"Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567."},{"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":{"preAssignmentDetails":"Four patients withdrew from the study prior to receiving study drug.","groups":[{"id":"FG000","title":"Exenatide Arm","description":"subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks"},{"id":"FG001","title":"Biphasic Insulin Aspart Arm","description":"subcutaneous injection, twice daily; titration to target blood glucose level"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"255"},{"groupId":"FG001","numSubjects":"250"}]},{"type":"Received Treatment (Intent to Treat)","achievements":[{"groupId":"FG000","numSubjects":"253"},{"groupId":"FG001","numSubjects":"248"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"199"},{"groupId":"FG001","numSubjects":"223"}]},{"type":"NOT 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