{"protocolSection":{"identificationModule":{"nctId":"NCT01003184","orgStudyIdInfo":{"id":"H8O-EW-GWDL"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes","officialTitle":"Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-10"},"primaryCompletionDateStruct":{"date":"2011-07","type":"ACTUAL"},"completionDateStruct":{"date":"2011-12","type":"ACTUAL"},"studyFirstSubmitDate":"2009-10-15","studyFirstSubmitQcDate":"2009-10-27","studyFirstPostDateStruct":{"date":"2009-10-28","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-11-20","resultsFirstSubmitQcDate":"2012-11-20","resultsFirstPostDateStruct":{"date":"2012-12-18","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 purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["diabetes","exenatide once weekly","Byetta","insulin detemir","Levemir","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":222,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide once weekly"]},{"label":"2","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: insulin detemir"]}],"interventions":[{"type":"DRUG","name":"exenatide once weekly","description":"subcutaneous injection, 2mg, once a week","armGroupLabels":["1"]},{"type":"DRUG","name":"insulin detemir","description":"subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day","armGroupLabels":["2"],"otherNames":["Levemir"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)","description":"The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c \\<=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.","timeFrame":"Baseline, Week 26"}],"secondaryOutcomes":[{"measure":"Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)","description":"Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)","timeFrame":"Baseline, Week 26"},{"measure":"Change in HbA1c From Baseline to Week 26","description":"Change in HbA1c from baseline to week 26","timeFrame":"Baseline, Week 26"},{"measure":"Change in Body Weight From Baseline to Week 26","description":"Change in body weight from baseline to week 26","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint","description":"Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint","timeFrame":"Week 26"},{"measure":"Percentage of Patients Achieving ≤7.0% at Endpoint","description":"Percentage of patients achieving ≤7.0% at endpoint.","timeFrame":"Week 26"},{"measure":"Percentage of Patients Achieving ≤6.5% at Endpoint","description":"Percentage of patients achieving HbA1c ≤6.5% at endpoint","timeFrame":"Week 26"},{"measure":"Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).","description":"Change in fasting serum glucose from baseline to endpoint (Week 26).","timeFrame":"Baseline, Week 26"},{"measure":"Changes in Systolic Blood Pressure From Baseline to Week 26","description":"Change in systolic blood pressure from baseline to Week 26","timeFrame":"Baseline, Week 26"},{"measure":"Change in Diastolic Blood Pressure From Baseline to Week 26.","description":"Change in diastolic blood pressure from baseline to week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Total Cholesterol From Baseline to Endpoint (Week 26).","description":"Change in total cholesterol from baseline to endpoint (week 26).","timeFrame":"Baseline, Week 26"},{"measure":"Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).","description":"Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).","timeFrame":"Baseline, Week 26"},{"measure":"Change in Triglycerides From Baseline to Endpoint (Week 26).","description":"Change in triglycerides from baseline to endpoint (week 26).","timeFrame":"Baseline, Week 26"},{"measure":"Hypoglycemia Rate Per Year","description":"All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) \\<3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement \\< 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.","timeFrame":"Baseline, Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive\n* Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive\n* Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start\n\nExclusion Criteria:\n\n* Have any contraindication for the OAD that they have been using\n* Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents\n* Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)\n* Have been treated with drugs that promote weight loss, within 3 months of screening\n* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors\n* Have previously completed or withdrawn from this study or any other study investigating exenatide QW\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* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 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":"Dublin","country":"Ireland","geoPoint":{"lat":53.33306,"lon":-6.24889}},{"facility":"Research Site","city":"Addlestone","state":"England","country":"United Kingdom","geoPoint":{"lat":51.37135,"lon":-0.49353}},{"facility":"Research Site","city":"Bath","state":"England","country":"United Kingdom","geoPoint":{"lat":51.3751,"lon":-2.36172}},{"facility":"Research Site","city":"Birmingham","state":"England","country":"United Kingdom","geoPoint":{"lat":52.48142,"lon":-1.89983}},{"facility":"Research Site","city":"Blackburn","state":"England","country":"United 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Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"6 patients who were enrolled and randomized, subsequently discontinued the study before receiving study drug. These patients were not included in analysis.","groups":[{"id":"FG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly : subcutaneous injection, 2mg, once a week"},{"id":"FG001","title":"Insulin Detemir","description":"Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"111"},{"groupId":"FG001","numSubjects":"111"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"111"},{"groupId":"FG001","numSubjects":"105"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"99"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"12"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Loss of glucose control","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly : subcutaneous injection, 2mg, once a week"},{"id":"BG001","title":"Insulin Detemir","description":"Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"111"},{"groupId":"BG001","value":"105"},{"groupId":"BG002","value":"216"}]}],"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":"74"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"152"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"64"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59.2","spread":"9.86"},{"groupId":"BG001","value":"57.8","spread":"9.48"},{"groupId":"BG002","value":"58.5","spread":"9.68"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"73"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"71"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"143"}]}]}]},{"title":"HbA1c","description":"At visit 3 (week 0).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of total hemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.4","spread":"0.85"},{"groupId":"BG001","value":"8.4","spread":"0.88"},{"groupId":"BG002","value":"8.4","spread":"0.86"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Kilograms","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"96.7","spread":"17.03"},{"groupId":"BG001","value":"97.9","spread":"15.82"},{"groupId":"BG002","value":"97.3","spread":"16.42"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)","description":"The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c \\<=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.","populationDescription":"The full analysis set (FAS) includes all data from all randomised patients receiving at least one dose of the study drug according to the treatment the patients were assigned.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percentage","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly : subcutaneous injection, 2mg, once a week"},{"id":"OG001","title":"Insulin Detemir","description":"Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"105"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"44.1","lowerLimit":"34.7","upperLimit":"53.9"},{"groupId":"OG001","value":"11.4","lowerLimit":"6.0","upperLimit":"19.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Primary objective: to test hypothesis that the percentage of patients with HbA1c ≤7.0% with weight loss (≥1.0 kg) after exenatide QW is superior to insulin detemir.\n\nSample size estimation: based on the test for difference in percentage between Exenatide QW and insulin detemir. Assuming: common drop-out rate 20%, response rate at endpoint 50% in the exenatide QW group and 25% in the insulin detemir group; 5% significance. 214 patients will provide 90% power to detect a difference.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","statisticalMethod":"Regression, Logistic","statisticalComment":"Logistic regression model includes treatment group, use of SU (yes/no), baseline HbA1c and baseline weight as main factors.","paramType":"Odds Ratio (OR)","paramValue":"6.60","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.17","ciUpperLimit":"13.73"}]},{"type":"SECONDARY","title":"Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)","description":"Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)","populationDescription":"The analysis was done for the FAS population (as randomised). For secondary analyses including both final HbA1c concentration and change in weight the last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percentage","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly : subcutaneous injection, 2mg, once a week"},{"id":"OG001","title":"Insulin Detemir","description":"Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"101"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58.9","lowerLimit":"49.0","upperLimit":"68.3"},{"groupId":"OG001","value":"17.8","lowerLimit":"10.9","upperLimit":"26.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","statisticalMethod":"Regression, Logistic","statisticalComment":"Logistic regression model includes the independent variables treatment group, use of SU (yes/no), baseline HbA1c and baseline weight.","paramType":"Odds Ratio (OR)","paramValue":"7.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.64","ciUpperLimit":"13.70"}]},{"type":"SECONDARY","title":"Change in HbA1c From Baseline to Week 26","description":"Change in HbA1c from baseline to week 26","populationDescription":"The analysis was done for the FAS population (as randomised).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of total hemoglobin","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly : subcutaneous injection, 2mg, once a week"},{"id":"OG001","title":"Insulin Detemir","description":"Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.32","spread":"0.076"},{"groupId":"OG001","value":"-0.91","spread":"0.077"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"-0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.104"}]},{"type":"SECONDARY","title":"Change in Body Weight From Baseline to Week 26","description":"Change in body weight from baseline to week 26","populationDescription":"The analysis was done for the FAS population (as randomised).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly : subcutaneous injection, 2mg, once a week"},{"id":"OG001","title":"Insulin 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