{"protocolSection":{"identificationModule":{"nctId":"NCT00097500","orgStudyIdInfo":{"id":"2993-114"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes","officialTitle":"A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-09"},"primaryCompletionDateStruct":{"date":"2009-12","type":"ACTUAL"},"completionDateStruct":{"date":"2009-12","type":"ACTUAL"},"studyFirstSubmitDate":"2004-11-24","studyFirstSubmitQcDate":"2004-11-24","studyFirstPostDateStruct":{"date":"2004-11-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-12-24","resultsFirstSubmitQcDate":"2010-12-24","resultsFirstPostDateStruct":{"date":"2011-01-10","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 Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["diabetes","exenatide","exendin-4","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":69,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide Arm","type":"EXPERIMENTAL","description":"Exenatide and Metformin","interventionNames":["Drug: exenatide","Drug: Metformin"]},{"label":"Insulin Glargine Arm","type":"ACTIVE_COMPARATOR","description":"Insulin Glargine and Metformin","interventionNames":["Drug: Insulin glargine","Drug: Metformin"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets","armGroupLabels":["Exenatide Arm"],"otherNames":["Byetta"]},{"type":"DRUG","name":"Insulin glargine","description":"subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets","armGroupLabels":["Insulin Glargine Arm"],"otherNames":["Lantus"]},{"type":"DRUG","name":"Metformin","description":"Patients usual dosage","armGroupLabels":["Exenatide Arm","Insulin Glargine Arm"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Beta-cell Function After 52 Weeks of Therapy","description":"Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \\[i.e., clamp time 290 min to 300 min\\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \\[week -2\\]).","timeFrame":"Baseline (week -2) and 52 weeks"}],"secondaryOutcomes":[{"measure":"Beta-cell Function 4 Weeks After Cessation of Therapy","description":"Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \\[i.e., clamp time 290 min to 300 min\\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline \\[week -2\\]).","timeFrame":"Baseline (week -2) and 56 weeks"},{"measure":"Change in First Phase C-peptide Release","description":"Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \\[week -2\\]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.","timeFrame":"baseline (week -2), 52 weeks, and 56 weeks"},{"measure":"Change in Second Phase C-peptide Release","description":"Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \\[week -2\\]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.","timeFrame":"baseline (-2 weeks), 52 weeks, and 56 weeks"},{"measure":"Change in Glycosylated Hemoglobin (HbA1c)","description":"Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).","timeFrame":"Week 0 and week 52"},{"measure":"Change in Fasting Plasma Glucose","description":"Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).","timeFrame":"0 weeks and 52 weeks"},{"measure":"Seven Point Self Monitored Blood Glucose (SMBG) Measurements","description":"SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).","timeFrame":"0 weeks and 52 weeks"},{"measure":"Change in Body Weight","description":"Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).","timeFrame":"0 weeks and 52 weeks"},{"measure":"M-value at Baseline, Week 52 and Week 56","description":"M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.","timeFrame":"baseline (week -2), 52 weeks, and 56 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes, but otherwise healthy\n* HbA1c between 6.6% and 9.5%, inclusive.\n* Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.\n* Treated with a stable dose of metformin for at least 2 months prior to screening.\n\nExclusion Criteria:\n\n* Patients previously in a study using exenatide.\n* Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).\n* Treated with insulin within 3 months of screening.","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Vice President, Research and Development, MD","affiliation":"Amylin Pharmaceuticals, LLC.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Helsinki","country":"Finland","geoPoint":{"lat":60.16952,"lon":24.93545}},{"facility":"Research Site","city":"Amsterdam","country":"Netherlands","geoPoint":{"lat":52.37403,"lon":4.88969}},{"facility":"Research Site","city":"Gothenburg","country":"Sweden","geoPoint":{"lat":57.70716,"lon":11.96679}}]},"referencesModule":{"references":[{"pmid":"19196887","type":"RESULT","citation":"Bunck MC, Diamant M, Corner A, Eliasson B, Malloy JL, Shaginian RM, Deng W, Kendall DM, Taskinen MR, Smith U, Yki-Jarvinen H, Heine RJ. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2009 May;32(5):762-8. doi: 10.2337/dc08-1797. Epub 2009 Feb 5."},{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."},{"pmid":"31078666","type":"DERIVED","citation":"Muskiet MHA, Bunck MC, Heine RJ, Corner A, Yki-Jarvinen H, Eliasson B, Joles JA, Diamant M, Tonneijck L, van Raalte DH. Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial. Diabetes Res Clin Pract. 2019 Jul;153:14-22. doi: 10.1016/j.diabres.2019.05.001. Epub 2019 May 9."},{"pmid":"21868779","type":"DERIVED","citation":"Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Taskinen MR, Smith U, Yki-Jarvinen H, Diamant M. Effects of exenatide on measures of beta-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2041-7. doi: 10.2337/dc11-0291."},{"pmid":"20494360","type":"DERIVED","citation":"Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Wu Y, Yan P, Smith U, Yki-Jarvinen H, Diamant M, Taskinen MR. One-year treatment with exenatide vs. insulin glargine: effects on postprandial glycemia, lipid profiles, and oxidative stress. Atherosclerosis. 2010 Sep;212(1):223-9. doi: 10.1016/j.atherosclerosis.2010.04.024. Epub 2010 Apr 29."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"FG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"periods":[{"title":"On-drug Period (Week 0 to Week 52)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"33"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Subjects experiencing loss of glucose control after Week 52 are considered to have completed study.","numSubjects":"30"},{"groupId":"FG001","comment":"Subjects experiencing loss of glucose control after Week 52 are considered to have completed study.","numSubjects":"30"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Withdrawal of consent","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]},{"title":"Off-drug Period (Week 52 to Week 64)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Exenatide is discontinued, metformin is continued","numSubjects":"30"},{"groupId":"FG001","comment":"Insulin Glargine is discontinued, metformin is continued","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"26"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Withdrawal of consent","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Loss of glucose control","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"BG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"69"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.4","spread":"8.4"},{"groupId":"BG001","value":"58.3","spread":"7.3"},{"groupId":"BG002","value":"58.4","spread":"7.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"24"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"45"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"30.87","spread":"4.15"},{"groupId":"BG001","value":"30.13","spread":"3.49"},{"groupId":"BG002","value":"30.52","spread":"3.84"}]}]}]},{"title":"Body weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"90.56","spread":"12.66"},{"groupId":"BG001","value":"92.39","spread":"13.56"},{"groupId":"BG002","value":"91.44","spread":"13.03"}]}]}]},{"title":"Glycosylated hemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.58","spread":"0.89"},{"groupId":"BG001","value":"7.41","spread":"0.81"},{"groupId":"BG002","value":"7.50","spread":"0.85"}]}]}]},{"title":"Duration of diabetes","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.72","spread":"4.70"},{"groupId":"BG001","value":"3.97","spread":"3.62"},{"groupId":"BG002","value":"4.88","spread":"4.28"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Beta-cell Function After 52 Weeks of Therapy","description":"Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \\[i.e., clamp time 290 min to 300 min\\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \\[week -2\\]).","populationDescription":"Evaluable population","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"Baseline (week -2) and 52 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.89","spread":"0.27"},{"groupId":"OG001","value":"1.15","spread":"0.11"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Beta-cell Function 4 Weeks After Cessation of Therapy","description":"Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \\[i.e., clamp time 290 min to 300 min\\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline \\[week -2\\]).","populationDescription":"Evaluable population","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"Baseline (week -2) and 56 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"0.06"},{"groupId":"OG001","value":"1.08","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4185","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in First Phase C-peptide Release","description":"Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \\[week -2\\]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.","populationDescription":"Evaluable population. Last observation carried forward.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"baseline (week -2), 52 weeks, and 56 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"1.72","spread":"0.11"},{"groupId":"OG001","value":"1.13","spread":"0.07"}]}]},{"title":"56 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"0.05"},{"groupId":"OG001","value":"1.06","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Statistical analysis at week 52.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Statistical analysis at week 56.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1188","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Second Phase C-peptide Release","description":"Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \\[week -2\\]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.","populationDescription":"Evaluable population. Last observation carried forward.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"baseline (-2 weeks), 52 weeks, and 56 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2.88","spread":"0.18"},{"groupId":"OG001","value":"1.01","spread":"0.07"}]}]},{"title":"56 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"0.05"},{"groupId":"OG001","value":"1.08","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Statistical analysis at week 52.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Statistical analysis at week 56.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1996","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Glycosylated Hemoglobin (HbA1c)","description":"Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).","populationDescription":"Intent to treat population. Last observation carried forward.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent","timeFrame":"Week 0 and week 52","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.97","spread":"0.14"},{"groupId":"OG001","value":"-0.87","spread":"0.15"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5522","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose","description":"Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).","populationDescription":"Intent to treat population. Last observation carried forward.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"0 weeks and 52 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.53","spread":"0.25"},{"groupId":"OG001","value":"-3.10","spread":"0.27"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Seven Point Self Monitored Blood Glucose (SMBG) Measurements","description":"SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).","populationDescription":"Intent to treat population.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"0 weeks and 52 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"33"}]}],"classes":[{"title":"Pre-breakfast measurement (week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"8.92","spread":"1.80"},{"groupId":"OG001","value":"8.38","spread":"1.91"}]}]},{"title":"Pre-breakfast measurement (week 52)","categories":[{"measurements":[{"groupId":"OG000","value":"7.27","spread":"1.63"},{"groupId":"OG001","value":"5.63","spread":"0.85"}]}]},{"title":"2-hour post-breakfast measurement (week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"11.00","spread":"2.58"},{"groupId":"OG001","value":"11.17","spread":"3.30"}]}]},{"title":"2-hour post-breakfast measurement (week 52)","categories":[{"measurements":[{"groupId":"OG000","value":"6.98","spread":"2.42"},{"groupId":"OG001","value":"7.53","spread":"2.16"}]}]},{"title":"Pre-lunch measurement (week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"8.14","spread":"2.25"},{"groupId":"OG001","value":"8.54","spread":"2.51"}]}]},{"title":"Pre-lunch measurement (week 52)","categories":[{"measurements":[{"groupId":"OG000","value":"6.52","spread":"1.52"},{"groupId":"OG001","value":"6.24","spread":"1.66"}]}]},{"title":"2-hour post-lunch measurement (week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"9.90","spread":"2.54"},{"groupId":"OG001","value":"10.52","spread":"2.96"}]}]},{"title":"2-hour post-lunch measurement (week 52)","categories":[{"measurements":[{"groupId":"OG000","value":"7.97","spread":"2.01"},{"groupId":"OG001","value":"8.15","spread":"1.77"}]}]},{"title":"Pre-dinner measurement (week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"8.38","spread":"2.40"},{"groupId":"OG001","value":"8.07","spread":"2.48"}]}]},{"title":"Pre-dinner measurement (week 52)","categories":[{"measurements":[{"groupId":"OG000","value":"7.53","spread":"2.63"},{"groupId":"OG001","value":"6.98","spread":"2.04"}]}]},{"title":"2-hour post-dinner measurement (week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"10.42","spread":"2.42"},{"groupId":"OG001","value":"10.26","spread":"2.82"}]}]},{"title":"2-hour post-dinner measurement (week 52)","categories":[{"measurements":[{"groupId":"OG000","value":"6.98","spread":"2.25"},{"groupId":"OG001","value":"8.81","spread":"2.03"}]}]},{"title":"Bedtime measurement (week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"9.76","spread":"2.44"},{"groupId":"OG001","value":"9.85","spread":"3.09"}]}]},{"title":"Bedtime measurement (week 52)","categories":[{"measurements":[{"groupId":"OG000","value":"7.61","spread":"2.11"},{"groupId":"OG001","value":"8.03","spread":"2.82"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).","populationDescription":"Intent to treat population. Last observation carried forward.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"0 weeks and 52 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.80","spread":"0.87"},{"groupId":"OG001","value":"0.75","spread":"0.95"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"M-value at Baseline, Week 52 and Week 56","description":"M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.","populationDescription":"Evaluable population.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/min/kg","timeFrame":"baseline (week -2), 52 weeks, and 56 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability."},{"id":"OG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"baseline (week -2)","categories":[{"measurements":[{"groupId":"OG000","value":"2.24","spread":"0.39"},{"groupId":"OG001","value":"2.79","spread":"0.26"}]}]},{"title":"week 52","categories":[{"measurements":[{"groupId":"OG000","value":"3.18","spread":"0.42"},{"groupId":"OG001","value":"3.85","spread":"0.32"}]}]},{"title":"week 56","categories":[{"measurements":[{"groupId":"OG000","value":"3.19","spread":"0.44"},{"groupId":"OG001","value":"2.81","spread":"0.29"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.","eventGroups":[{"id":"EG000","title":"Exenatide Arm","description":"5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.","seriousNumAffected":3,"seriousNumAtRisk":36,"otherNumAffected":32,"otherNumAtRisk":36},{"id":"EG001","title":"Insulin Glargine Arm","description":"Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.","seriousNumAffected":1,"seriousNumAtRisk":33,"otherNumAffected":31,"otherNumAtRisk":33}],"seriousEvents":[{"term":"Coronary Artery Stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Diverticulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Thrombophlebitis Superficial","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":33}]}],"otherEvents":[{"term":"Anemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":33}]},{"term":"Abdominal Distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":33}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":33}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Injection Site Rash","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Edema Peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":33}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":33}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":36},{"groupId":"EG001","numAffected":9,"numAtRisk":33}]},{"term":"Laryngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":33}]},{"term":"Tooth Infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":33}]},{"term":"Urinary Tract Infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":33}]},{"term":"Decreased Appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Hyperlipidemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":33}]},{"term":"Hypoglycemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":36},{"groupId":"EG001","numAffected":10,"numAtRisk":33}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":33}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":33}]},{"term":"Proteinuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":33}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":33}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Peter Ohman, Medical Science Director","organization":"AstraZeneca","email":"ClinicalTrialTransparency@astrazeneca.com"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D003920","term":"Diabetes Mellitus"}],"ancestors":[{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"},{"id":"D000069036","term":"Insulin Glargine"},{"id":"D008687","term":"Metformin"}],"ancestors":[{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D014688","term":"Venoms"},{"id":"D045424","term":"Complex Mixtures"},{"id":"D014118","term":"Toxins, Biological"},{"id":"D001685","term":"Biological Factors"},{"id":"D049528","term":"Insulin, Long-Acting"},{"id":"D061385","term":"Insulins"},{"id":"D010187","term":"Pancreatic Hormones"},{"id":"D036361","term":"Peptide Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"},{"id":"D001645","term":"Biguanides"},{"id":"D006146","term":"Guanidines"},{"id":"D000578","term":"Amidines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}