{"protocolSection":{"identificationModule":{"nctId":"NCT00360334","orgStudyIdInfo":{"id":"H8O-BP-GWBG"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients","officialTitle":"An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-06"},"primaryCompletionDateStruct":{"date":"2008-04","type":"ACTUAL"},"completionDateStruct":{"date":"2008-04","type":"ACTUAL"},"studyFirstSubmitDate":"2006-08-02","studyFirstSubmitQcDate":"2006-08-02","studyFirstPostDateStruct":{"date":"2006-08-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-04-14","resultsFirstSubmitQcDate":"2009-04-14","resultsFirstPostDateStruct":{"date":"2009-06-05","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 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["diabetes","exenatide","insulin glargine","Lilly","Amylin"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":235,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide"]},{"label":"2","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: insulin glargine"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"subcutaneous injection, 5mcg or 10mcg, twice a day","armGroupLabels":["1"],"otherNames":["Byetta"]},{"type":"DRUG","name":"insulin glargine","description":"subcutaneous injection, titrated to target blood glucose level, once a day","armGroupLabels":["2"],"otherNames":["Lantus"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)","description":"Composite endpoint evaluating effect of treatment on glycemic control and weight","timeFrame":"26 weeks"}],"secondaryOutcomes":[{"measure":"Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg","description":"Composite endpoint evaluating effect of treatment on glycemic control and weight","timeFrame":"26 weeks"},{"measure":"Change in Fasting Serum Glucose","description":"Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)","timeFrame":"26 weeks"},{"measure":"Percent of Patients Achieving HbA1c ≤ 7.4%","description":"Percent of patients achieving specified HbA1c target at endpoint","timeFrame":"26 weeks"},{"measure":"Percent of Patients Achieving HbA1c < 7%","description":"Percent of patients achieving specified HbA1c target at endpoint","timeFrame":"26 weeks"},{"measure":"Percent of Patients Achieving HbA1c < 6.5%","description":"Percent of patients achieving specified HbA1c target at endpoint","timeFrame":"26 weeks"},{"measure":"Change in 7 Point Self Monitored Blood Glucose Profile","description":"Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day","timeFrame":"26 weeks"},{"measure":"Change in Body Mass Index (BMI)","description":"Change in BMI from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference from baseline to endpoint","timeFrame":"26 Weeks"},{"measure":"Change in Waist-to-hip Ratio","description":"Change in waist-to-hip ratio from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in Body Weight","description":"Change in body weight from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Percent Change in Body Weight","description":"Percent change in baseline body weight at endpoint","timeFrame":"26 Weeks"},{"measure":"Percent of Patients Achieving 5% Weight Loss","description":"Percent of patients who lost at least 5% of baseline body weight at endpoint","timeFrame":"26 weeks"},{"measure":"Percent of Patients Achieving 10% Weight Loss","description":"Percent of patients who lost at least 10% of baseline body weight at endpoint","timeFrame":"26 weeks"},{"measure":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in Fasting Serum Total Cholesterol (TC)","description":"Change in TC from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in High Density Lipoprotein (HDL) Cholesterol","description":"Change in HDL cholesterol from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in TC to HDL Cholesterol Ratio","description":"Change in TC to HDL cholesterol ratio from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in Fasting Serum Triglycerides","description":"Change in fasting serum triglycerides from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in Low Density Lipoprotein (LDL) Cholesterol","description":"Change in LDL cholesterol from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Change in Apolipoprotein-B","description":"Change in apolipoprotein-B from baseline to endpoint","timeFrame":"26 weeks"},{"measure":"Incidence of Hypoglycemic Episodes","description":"Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study","timeFrame":"26 weeks"},{"measure":"Incidence of Nocturnal Hypoglycemic Episodes","description":"Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study","timeFrame":"26 weeks"},{"measure":"Incidence of Severe Hypoglycemic Episodes","description":"Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study","timeFrame":"26 weeks"},{"measure":"Hypoglycemic Rate Per 30 Days","description":"Number of hypoglycemic episodes per patient adjusted per 30 days","timeFrame":"26 weeks"},{"measure":"Nocturnal Hypoglycemic Rate Per 30 Days","description":"Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days","timeFrame":"26 weeks"},{"measure":"Severe Hypoglycemic Rate Per 30 Days","description":"Number of severe hypoglycemic episodes per patient adjusted per 30 days","timeFrame":"26 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes\n* Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.\n* HbA1c between 7.5% and 10.0%.\n* BMI \\>27.\n\nExclusion Criteria:\n\n* Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.\n* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.\n* Treatment with the following medications: \\*Insulin as outpatient therapy within last 3 months; \\*Meglitinides, or acarbose within the last 3 months; \\*Regular use of any drugs that directly affect gastrointestinal motility; \\*Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; \\*Anti-obesity agent use within the last 3 months.\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.","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Mauricio Silva de Lima, MD","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Aberdeen","country":"United Kingdom","geoPoint":{"lat":57.14369,"lon":-2.09814}},{"facility":"Research Site","city":"Bath","country":"United Kingdom","geoPoint":{"lat":51.3751,"lon":-2.36172}},{"facility":"Research Site","city":"Blackburn","country":"United Kingdom","geoPoint":{"lat":53.75,"lon":-2.48333}},{"facility":"Research Site","city":"Bolton","country":"United Kingdom","geoPoint":{"lat":53.58333,"lon":-2.43333}},{"facility":"Research Site","city":"Bournemouth","country":"United Kingdom","geoPoint":{"lat":50.72048,"lon":-1.8795}},{"facility":"Research Site","city":"Bristol","country":"United 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Site","city":"Nottingham","country":"United Kingdom","geoPoint":{"lat":52.9536,"lon":-1.15047}},{"facility":"Research Site","city":"Oldham","country":"United Kingdom","geoPoint":{"lat":53.54051,"lon":-2.1183}},{"facility":"Research Site","city":"Oxford","country":"United Kingdom","geoPoint":{"lat":51.75222,"lon":-1.25596}},{"facility":"Research Site","city":"Plymouth","country":"United Kingdom","geoPoint":{"lat":50.37153,"lon":-4.14305}},{"facility":"Research Site","city":"Rochdale","country":"United Kingdom","geoPoint":{"lat":53.61766,"lon":-2.1552}},{"facility":"Research Site","city":"Salford","country":"United Kingdom","geoPoint":{"lat":53.48771,"lon":-2.29042}},{"facility":"Research Site","city":"Swansea","country":"United Kingdom","geoPoint":{"lat":51.62079,"lon":-3.94323}},{"facility":"Research Site","city":"Torquay","country":"United Kingdom","geoPoint":{"lat":50.46198,"lon":-3.52522}},{"facility":"Research Site","city":"Wakefield","country":"United Kingdom","geoPoint":{"lat":53.68331,"lon":-1.49768}}]},"referencesModule":{"references":[{"pmid":"19930005","type":"RESULT","citation":"Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009 Dec;11(12):1153-62. doi: 10.1111/j.1463-1326.2009.01154.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":{"preAssignmentDetails":"One patient assigned to the Insulin Glargine group withdrew from the study prior to receiving study drug. This patient is not included in the analysis set.","recruitmentDetails":"This study was conducted at 35 study centers in the United Kingdom. Recruitment occurred from June 2006 to October 2007.","groups":[{"id":"FG000","title":"Exenatide","description":"5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks"},{"id":"FG001","title":"Insulin Glargine","description":"dosing based on treat to target protocol"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"118"},{"groupId":"FG001","numSubjects":"117"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","comment":"FAS = received ≥ 1 dose of study drug","numSubjects":"118"},{"groupId":"FG001","comment":"FAS = received ≥ 1 dose of study drug","numSubjects":"116"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","numSubjects":"104"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"13"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Entry criterion not met","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Subject decision","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide","description":"5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks"},{"id":"BG001","title":"Insulin Glargine","description":"dosing based on treat to target 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Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United Kingdom","categories":[{"measurements":[{"groupId":"BG000","value":"118"},{"groupId":"BG001","value":"116"},{"groupId":"BG002","value":"234"}]}]}]},{"title":"Types of oral antidiabetic medication combinations administered at baseline","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"metformin and sulfonylurea","categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"99"}]}]},{"title":"metformin and thiazolidinedione","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"32"}]}]},{"title":"sulfonylurea and thiazolidinedione","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}]}]},{"title":"metformin, sulfonylurea, and thiazolidinedione","categories":[{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"95"}]}]},{"title":"other","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Baseline apolipoprotein-B","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"g/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0.84","spread":"0.24"},{"groupId":"BG001","value":"0.88","spread":"0.24"},{"groupId":"BG002","value":"0.86","spread":"0.24"}]}]}]},{"title":"Baseline fasting serum glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10.84","spread":"2.23"},{"groupId":"BG001","value":"10.12","spread":"2.22"},{"groupId":"BG002","value":"10.48","spread":"2.25"}]}]}]},{"title":"Baseline fasting serum total cholesterol (TC)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.45","spread":"1.05"},{"groupId":"BG001","value":"4.63","spread":"1.20"},{"groupId":"BG002","value":"4.54","spread":"1.13"}]}]}]},{"title":"Baseline fasting serum triglycerides","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.94","spread":"1.01"},{"groupId":"BG001","value":"2.31","spread":"2.24"},{"groupId":"BG002","value":"2.13","spread":"1.75"}]}]}]},{"title":"Baseline high density lipoprotein (HDL) cholesterol","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.14","spread":"0.24"},{"groupId":"BG001","value":"1.15","spread":"0.29"},{"groupId":"BG002","value":"1.15","spread":"0.27"}]}]}]},{"title":"Baseline low density lipoprotein (LDL) cholesterol","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2.38","spread":"0.82"},{"groupId":"BG001","value":"2.49","spread":"1.02"},{"groupId":"BG002","value":"2.43","spread":"0.93"}]}]}]},{"title":"Baseline total cholesterol to high density lipoprotein cholesterol ratio","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"ratio","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.00","spread":"1.10"},{"groupId":"BG001","value":"4.29","spread":"2.15"},{"groupId":"BG002","value":"4.15","spread":"1.72"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)","description":"Composite endpoint evaluating effect of treatment on glycemic control and weight","populationDescription":"Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"26 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks"},{"id":"OG001","title":"Insulin Glargine","description":"dosing based on treat to target protocol"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"116"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53.4"},{"groupId":"OG001","value":"19.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.71","ciPctValue":"95","ciLowerLimit":"2.62","ciUpperLimit":"8.46"}]},{"type":"SECONDARY","title":"Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg","description":"Composite endpoint evaluating effect of treatment on glycemic control and weight","populationDescription":"Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"26 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks"},{"id":"OG001","title":"Insulin Glargine","description":"dosing based on treat to target protocol"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"116"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.5"},{"groupId":"OG001","value":"16.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"5.76","ciPctValue":"95","ciLowerLimit":"3.11","ciUpperLimit":"10.64"}]},{"type":"SECONDARY","title":"Change in Fasting Serum Glucose","description":"Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)","populationDescription":"Full Analysis Set, Last Observation Carried Forward","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"26 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks"},{"id":"OG001","title":"Insulin Glargine","description":"dosing based on treat to target protocol"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"101"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.12","spread":"0.25"},{"groupId":"OG001","value":"-3.61","spread":"0.25"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Percent of Patients Achieving HbA1c ≤ 7.4%","description":"Percent of patients achieving specified HbA1c target at endpoint","populationDescription":"Full Analysis Set, Last Observation Carried Forward. 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