{"protocolSection":{"identificationModule":{"nctId":"NCT00375492","orgStudyIdInfo":{"id":"H8O-US-GWBM"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Effect on Weight Loss of Exenatide Versus Placebo","officialTitle":"Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-09"},"primaryCompletionDateStruct":{"date":"2008-02","type":"ACTUAL"},"completionDateStruct":{"date":"2008-02","type":"ACTUAL"},"studyFirstSubmitDate":"2006-09-11","studyFirstSubmitQcDate":"2006-09-11","studyFirstPostDateStruct":{"date":"2006-09-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-02-25","resultsFirstSubmitQcDate":"2009-07-30","resultsFirstPostDateStruct":{"date":"2009-09-04","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 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["diabetes","overweight","obesity","weight loss","exenatide","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":196,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Group A","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide"]},{"label":"Group B","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"subcutaneous injection, 5mcg or 10mcg, twice a day","armGroupLabels":["Group A"],"otherNames":["Byetta"]},{"type":"DRUG","name":"placebo","description":"subcutaneous injection, volume equivalent to exenatide dose, twice a day","armGroupLabels":["Group B"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Body Weight","description":"Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).","timeFrame":"Baseline, Week 24"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24","description":"Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.","timeFrame":"baseline, Week 24"},{"measure":"Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24","description":"Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).","timeFrame":"baseline, Week 24"},{"measure":"Change From Baseline in Waist Circumference at Week 24","description":"Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).","timeFrame":"baseline, Week 24"},{"measure":"Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline","description":"Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.","timeFrame":"baseline, Week 24"},{"measure":"Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline","description":"Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.","timeFrame":"baseline, Week 24"},{"measure":"Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24","description":"Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.","timeFrame":"baseline, Week 24"},{"measure":"Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24","description":"Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L","timeFrame":"baseline, Week 24"},{"measure":"Change From Baseline in Total Cholesterol at Week 24","description":"Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.","timeFrame":"baseline, week 24"},{"measure":"Ratio of Triglycerides at Week 24 to Triglycerides at Baseline","description":"Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.","timeFrame":"baseline, Week 24"},{"measure":"Number of Participants With Hypoglycemic Events During the Study","description":"Number of participants experiencing one or more events of hypoglycemia at any point in the study","timeFrame":"Baseline to 24 weeks"},{"measure":"Rate of Hypoglycemic Events","description":"Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).","timeFrame":"24 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes for at least 6 months\n* Have been treated with a stable dose of the following for at least 6 weeks prior to screening: \\*immediate or extended release metformin, or \\*a sulfonylurea, or \\*a fixed-dose sulfonylurea/metformin combination therapy\n* Have an HbA1c of 6.6% to 10.0%, inclusive\n* Have a Body Mass Index (BMI) of 25 kg/m\\^2 to 39.9 kg/m\\^2, inclusive\n\nExclusion Criteria:\n\n* Are treated with any of the following excluded medications: \\*exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; \\*Symlin injection at any time; \\* Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; \\*drugs that directly affect gastrointestinal motility; \\*use of a weight loss drug (including those available over the counter) within 3 months of screening; \\*chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening\n* Have conditions contraindicating metformin and/or sulfonylurea use\n* Have had a change in lipid-lowering agents within 6 weeks of screening\n* Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in this study\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":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"James Malone, MD","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Peoria","state":"Arizona","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"Research Site","city":"Jacksonville","state":"Florida","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Research Site","city":"Orlando","state":"Florida","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Research Site","city":"Indianapolis","state":"Indiana","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Research Site","city":"Boston","state":"Massachusetts","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Research Site","city":"Minneapolis","state":"Minnesota","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"Research Site","city":"St Louis","state":"Missouri","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Research Site","city":"Spartanburg","state":"South Carolina","country":"United States","geoPoint":{"lat":34.94957,"lon":-81.93205}},{"facility":"Research Site","city":"San Antonio","state":"Texas","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Research Site","city":"Renton","state":"Washington","country":"United States","geoPoint":{"lat":47.48288,"lon":-122.21707}}]},"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."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"One randomized patient per group discontinued before receiving study drug. These patients are not included in the \"started\" category below.","groups":[{"id":"FG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks"},{"id":"FG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"98"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"70"},{"groupId":"FG001","numSubjects":"72"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Entry Criteria Not Met","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Loss of Glucose Control","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks"},{"id":"BG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"96"},{"groupId":"BG001","value":"98"},{"groupId":"BG002","value":"194"}]}],"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":"78"},{"groupId":"BG001","value":"82"},{"groupId":"BG002","value":"160"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"34"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.52","spread":"10.02"},{"groupId":"BG001","value":"55.08","spread":"8.97"},{"groupId":"BG002","value":"54.81","spread":"9.48"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"60"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"121"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"73"}]}]}]},{"title":"Baseline Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"94.90","spread":"16.52"},{"groupId":"BG001","value":"96.16","spread":"16.53"},{"groupId":"BG002","value":"95.53","spread":"16.05"}]}]}]},{"title":"Baseline Cholesterol","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.67","spread":"1.03"},{"groupId":"BG001","value":"4.68","spread":"0.90"},{"groupId":"BG002","value":"4.68","spread":"0.96"}]}]}]},{"title":"Baseline Glycosylated Hemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percent hemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.74","spread":"0.87"},{"groupId":"BG001","value":"7.51","spread":"0.82"},{"groupId":"BG002","value":"7.62","spread":"0.85"}]}]}]},{"title":"Baseline High Density Lipoprotein (HDL) Cholesterol","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.18","spread":"0.32"},{"groupId":"BG001","value":"1.21","spread":"0.31"},{"groupId":"BG002","value":"1.20","spread":"0.31"}]}]}]},{"title":"Baseline Homeostatic Model Assessment-Beta Cell (HOMA-B)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percent beta-cell function","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"75.15","spread":"81.20"},{"groupId":"BG001","value":"70.72","spread":"53.16"},{"groupId":"BG002","value":"72.81","spread":"67.65"}]}]}]},{"title":"Baseline Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percent insulin sensitivity","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"49.72","spread":"32.12"},{"groupId":"BG001","value":"62.90","spread":"41.07"},{"groupId":"BG002","value":"56.68","spread":"37.57"}]}]}]},{"title":"Baseline Low Density Lipoprotein (LDL) Cholesterol","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2.74","spread":"0.88"},{"groupId":"BG001","value":"2.78","spread":"0.82"},{"groupId":"BG002","value":"2.76","spread":"0.85"}]}]}]},{"title":"Baseline Triglycerides","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2.15","spread":"0.94"},{"groupId":"BG001","value":"2.13","spread":"1.00"},{"groupId":"BG002","value":"2.14","spread":"0.97"}]}]}]},{"title":"Baseline Waist Circumference","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"109.64","spread":"11.12"},{"groupId":"BG001","value":"108.85","spread":"12.10"},{"groupId":"BG002","value":"109.24","spread":"11.60"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Body Weight","description":"Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).","populationDescription":"Intent to Treat population","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks"},{"id":"OG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"72"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.16","spread":"0.54"},{"groupId":"OG001","value":"-3.97","spread":"0.52"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0030","statisticalMethod":"Mixed Model Repeated Measures","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24","description":"Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.","populationDescription":"Intent to Treat population","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent hemoglobin","timeFrame":"baseline, Week 24","groups":[{"id":"OG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks"},{"id":"OG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"71"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.21","spread":"0.09"},{"groupId":"OG001","value":"-0.73","spread":"0.09"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Mixed Model Repeated Measures","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24","description":"Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).","populationDescription":"Intent to Treat population","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"baseline, Week 24","groups":[{"id":"OG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks"},{"id":"OG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Morning Pre-Meal","categories":[{"measurements":[{"groupId":"OG000","value":"-1.87","spread":"0.17"},{"groupId":"OG001","value":"-1.20","spread":"0.17"}]}]},{"title":"2 Hours Post Morning Meal","categories":[{"measurements":[{"groupId":"OG000","value":"-2.67","spread":"0.22"},{"groupId":"OG001","value":"-1.92","spread":"0.22"}]}]},{"title":"Midday Pre-Meal","categories":[{"measurements":[{"groupId":"OG000","value":"-1.40","spread":"0.19"},{"groupId":"OG001","value":"-1.37","spread":"0.19"}]}]},{"title":"2 Hours Post Midday Meal","categories":[{"measurements":[{"groupId":"OG000","value":"-2.12","spread":"0.21"},{"groupId":"OG001","value":"-1.51","spread":"0.20"}]}]},{"title":"Evening Pre-Meal","categories":[{"measurements":[{"groupId":"OG000","value":"-1.57","spread":"0.19"},{"groupId":"OG001","value":"-1.32","spread":"0.19"}]}]},{"title":"2 Hours Post Evening Meal","categories":[{"measurements":[{"groupId":"OG000","value":"-3.09","spread":"0.22"},{"groupId":"OG001","value":"-2.28","spread":"0.23"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference at Week 24","description":"Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).","populationDescription":"Intent to Treat population","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"cm","timeFrame":"baseline, Week 24","groups":[{"id":"OG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks"},{"id":"OG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"69"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.33","spread":"0.71"},{"groupId":"OG001","value":"-4.18","spread":"0.73"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1985","statisticalMethod":"Mixed Model Repeated Measures","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline","description":"Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.","populationDescription":"Intent to Treat population","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Ratio","timeFrame":"baseline, Week 24","groups":[{"id":"OG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks"},{"id":"OG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"76"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.46","spread":"0.12"},{"groupId":"OG001","value":"1.29","spread":"0.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1827","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline","description":"Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.","populationDescription":"Intent to Treat population","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Ratio","timeFrame":"baseline, Week 24","groups":[{"id":"OG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks"},{"id":"OG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"76"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.08","spread":"0.07"},{"groupId":"OG001","value":"0.97","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1584","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24","description":"Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). 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