{"protocolSection":{"identificationModule":{"nctId":"NCT00765817","orgStudyIdInfo":{"id":"H8O-US-GWCO"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus","officialTitle":"A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications"},"statusModule":{"statusVerifiedDate":"2016-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-10"},"primaryCompletionDateStruct":{"date":"2010-01","type":"ACTUAL"},"completionDateStruct":{"date":"2010-01","type":"ACTUAL"},"studyFirstSubmitDate":"2008-10-01","studyFirstSubmitQcDate":"2008-10-01","studyFirstPostDateStruct":{"date":"2008-10-03","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-01-04","resultsFirstSubmitQcDate":"2011-01-04","resultsFirstPostDateStruct":{"date":"2011-01-26","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-10-21","lastUpdatePostDateStruct":{"date":"2016-10-24","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["diabetes","exenatide","Amylin","Lilly","metformin","pioglitazone","insulin glargine"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":261,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]},{"label":"2","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide"]}],"interventions":[{"type":"DRUG","name":"placebo","description":"subcutaneous injection, twice a day","armGroupLabels":["1"]},{"type":"DRUG","name":"exenatide","description":"subcutaneous injection, twice a day, 10mcg","armGroupLabels":["2"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycosylated Hemoglobin (HbA1c)","description":"Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.","timeFrame":"baseline and 30 weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Patients Achieving HbA1c <=7%","description":"Percentage of patients in each arm who had HbA1c \\>7% at baseline and had HbA1c \\<=7% at week 30 (percentage = \\[number of subjects with HbA1c \\<=7% at week 30 divided by number of subjects with HbA1c \\>7% at baseline\\] \\* 100%).","timeFrame":"baseline and 30 weeks"},{"measure":"Percentage of Patients Achieving HbA1c <=6.5%","description":"Percentage of patients in each arm who had HbA1c \\>6.5% at baseline and had HbA1c \\<=6.5% at week 30 (percentage = \\[number of subjects with HbA1c \\<=6.5% at week 30 divided by number of subjects with HbA1c \\>6.5% at baseline\\] \\* 100%).","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Fasting Serum Glucose","description":"Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in 7-point Self-monitored Blood Glucose (SMBG) Profile","description":"Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Total Cholesterol","description":"Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Low Density Lipoprotein (LDL) Cholesterol","description":"Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in High Density Lipoprotein (HDL) Cholesterol","description":"Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Triglycerides","description":"Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Body Weight","description":"Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Daily Insulin Dose","description":"Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Daily Insulin Dose (on a Per Body Weight Basis)","description":"Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Systolic Blood Pressure (SBP)","description":"Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Change in Diastolic Blood Pressure (DBP)","description":"Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)","timeFrame":"baseline and 30 weeks"},{"measure":"Minor Hypoglycemia Rate Per Year","description":"Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \\<3.0 mmol/L (54 mg/dL).","timeFrame":"baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30"},{"measure":"Percentage of Subjects Experiencing Minor Hypoglycemia","description":"Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \\<3.0 mmol/L (54 mg/dL).","timeFrame":"baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have type 2 diabetes.\n* Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.\n\nHave been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:\n\n1. metformin (stable dose for 6 weeks)\n2. pioglitazone (stable dose for 6 weeks)\n3. a combination of metformin and pioglitazone (stable dose for 6 weeks)\n\n   * Have HbA1C between 7.1% and 10.5%, inclusive.\n   * Have a body mass index (BMI) ≤45 kg/m2.\n   * Have a history of stable body weight (not varying by \\>5% for at least 3 months prior to screening).\n\nExclusion Criteria:\n\n* Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.\n* Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.\n* Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.\n* Women who are breastfeeding.\n* Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.\n* Have had a kidney transplant or are currently on kidney dialysis.\n* Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.\n* Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.\n* Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.\n* Are currently on a weight-loss program or have been on one within 3 months of entering the study.\n* Have had a blood transfusion or severe blood loss within 3 months of entering the study.\n* Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.\n* Have an irregular sleep cycle (for example, sleeping during the day and working during the night).\n* Have a history of pancreatitis.\n* Have received treatment with an experimental drug within 30 days of entering the study.\n* If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.\n* If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.\n* If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","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":"Phoenix","state":"Arizona","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Research Site","city":"Buena Park","state":"California","country":"United 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Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18."},{"pmid":"23043166","type":"DERIVED","citation":"Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5."},{"pmid":"22913891","type":"DERIVED","citation":"Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567."},{"pmid":"22432107","type":"DERIVED","citation":"Rosenstock J, Shenouda SK, Bergenstal RM, Buse JB, Glass LC, Heilmann CR, Kwan AY, MacConell LA, Hoogwerf BJ. Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes. Diabetes Care. 2012 May;35(5):955-8. doi: 10.2337/dc11-1434. Epub 2012 Mar 19."},{"pmid":"21138825","type":"DERIVED","citation":"Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011 Jan 18;154(2):103-12. doi: 10.7326/0003-4819-154-2-201101180-00300. Epub 2010 Dec 6."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Two subjects who started the study, subsequently withdrew prior to receiving study medication and are not part of the full analysis set","groups":[{"id":"FG000","title":"Exenatide Arm","description":"Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)"},{"id":"FG001","title":"Placebo Arm","description":"Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"One subject withdrew prior to receiving study medication, not included in analysis set","numSubjects":"138"},{"groupId":"FG001","comment":"One subject withdrew prior to receiving study medication, not included in analysis set","numSubjects":"123"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"112"},{"groupId":"FG001","numSubjects":"101"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"22"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Entry criteria not met","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Loss of glucose control","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Subject decision","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"11"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"One subject per group withdrew from the study prior to the first dose of study medication and therefore are not part of the baseline or subsequent analysis.","groups":[{"id":"BG000","title":"Exenatide Arm","description":"Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)"},{"id":"BG001","title":"Placebo Arm","description":"Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"137"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"259"}]}],"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":"100"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"184"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"75"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.67","spread":"8.91"},{"groupId":"BG001","value":"59.40","spread":"9.96"},{"groupId":"BG002","value":"59.01","spread":"9.41"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"67"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"111"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"148"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Glycosylated Hemoglobin (HbA1c)","description":"Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.","populationDescription":"Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of hemoglobin","timeFrame":"baseline and 30 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)"},{"id":"OG001","title":"Placebo Arm","description":"Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"100"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.71","spread":"0.09"},{"groupId":"OG001","value":"-1.00","spread":"0.09"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving HbA1c <=7%","description":"Percentage of patients in each arm who had HbA1c \\>7% at baseline and had HbA1c \\<=7% at week 30 (percentage = \\[number of subjects with HbA1c \\<=7% at week 30 divided by number of subjects with HbA1c \\>7% at baseline\\] \\* 100%).","populationDescription":"Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c \\> target were included in calculation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage","timeFrame":"baseline and 30 weeks","groups":[{"id":"OG000","title":"Exenatide Arm","description":"Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)"},{"id":"OG001","title":"Placebo Arm","description":"Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58.3"},{"groupId":"OG001","value":"31.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving HbA1c <=6.5%","description":"Percentage of patients in each arm who had HbA1c \\>6.5% at baseline and had HbA1c \\<=6.5% at week 30 (percentage = \\[number of subjects with HbA1c \\<=6.5% at week 30 divided by number of subjects with HbA1c \\>6.5% at baseline\\] \\* 100%).","populationDescription":"Full analysis set. 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