{"protocolSection":{"identificationModule":{"nctId":"NCT00516048","orgStudyIdInfo":{"id":"H8O-MC-GWBO"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes","officialTitle":"An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-08"},"primaryCompletionDateStruct":{"date":"2008-04","type":"ACTUAL"},"completionDateStruct":{"date":"2008-04","type":"ACTUAL"},"studyFirstSubmitDate":"2007-08-10","studyFirstSubmitQcDate":"2007-08-10","studyFirstPostDateStruct":{"date":"2007-08-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-04-29","resultsFirstSubmitQcDate":"2009-04-29","resultsFirstPostDateStruct":{"date":"2009-06-17","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":"The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["exenatide","Byetta","antibodies","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":58,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide:Treatment-Emergent Antibody Negative","type":"EXPERIMENTAL","description":"This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.","interventionNames":["Drug: exenatide"]},{"label":"Exenatide:Treatment-Emergent Antibody 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study","timeFrame":"24 weeks"}],"secondaryOutcomes":[{"measure":"Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint","description":"Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status","timeFrame":"24 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes.\n* Have been exposed to exenatide for at least 3 months in previous Amylin/Lilly Studies H8O-MC-GWAO, H8O-MC-GWAP, H8O-MC-GWAT, or H8O-MC-GWBA.\n* Have interrupted exenatide treatment for a period of at least 2 months.\n* HbA1c of ≤10.5%.\n\nExclusion Criteria:\n\n* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.\n* Have previously completed or withdrawn from this study.\n* Have taken marketed exenatide (Byetta) during the interim period between studies GWAO, GWAP, GWAT, or GWBA and the current study.\n* Used drugs for weight loss (for example, Xenical® \\[orlistat\\], Meridia® \\[sibutramine\\], Acutrim® \\[phenylpropanolamine\\], Accomplia® \\[rimonabant\\], or similar over-the-counter medications) within 3 months of screening.\n* Are currently treated with any of the following excluded medications: Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.\n* Use insulin with daily dosage exceeding 1 U/kg.","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":"Keswick","state":"South Australia","country":"Australia","geoPoint":{"lat":-34.94178,"lon":138.57459}},{"facility":"Research Site","city":"Calgary","state":"Alberta","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"Research Site","city":"Vancouver","state":"British Columbia","country":"Canada","geoPoint":{"lat":49.24966,"lon":-123.11934}},{"facility":"Research Site","city":"London","state":"Ontario","country":"Canada","geoPoint":{"lat":42.98339,"lon":-81.23304}},{"facility":"Research Site","city":"Budapest","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Research Site","city":"Gyula","country":"Hungary","geoPoint":{"lat":46.65,"lon":21.28333}},{"facility":"Research Site","city":"Zalaegerszeg","country":"Hungary","geoPoint":{"lat":46.83695,"lon":16.84401}},{"facility":"Research Site","city":"Milan","country":"Italy","geoPoint":{"lat":45.46427,"lon":9.18951}},{"facility":"Research Site","city":"Perugia","country":"Italy","geoPoint":{"lat":43.1122,"lon":12.38878}},{"facility":"Research 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Ohman, Medical Science Director","organization":"AstraZeneca","email":"ClinicalTrialTransparency@astrazeneca.com"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"}],"ancestors":[{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D014688","term":"Venoms"},{"id":"D045424","term":"Complex Mixtures"},{"id":"D014118","term":"Toxins, Biological"},{"id":"D001685","term":"Biological Factors"}]}},"hasResults":true}