{"protocolSection":{"identificationModule":{"nctId":"NCT00434954","orgStudyIdInfo":{"id":"H8O-SB-GWBN"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes","officialTitle":"Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-02"},"primaryCompletionDateStruct":{"date":"2009-06","type":"ACTUAL"},"completionDateStruct":{"date":"2009-06","type":"ACTUAL"},"studyFirstSubmitDate":"2007-02-12","studyFirstSubmitQcDate":"2007-02-12","studyFirstPostDateStruct":{"date":"2007-02-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-06-25","resultsFirstSubmitQcDate":"2010-07-30","resultsFirstPostDateStruct":{"date":"2010-08-23","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 in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["diabetes","exenatide","Byetta","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":494,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide Twice Daily (BID)","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide twice daily (BID)"]},{"label":"Premixed Insulin Aspart Twice Daily (BID)","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: premixed insulin aspart twice daily (BID)"]}],"interventions":[{"type":"DRUG","name":"exenatide twice daily (BID)","description":"subcutaneous injection (5 mcg or 10 mcg), twice a day","armGroupLabels":["Exenatide Twice Daily (BID)"],"otherNames":["Byetta"]},{"type":"DRUG","name":"premixed insulin aspart twice daily (BID)","description":"subcutaneous injection (titrated appropriately), twice a day","armGroupLabels":["Premixed Insulin Aspart Twice Daily (BID)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycosylated Hemoglobin (HbA1c)","description":"Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)","timeFrame":"Baseline and 26 weeks"},{"measure":"Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)","description":"Risk for first hypoglycemic episode (blood glucose \\<=3.9 mmol/L or severe episode) to occur up to week 26","timeFrame":"26 weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Subjects Achieving HbA1c Target of < 6.5%","description":"Percentage of subjects achieving HbA1c target of \\< 6.5% at the end of study (week 26) \\[i.e., number of subjects who achieved HbA1c \\< 6.5% divided by total number of subjects times 100%\\].","timeFrame":"26 weeks"},{"measure":"Percentage of Subjects Achieving HbA1c Target of < 7.0%","description":"Percentage of subjects achieving HbA1c target of \\< 7.0% at the end of study (week 26) \\[i.e., number of subjects who achieved HbA1c \\< 7.0% divided by total number of subjects times 100%\\].","timeFrame":"26 weeks"},{"measure":"Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)","description":"Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)\\[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%\\]","timeFrame":"26 weeks"},{"measure":"Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)","description":"Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) \\[i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%\\].","timeFrame":"26 weeks"},{"measure":"7 Point Self-monitored Blood Glucose (SMBG) Profiles","description":"7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).","timeFrame":"Baseline and 26 weeks"},{"measure":"Blood Lipid Levels","description":"Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)","timeFrame":"Baseline and 26 weeks"},{"measure":"Change in Body Weight","description":"Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)","timeFrame":"Baseline and 26 weeks"},{"measure":"Change in Body Mass Index (BMI)","description":"Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)","timeFrame":"Baseline and 26 weeks"},{"measure":"Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)","description":"Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.","timeFrame":"Baseline and 26 weeks"},{"measure":"Patient Reported Outcomes: Quality of Life (SF-12)","description":"SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores \\> 50 indicate an above-average health status.","timeFrame":"Baseline and 26 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start\n* Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start\n* Have an HbA1c between 6.5% and 10.0%, inclusive\n* Have a body mass index (BMI) between 25 kg/m\\^2 and 40 kg/m\\^2, inclusive\n\nExclusion Criteria:\n\n* Have type 1 diabetes or known latent autoimmune diabetes in adults\n* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start\n* Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)\n* Have used any prescription drug to promote weight loss within 3 months prior to study start\n* Have received treatment within 30 days prior to study start 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 or any other study investigating exenatide or GLP-1 analogs","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"90 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":"Bad 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Site","city":"Warburg","country":"Germany","geoPoint":{"lat":51.49011,"lon":9.14641}},{"facility":"Research Site","city":"Wiesbaden","country":"Germany","geoPoint":{"lat":50.08601,"lon":8.24435}},{"facility":"Research Site","city":"Wolfsburg","country":"Germany","geoPoint":{"lat":52.4236,"lon":10.77597}}]},"referencesModule":{"references":[{"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":"21285388","type":"DERIVED","citation":"Gallwitz B, Bohmer M, Segiet T, Molle A, Milek K, Becker B, Helsberg K, Petto H, Peters N, Bachmann O. Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia. Diabetes Care. 2011 Mar;34(3):604-6. doi: 10.2337/dc10-1900. Epub 2011 Feb 1."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients treated with metformin (MET only;confirmatory population used for primary analysis) and additional patients treated with metformin plus either sulfonylurea or meglitinide (MET+SU; exploratory population) were enrolled at a 3:1 ratio; metformin was continued.Within each population, patients were then randomly assigned 1:1 to study treatment","groups":[{"id":"FG000","title":"Exenatide Twice Daily","description":"Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks"},{"id":"FG001","title":"Premixed Insulin Aspart Twice Daily","description":"Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"248"},{"groupId":"FG001","numSubjects":"246"}]},{"type":"Started - Previous Treatment MET Only","achievements":[{"groupId":"FG000","numSubjects":"182"},{"groupId":"FG001","numSubjects":"181"}]},{"type":"Started - Previous Treatment MET + SU","achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"65"}]},{"type":"Full Analysis Set (FAS) Overall","achievements":[{"groupId":"FG000","comment":"FAS=received \\>=1 dose of study drug. Adverse event data reported for Overall FAS.","numSubjects":"247"},{"groupId":"FG001","comment":"FAS=received \\>=1 dose of study drug. Adverse event data reported for Overall FAS.","numSubjects":"233"}]},{"type":"FAS - Previous Treatment MET Only","achievements":[{"groupId":"FG000","comment":"Baseline and efficacy data reported for \"FAS-Previous Treatment MET Only\" group.","numSubjects":"181"},{"groupId":"FG001","comment":"Baseline and efficacy data reported for \"FAS-Previous Treatment MET Only\" group.","numSubjects":"173"}]},{"type":"FAS - Previous Treatment MET + SU","achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"60"}]},{"type":"Completed - Previous Treatment MET Only","achievements":[{"groupId":"FG000","numSubjects":"135"},{"groupId":"FG001","numSubjects":"137"}]},{"type":"Completed - Previous Treatment MET + SU","achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"38"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"166"},{"groupId":"FG001","numSubjects":"175"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"82"},{"groupId":"FG001","numSubjects":"71"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Entry criteria not met","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"27"}]},{"type":"Sponsor decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Subject decision","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"22"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide Twice Daily","description":"Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks"},{"id":"BG001","title":"Premixed Insulin Aspart Twice Daily","description":"Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"181"},{"groupId":"BG001","value":"173"},{"groupId":"BG002","value":"354"}]}],"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":"138"},{"groupId":"BG001","value":"133"},{"groupId":"BG002","value":"271"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"83"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.2","spread":"10.03"},{"groupId":"BG001","value":"56.9","spread":"9.94"},{"groupId":"BG002","value":"57.1","spread":"9.97"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"150"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"108"},{"groupId":"BG001","value":"96"},{"groupId":"BG002","value":"204"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg / m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33.4","spread":"4.23"},{"groupId":"BG001","value":"32.9","spread":"4.37"},{"groupId":"BG002","value":"33.2","spread":"4.30"}]}]}]},{"title":"Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"99.4","spread":"16.22"},{"groupId":"BG001","value":"96.6","spread":"17.40"},{"groupId":"BG002","value":"98.0","spread":"16.85"}]}]}]},{"title":"Duration of Diabetes","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.8","spread":"4.39"},{"groupId":"BG001","value":"5.2","spread":"4.67"},{"groupId":"BG002","value":"5.0","spread":"4.53"}]}]}]},{"title":"Glycosylated hemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.89","spread":"0.822"},{"groupId":"BG001","value":"7.88","spread":"0.918"},{"groupId":"BG002","value":"7.88","spread":"0.869"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Glycosylated Hemoglobin (HbA1c)","description":"Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)","populationDescription":"All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of glycosylated hemoglobin","timeFrame":"Baseline and 26 weeks","groups":[{"id":"OG000","title":"Exenatide Twice Daily","description":"Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks"},{"id":"OG001","title":"Premixed Insulin Aspart Twice Daily","description":"Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"181"},{"groupId":"OG001","value":"173"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.00","spread":"0.05"},{"groupId":"OG001","value":"-1.14","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart 70/30 BID for glycemic control (change in HbA1c, outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2). This is the first part of the hierarchical test.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"The planned sample size of 366 patients treated with metformin only (assuming 25% dropouts) gave a power of 85% to detect non-inferiority of exenatide BID for change in HbA1c (non-inferiority margin 0.4%; assumed common standard deviation of 1.1%).","pValue":"0.055","pValueComment":"Non-inferiority: upper limit of 95% Confidence Interval (CI) to be \\< 0.4%.","statisticalMethod":"Mixed effect model repeat measures(MMRM)","statisticalComment":"95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects); p-value: superiority test","paramType":"Mean Difference (Net)","paramValue":"0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.003","ciUpperLimit":"0.291"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c Target of < 6.5%","description":"Percentage of subjects achieving HbA1c target of \\< 6.5% at the end of study (week 26) \\[i.e., number of subjects who achieved HbA1c \\< 6.5% divided by total number of subjects times 100%\\].","populationDescription":"All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); 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