{"protocolSection":{"identificationModule":{"nctId":"NCT00577824","orgStudyIdInfo":{"id":"H8O-JE-GWBB"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)","officialTitle":"Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-01"},"primaryCompletionDateStruct":{"date":"2008-11","type":"ACTUAL"},"completionDateStruct":{"date":"2008-11","type":"ACTUAL"},"studyFirstSubmitDate":"2007-12-18","studyFirstSubmitQcDate":"2007-12-18","studyFirstPostDateStruct":{"date":"2007-12-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-11-23","resultsFirstSubmitQcDate":"2009-11-23","resultsFirstPostDateStruct":{"date":"2009-12-31","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":"This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["diabetes","exenatide","LY2148568","Byetta","Lilly","Amylin"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":181,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide"]},{"label":"2","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide"]},{"label":"3","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"subcutaneous injection, 5mcg, twice a day","armGroupLabels":["1"],"otherNames":["LY2148568","Byetta"]},{"type":"DRUG","name":"exenatide","description":"subcutaneous injection, 10mcg, twice a day","armGroupLabels":["2"],"otherNames":["LY2148568","Byetta"]},{"type":"DRUG","name":"placebo","description":"subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day","armGroupLabels":["3"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24","description":"Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)","timeFrame":"baseline, 24 weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Patients Achieving HbA1c < 7.0%","description":"Percentage of subjects whose HbA1c was \\>=7.0% at baseline who achieved an HbA1c \\< 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c \\< 7.0% divided by total number of eligible subjects times 100)","timeFrame":"24 weeks"},{"measure":"Percentage of Patients Achieving HbA1c < 6.5%","description":"Percentage of subjects whose HbA1c was \\>=6.5% at baseline who achieved an HbA1c \\< 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c \\< 6.5% divided by total number of eligible subjects times 100)","timeFrame":"24 weeks"},{"measure":"Change in Fasting Blood Glucose","description":"Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in Body Weight","description":"Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in Total Cholesterol","description":"Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in Low Density Lipoprotein Cholesterol (LDL-C)","description":"Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in High Density Lipoprotein Cholesterol (HDL-C)","description":"Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in Triglycerides","description":"Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in Waist Size","description":"Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in Waist-to-hip Ratio","description":"Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.","timeFrame":"baseline, week 24"},{"measure":"7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24","description":"Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).","timeFrame":"baseline, week 24"},{"measure":"Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)","description":"Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.","timeFrame":"baseline, week 24"},{"measure":"Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)","description":"Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.","timeFrame":"baseline, week 24"},{"measure":"Change in Serum Insulin","description":"Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in C-peptide","description":"Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)","timeFrame":"baseline, week 24"},{"measure":"Change in 1,5-anhydroglucitol","description":"Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)","timeFrame":"baseline, week 24"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes.\n* Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.\n* Have HbA1c 7.0% to 10% at study start.\n* Have a body weight \\>=50 kg.\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 participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.\n* Have been treated with any exogenous insulin within 90 days before study start.\n* Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.\n* The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","maximumAge":"75 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":"Chiba","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Research Site","city":"Fukuoka","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Research Site","city":"Fukushima","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"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":"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":"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":"Tokyo","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}}]},"referencesModule":{"references":[{"pmid":"24843486","type":"RESULT","citation":"Kadowaki T, Namba M, Imaoka T, Yamamura A, Goto W, Boardman MK, Sowa H. Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks. J Diabetes Investig. 2011 Jun 5;2(3):210-7. doi: 10.1111/j.2040-1124.2010.00084.x."},{"pmid":"24843529","type":"RESULT","citation":"Inagaki N, Ueki K, Yamamura A, Saito H, Imaoka T. Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes. J Diabetes Investig. 2011 Nov 30;2(6):448-56. doi: 10.1111/j.2040-1124.2011.00137.x."},{"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."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"5mcg Exenatide BID","description":"exenatide SC 5mcg, twice daily"},{"id":"FG001","title":"10mcg Exenatide BID","description":"exenatide SC 10mcg, twice daily"},{"id":"FG002","title":"Placebo BID","description":"placebo SC, twice daily"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Started=Randomized","numSubjects":"72"},{"groupId":"FG001","numSubjects":"73"},{"groupId":"FG002","numSubjects":"36"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","comment":"Full Analysis Set=subject received at least one dose of study medication (active or placebo)","numSubjects":"72"},{"groupId":"FG001","numSubjects":"72"},{"groupId":"FG002","numSubjects":"35"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"65"},{"groupId":"FG001","numSubjects":"53"},{"groupId":"FG002","numSubjects":"34"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Patient decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"5mcg Exenatide BID","description":"exenatide SC 5mcg, twice daily"},{"id":"BG001","title":"10mcg Exenatide BID","description":"exenatide SC 10mcg, twice daily"},{"id":"BG002","title":"Placebo BID","description":"placebo SC, twice daily"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"72"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"35"},{"groupId":"BG003","value":"179"}]}],"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"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"126"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"53"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.5","spread":"9.33"},{"groupId":"BG001","value":"59.4","spread":"9.75"},{"groupId":"BG002","value":"56.3","spread":"11.41"},{"groupId":"BG003","value":"58.4","spread":"9.94"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"57"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"122"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24","description":"Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)","populationDescription":"Full analysis set; 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Last observation carried forward. Only those patients with HbA1c \\>=7% at baseline included.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"5mcg Exenatide BID","description":"exenatide SC 5mcg, twice daily"},{"id":"OG001","title":"10mcg Exenatide BID","description":"exenatide SC 10mcg, twice daily"},{"id":"OG002","title":"Placebo BID","description":"placebo SC, twice daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67.1"},{"groupId":"OG001","value":"71.0"},{"groupId":"OG002","value":"15.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Armitage","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving HbA1c < 6.5%","description":"Percentage of subjects whose HbA1c was \\>=6.5% at baseline who achieved an HbA1c \\< 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c \\< 6.5% divided by total number of eligible subjects times 100)","populationDescription":"Full analysis set; Last observation carried forward. Only subjects whose HbA1c was \\>=6.5% at baseline were included.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"5mcg Exenatide BID","description":"exenatide SC 5mcg, twice daily"},{"id":"OG001","title":"10mcg Exenatide BID","description":"exenatide SC 10mcg, twice daily"},{"id":"OG002","title":"Placebo BID","description":"placebo SC, twice daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"72"},{"groupId":"OG002","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36.6"},{"groupId":"OG001","value":"47.2"},{"groupId":"OG002","value":"8.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Armitage","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Fasting Blood Glucose","description":"Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)","populationDescription":"Full analysis set; Last observation carried forward","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"baseline, week 24","groups":[{"id":"OG000","title":"5mcg Exenatide BID","description":"exenatide SC 5mcg, twice daily"},{"id":"OG001","title":"10mcg Exenatide BID","description":"exenatide SC 10mcg, twice daily"},{"id":"OG002","title":"Placebo BID","description":"placebo SC, twice daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"72"},{"groupId":"OG002","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-25.1","spread":"3.83"},{"groupId":"OG001","value":"-29.0","spread":"3.81"},{"groupId":"OG002","value":"-7.6","spread":"5.46"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.002","pValueComment":"No adjustment for multiplicity. Significance level was 5% (two-sided).","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)","populationDescription":"Full analysis set; Last observation carried forward","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"baseline, week 24","groups":[{"id":"OG000","title":"5mcg Exenatide BID","description":"exenatide SC 5mcg, twice daily"},{"id":"OG001","title":"10mcg Exenatide BID","description":"exenatide SC 10mcg, twice daily"},{"id":"OG002","title":"Placebo BID","description":"placebo SC, twice daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"72"},{"groupId":"OG002","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.39","spread":"0.28"},{"groupId":"OG001","value":"-1.54","spread":"0.27"},{"groupId":"OG002","value":"-0.47","spread":"0.39"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.026","pValueComment":"No adjustment for multiplicity. Significance level was 5% (two-sided).","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Total Cholesterol","description":"Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)","populationDescription":"Full analysis set; Last observation carried forward","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"baseline, week 24","groups":[{"id":"OG000","title":"5mcg Exenatide BID","description":"exenatide SC 5mcg, twice daily"},{"id":"OG001","title":"10mcg Exenatide BID","description":"exenatide SC 10mcg, twice daily"},{"id":"OG002","title":"Placebo BID","description":"placebo SC, twice daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"72"},{"groupId":"OG002","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.45","spread":"3.36"},{"groupId":"OG001","value":"-7.01","spread":"3.13"},{"groupId":"OG002","value":"-4.80","spread":"3.76"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.672","statisticalMethod":"t-test, 2 sided","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Low Density Lipoprotein Cholesterol (LDL-C)","description":"Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)","populationDescription":"Full analysis set; 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