{"protocolSection":{"identificationModule":{"nctId":"NCT00308139","orgStudyIdInfo":{"id":"2993LAR-105 (DURATION - 1)"},"secondaryIdInfos":[{"id":"MB001-010","type":"OTHER","domain":"Bristol Myers Squibb"}],"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)","officialTitle":"A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications"},"statusModule":{"statusVerifiedDate":"2015-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-04"},"primaryCompletionDateStruct":{"date":"2008-07","type":"ACTUAL"},"completionDateStruct":{"date":"2014-08","type":"ACTUAL"},"studyFirstSubmitDate":"2006-03-27","studyFirstSubmitQcDate":"2006-03-27","studyFirstPostDateStruct":{"date":"2006-03-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-02-14","resultsFirstSubmitQcDate":"2012-07-12","resultsFirstPostDateStruct":{"date":"2012-08-17","type":"ESTIMATED"},"dispFirstSubmitDate":"2011-06-17","dispFirstSubmitQcDate":"2011-06-17","dispFirstPostDateStruct":{"date":"2011-06-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-07-29","lastUpdatePostDateStruct":{"date":"2015-08-26","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.","detailedDescription":"This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. The study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly. Long-term safety and efficacy will be monitored during the open-ended assessment periods. This study will be conducted in approximately 300 subjects with type 2 diabetes treated with diet modification and exercise alone or in combination with a stable regimen of metformin, SU, thiazolidinedione (TZD), a combination of metformin and SU, a combination of metformin and TZD, or a combination of SU and TZD."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["diabetes","exenatide","long acting release","LAR","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":303,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide Once Weekly","type":"EXPERIMENTAL","description":"Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide.","interventionNames":["Drug: exenatide, long acting release"]},{"label":"Exenatide Twice Daily","type":"ACTIVE_COMPARATOR","description":"subcutaneous injection (SC), twice a day for the first 30 weeks, followed by exenatide LAR SC injection weekly for the remainder of the study.\n\nSub-study: Exenatide 2 mg subcutaneous injection, Administered Using the Exenatide Once Weekly Single-Dose Tray , once a week for 11 visits, switch to Exenatide 2 mg subcutaneous injection, Administered Using the Dual chamber pen device. Exenatide 2mg SC injection administered using the Dual chamber pen device.","interventionNames":["Drug: exenatide"]}],"interventions":[{"type":"DRUG","name":"exenatide, long acting release","armGroupLabels":["Exenatide Once Weekly"],"otherNames":["BYDUREON"]},{"type":"DRUG","name":"exenatide","armGroupLabels":["Exenatide Twice Daily"],"otherNames":["Byetta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c From Baseline to Week 30","description":"Absolute change in HbA1c from Baseline (Day -3) to Week 30 \\[Week 30 - Baseline\\]","timeFrame":"Day -3, Week 30"},{"measure":"Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)","description":"Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval","timeFrame":"Week 22"}],"secondaryOutcomes":[{"measure":"Change in HbA1c From Baseline to Week 364","description":"Absolute change in HbA1c from Baseline (Day -3) to Week 364","timeFrame":"Day -3, Week 364"},{"measure":"Percentage of Subjects Achieving HbA1c Target of <7%","description":"Percentage of subjects achieving HbA1c target value of \\<7% at Week 30.","timeFrame":"Week 30"},{"measure":"Percentage of Subjects Achieving HbA1c Target of <7%","description":"Percentages of subjects achieving HbA1c target value of \\<7% at Week 364","timeFrame":"Week 364"},{"measure":"Percentage of Subjects Achieving HbA1c Target of <=6.5%","description":"Percentages of subjects achieving HbA1c target values of \\<=6.5% at Week 30.","timeFrame":"Week 30"},{"measure":"Percentage of Subjects Achieving HbA1c Target of <=6.5%","description":"Percentages of subjects achieving HbA1c target values of \\<=6.5% at Week 364","timeFrame":"Week 364"},{"measure":"Percentage of Subjects Achieving HbA1c Target of <=6.0%","description":"Percentage of subjects achieving HbA1c target values of \\<=6.0% at Week 30.","timeFrame":"Week 30"},{"measure":"Exenatide LAR Steady State Concentration From Week 29 to Week 30","description":"Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.","timeFrame":"Week 29 to Week 30"},{"measure":"Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14","description":"Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14","timeFrame":"Day -3, Week 14"},{"measure":"Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)","description":"Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.","timeFrame":"Week 22"},{"measure":"Change in Body Weight From Baseline to Week 30","description":"Change in body weight from baseline (Day -3) to Week 30","timeFrame":"Day -3, Week 30"},{"measure":"Change in Body Weight From Baseline to Week 364","description":"Change in body weight from baseline (Day -3) to Week 364","timeFrame":"Day -3, Week 364"},{"measure":"Change in Fasting Plasma Glucose From Baseline to Week 30","description":"Change in fasting plasma glucose from baseline (Day -3) to Week 30.","timeFrame":"Day -3, Week 30"},{"measure":"Change in Fasting Plasma Glucose From Baseline to Week 364","description":"Change in fasting plasma glucose from baseline (Day -3) to Week 364.","timeFrame":"Day -3, Week 364"},{"measure":"Change in Blood Pressure From Baseline to Week 30","description":"Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30","timeFrame":"Day -3, Week 30"},{"measure":"Change in Blood Pressure From Baseline to Week 364","description":"Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364","timeFrame":"Day -3, Week 364"},{"measure":"Change in Total Cholesterol From Baseline to Week 30","description":"Change in total cholesterol from baseline (Day -3) to Week 30.","timeFrame":"Day -3, Week 30"},{"measure":"Change in Total Cholesterol From Baseline to Week 364","description":"Change in total cholesterol from baseline (Day -3) to Week 364.","timeFrame":"Day -3, Week 364"},{"measure":"Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30","description":"Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.","timeFrame":"Day -3, Week 30"},{"measure":"Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364","description":"Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.","timeFrame":"Day -3, Week 364"},{"measure":"Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364","description":"Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.","timeFrame":"Day -3, Week 364"},{"measure":"Ratio of Triglycerides at Week 30 to Baseline","description":"Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.","timeFrame":"Day -3, Week 30"},{"measure":"Ratio of Triglycerides at Week 364 to Baseline","description":"Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.","timeFrame":"Day -3, Week 364"},{"measure":"Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening","description":"The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.","timeFrame":"Day 1 to Week 364"},{"measure":"Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening","description":"The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.","timeFrame":"Day 1 to Week 364"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.\n* Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.\n* Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.\n* (For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105\n\nExclusion Criteria:\n\n* Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.\n* Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.\n* Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:\n\n  * Alpha glucosidase inhibitor or meglitinide within 30 days of screening;\n  * Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;\n  * Regular use (\\> 14 days) of drugs that directly affect gastrointestinal motility;\n  * Regular use (\\> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;\n  * Regular use (\\> 14 days) of medications with addictive potential such as opiates and opioids;\n  * Prescription or over-the-counter weight loss medications within 6 months of screening.\n* (For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy","healthyVolunteers":false,"sex":"ALL","minimumAge":"16 Years","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Lisa Porter, MD","affiliation":"Amylin Pharmaceuticals, LLC.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site 182","city":"Encino","state":"California","zip":"91436","country":"United States","geoPoint":{"lat":34.15917,"lon":-118.50119}},{"facility":"Research Site 171","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"Research Site 518","city":"San Diego","state":"California","zip":"92161","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Research Site 024","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Research Site","city":"Colorado Springs","state":"Colorado","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Research Site 057","city":"Miami","state":"Florida","zip":"33156","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Research Site","city":"Chicago","state":"Illinois","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Research Site 149","city":"Indianapolis","state":"Indiana","zip":"46254","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Research Site 099","city":"Lexington","state":"Kentucky","zip":"40503","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"Research Site 017","city":"Detroit","state":"Michigan","zip":"48202","country":"United States","geoPoint":{"lat":42.33143,"lon":-83.04575}},{"facility":"Research Site 224","city":"Minneapolis","state":"Minnesota","zip":"55416","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"Research Site 312","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Research Site 023","city":"Butte","state":"Montana","zip":"59701","country":"United States","geoPoint":{"lat":46.00382,"lon":-112.53474}},{"facility":"Research Site 053","city":"Rochester","state":"New York","zip":"14609","country":"United States","geoPoint":{"lat":43.15478,"lon":-77.61556}},{"facility":"Research Site 002","city":"Durham","state":"North Carolina","zip":"27713","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}},{"facility":"Research Site 123","city":"Winston-Salem","state":"North Carolina","zip":"27103","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}},{"facility":"Research Site 405","city":"Cincinnati","state":"Ohio","zip":"45219","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Research Site 557","city":"Marion","state":"Ohio","zip":"43302","country":"United States","geoPoint":{"lat":40.58867,"lon":-83.12852}},{"facility":"Research Site 231","city":"Portland","state":"Oregon","zip":"97239","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Research Site 152","city":"Philadelphia","state":"Pennsylvania","zip":"19146","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Research Site 587","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"Research Site 015","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Research Site 009","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Research Site 108","city":"Olympia","state":"Washington","zip":"98502","country":"United States","geoPoint":{"lat":47.04491,"lon":-122.90169}},{"facility":"Research Site","city":"Toronto","state":"Ontario","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}}]},"referencesModule":{"references":[{"pmid":"30600137","type":"DERIVED","citation":"Philis-Tsimikas A, Wysham CH, Hardy E, Han J, Iqbal N. Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study. J Diabetes Complications. 2019 Mar;33(3):223-230. doi: 10.1016/j.jdiacomp.2018.11.012. Epub 2018 Dec 5."},{"pmid":"27525540","type":"DERIVED","citation":"Henry RR, Klein EJ, Han J, Iqbal N. Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study. Diabetes Technol Ther. 2016 Nov;18(11):677-686. doi: 10.1089/dia.2016.0107. Epub 2016 Aug 15."},{"pmid":"25744115","type":"DERIVED","citation":"Wysham CH, MacConell LA, Maggs DG, Zhou M, Griffin PS, Trautmann ME. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015 Mar;90(3):356-65. doi: 10.1016/j.mayocp.2015.01.008."},{"pmid":"23748506","type":"DERIVED","citation":"Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660."},{"pmid":"23358123","type":"DERIVED","citation":"Macconell L, Pencek R, Li Y, Maggs D, Porter L. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31-41. doi: 10.2147/DMSO.S35801. Epub 2013 Jan 21."},{"pmid":"23166441","type":"DERIVED","citation":"Chiquette E, Toth PP, Ramirez G, Cobble M, Chilton R. Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers. Vasc Health Risk Manag. 2012;8:621-9. doi: 10.2147/VHRM.S37969. Epub 2012 Nov 12."},{"pmid":"22236356","type":"DERIVED","citation":"Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10."},{"pmid":"21529363","type":"DERIVED","citation":"Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocr Disord. 2011 Apr 29;11:9. doi: 10.1186/1472-6823-11-9."},{"pmid":"20215461","type":"DERIVED","citation":"Buse JB, Drucker DJ, Taylor KL, Kim T, Walsh B, Hu H, Wilhelm K, Trautmann M, Shen LZ, Porter LE; DURATION-1 Study Group. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010 Jun;33(6):1255-61. doi: 10.2337/dc09-1914. Epub 2010 Mar 9."},{"pmid":"18782641","type":"DERIVED","citation":"Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008 Oct 4;372(9645):1240-50. doi: 10.1016/S0140-6736(08)61206-4. Epub 2008 Sep 7."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"FG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"152"},{"groupId":"FG001","numSubjects":"151"}]},{"type":"Intent to Treat (ITT)","achievements":[{"groupId":"FG000","comment":"Subjects who received at least one injection of lead-in exenatide 5 mcg.","numSubjects":"148"},{"groupId":"FG001","comment":"Subjects who received at least one injection of lead-in exenatide 5 mcg.","numSubjects":"147"}]},{"type":"ITT in the 30-Week Assessment","achievements":[{"groupId":"FG000","comment":"ITT Subjects who received at least one injection of randomized dose.","numSubjects":"148"},{"groupId":"FG001","comment":"ITT Subjects who received at least one injection of randomized dose.","numSubjects":"145"}]},{"type":"Pharmacokinetics Population","achievements":[{"groupId":"FG000","numSubjects":"129"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Evaluable Meal Tolerance Cohort","achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"30-Week Completed","achievements":[{"groupId":"FG000","comment":"Subjects who completed 30 weeks of assessment","numSubjects":"128"},{"groupId":"FG001","comment":"Subjects who completed 30 weeks of assessment","numSubjects":"130"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Subjects who completed 364 weeks of assessment","numSubjects":"58"},{"groupId":"FG001","comment":"Subjects who completed 364 weeks of assessment","numSubjects":"64"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"94"},{"groupId":"FG001","numSubjects":"87"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"14"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"42"}]},{"type":"Investigator Decision","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"Loss of Glucose Control","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Administrative","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"BG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"148"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"295"}]}],"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":"122"},{"groupId":"BG001","value":"123"},{"groupId":"BG002","value":"245"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"50"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.2","spread":"9.72"},{"groupId":"BG001","value":"54.9","spread":"9.63"},{"groupId":"BG002","value":"55.0","spread":"9.66"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"138"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"75"},{"groupId":"BG002","value":"157"}]}]}]},{"title":"Glycosylated hemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of total hemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.3","spread":"0.99"},{"groupId":"BG001","value":"8.3","spread":"1.00"},{"groupId":"BG002","value":"8.3","spread":"0.99"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"101.7","spread":"18.76"},{"groupId":"BG001","value":"101.9","spread":"21.05"},{"groupId":"BG002","value":"101.8","spread":"19.90"}]}]}]},{"title":"Background Oral Antidiabetic Agent","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Diet and Exercise","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"43"}]}]},{"title":"Metformin (MET)","categories":[{"measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"106"}]}]},{"title":"Sulfonylurea (SU)","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"16"}]}]},{"title":"Thiazolidinediones (TZD)","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"9"}]}]},{"title":"MET+SU","categories":[{"measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"82"}]}]},{"title":"MET+TZD","categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"28"}]}]},{"title":"SU+TZD","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"}]}]},{"title":"SU+MET+TZD","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c From Baseline to Week 30","description":"Absolute change in HbA1c from Baseline (Day -3) to Week 30 \\[Week 30 - Baseline\\]","populationDescription":"The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 30 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of total hemoglobin","timeFrame":"Day -3, Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.87","spread":"0.082","lowerLimit":"-2.03","upperLimit":"-1.71"},{"groupId":"OG001","value":"-1.54","spread":"0.082","lowerLimit":"-1.70","upperLimit":"-1.38"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Superiority of exenatide long-acting release (LAR) once weekly to BYETTA if the upper limit of the 2-sided 95% confidence interval (CI) for treatment difference (LAR minus BYETTA) is less than 0; non-inferiority if this upper limit is less than 0.4%. Power:Assuming 20% dropout rate with 246 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in LAR and a common standard deviation of 1.2%.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide LAR and BYETTA, regulatory guidance, published literature, and statistical considerations.","pValue":"0.0023","statisticalMethod":"ANOVA","statisticalComment":"Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors.","paramType":"Least Squares Mean Difference","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"-0.12","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.107"}]},{"type":"SECONDARY","title":"Change in HbA1c From Baseline to Week 364","description":"Absolute change in HbA1c from Baseline (Day -3) to Week 364","populationDescription":"7-Year Completer Population. Missing data up to Week 364 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"percentage of total hemoglobin","timeFrame":"Day -3, Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.49","spread":"0.155","lowerLimit":"-1.80","upperLimit":"-1.19"},{"groupId":"OG001","value":"-1.57","spread":"0.144","lowerLimit":"-1.85","upperLimit":"-1.28"},{"groupId":"OG002","value":"-1.53","spread":"0.115","lowerLimit":"-1.76","upperLimit":"-1.31"}]}]}]},{"type":"PRIMARY","title":"Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)","description":"Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval","reportingStatus":"NOT_POSTED","timeFrame":"Week 22"},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c Target of <7%","description":"Percentage of subjects achieving HbA1c target value of \\<7% at Week 30.","populationDescription":"ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70.9"},{"groupId":"OG001","value":"51.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Percentages of subjects achieving HbA1c target value of \\<7% at Week 30 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\\<9% or \\>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0003","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c Target of <7%","description":"Percentages of subjects achieving HbA1c target value of \\<7% at Week 364","populationDescription":"7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41.4"},{"groupId":"OG001","value":"50.0"},{"groupId":"OG002","value":"45.9"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c Target of <=6.5%","description":"Percentages of subjects achieving HbA1c target values of \\<=6.5% at Week 30.","populationDescription":"ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.0"},{"groupId":"OG001","value":"16.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Percentage of subjects achieving HbA1c target value of \\<=6.5% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\\<9% or \\>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2042","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c Target of <=6.5%","description":"Percentages of subjects achieving HbA1c target values of \\<=6.5% at Week 364","populationDescription":"7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatmeat"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.4"},{"groupId":"OG001","value":"37.5"},{"groupId":"OG002","value":"30.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving HbA1c Target of <=6.0%","description":"Percentage of subjects achieving HbA1c target values of \\<=6.0% at Week 30.","populationDescription":"ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.0"},{"groupId":"OG001","value":"16.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Percentages of subjects achieving HbA1c target values of \\<=6.0% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\\<9% or \\>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1513","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Exenatide LAR Steady State Concentration From Week 29 to Week 30","description":"Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.","populationDescription":"The Pharmacokinetics Population consisted of subjects who received exenatide LAR treatment, and had adequate plasma exenatide concentration-time data to allow for reliable evaluation of exenatide LAR pharmacokinetics.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"pg/mL","timeFrame":"Week 29 to Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"300.23","lowerLimit":"145.13","upperLimit":"702.21"}]}]}]},{"type":"SECONDARY","title":"Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14","description":"Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14","populationDescription":"Evaluable Meal Tolerance Cohort consisted of ITT subjects who participated in the meal tolerance test and had adequate data to allow the reliable assessment of pharmacodynamics. Only subjects with non-missing baseline and Week 14 values were included in analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Day -3, Week 14","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-95.88","spread":"8.420","lowerLimit":"-112.92","upperLimit":"-78.83"},{"groupId":"OG001","value":"-125.96","spread":"8.292","lowerLimit":"-142.74","upperLimit":"-109.17"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in 2h postprandial glucose from baseline (Day -3) to Week 14 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the 2h postprandial glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline 2h postprandial glucose.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0124","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"30.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.88","ciUpperLimit":"53.28","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"11.458"}]},{"type":"SECONDARY","title":"Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)","description":"Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.","reportingStatus":"NOT_POSTED","timeFrame":"Week 22"},{"type":"SECONDARY","title":"Change in Body Weight From Baseline to Week 30","description":"Change in body weight from baseline (Day -3) to Week 30","populationDescription":"ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Day -3, Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 week)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.67","spread":"0.468","lowerLimit":"-4.59","upperLimit":"-2.75"},{"groupId":"OG001","value":"-3.59","spread":"0.468","lowerLimit":"-4.51","upperLimit":"-2.67"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in body weight from baseline (Day -3) to Week 30 was analyzed using an analysis of covariance (ANCOVA) model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8916","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.29","ciUpperLimit":"1.12","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.612"}]},{"type":"SECONDARY","title":"Change in Body Weight From Baseline to Week 364","description":"Change in body weight from baseline (Day -3) to Week 364","populationDescription":"7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"kg","timeFrame":"Day -3, Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.25","spread":"0.468","lowerLimit":"-7.23","upperLimit":"-3.27"},{"groupId":"OG001","value":"-2.71","spread":"0.468","lowerLimit":"-4.55","upperLimit":"-0.87"},{"groupId":"OG002","value":"-3.87","lowerLimit":"-5.36","upperLimit":"-2.37"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose From Baseline to Week 30","description":"Change in fasting plasma glucose from baseline (Day -3) to Week 30.","populationDescription":"ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Day -3, Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-41.5","spread":"2.97","lowerLimit":"-47.4","upperLimit":"-35.7"},{"groupId":"OG001","value":"-24.6","spread":"2.90","lowerLimit":"-30.3","upperLimit":"-18.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in fasting plasma glucose from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-16.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-24.4","ciUpperLimit":"-9.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.80"}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose From Baseline to Week 364","description":"Change in fasting plasma glucose from baseline (Day -3) to Week 364.","populationDescription":"7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mg/dL","timeFrame":"Day -3, Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-18.3","spread":"2.97","lowerLimit":"-30.8","upperLimit":"-5.7"},{"groupId":"OG001","value":"-27.7","spread":"2.90","lowerLimit":"-39.0","upperLimit":"-16.4"},{"groupId":"OG002","value":"-23.6","lowerLimit":"-33.0","upperLimit":"-14.2"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure From Baseline to Week 30","description":"Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30","populationDescription":"ITT Population using observed data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Day -3, Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"130"}]}],"classes":[{"title":"Sitting Systolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-4.4","spread":"1.04"},{"groupId":"OG001","value":"-3.8","spread":"1.28"}]}]},{"title":"Sitting Diastolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"0.76"},{"groupId":"OG001","value":"-2.3","spread":"0.83"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure From Baseline to Week 364","description":"Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364","populationDescription":"7-Year Completer Population using observed data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Day -3, Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once WeeklyEdit","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"title":"Sitting Systolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"16.21"},{"groupId":"OG001","value":"1.0","spread":"17.32"},{"groupId":"OG002","value":"1.2","spread":"16.73"}]}]},{"title":"Sitting Diastolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1.7","spread":"8.87"},{"groupId":"OG001","value":"-3.6","spread":"9.59"},{"groupId":"OG002","value":"-2.7","spread":"9.26"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol From Baseline to Week 30","description":"Change in total cholesterol from baseline (Day -3) to Week 30.","populationDescription":"ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Day -3, Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"137"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.9","spread":"2.29","lowerLimit":"-16.4","upperLimit":"-7.4"},{"groupId":"OG001","value":"-3.8","spread":"2.35","lowerLimit":"-8.4","upperLimit":"0.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in total cholesterol from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0077","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-8.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.1","ciUpperLimit":"-2.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.04"}]},{"type":"SECONDARY","title":"Change in Total Cholesterol From Baseline to Week 364","description":"Change in total cholesterol from baseline (Day -3) to Week 364.","populationDescription":"7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mg/dL","timeFrame":"Day -3, Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.0","spread":"2.29","lowerLimit":"-23.6","upperLimit":"-6.4"},{"groupId":"OG001","value":"-4.8","spread":"2.35","lowerLimit":"-13.0","upperLimit":"3.3"},{"groupId":"OG002","value":"-9.6","lowerLimit":"-16.2","upperLimit":"-3.0"}]}]}]},{"type":"SECONDARY","title":"Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30","description":"Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.","populationDescription":"ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Day -3, Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"137"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"0.56","lowerLimit":"-2.0","upperLimit":"0.2"},{"groupId":"OG001","value":"-1.3","spread":"0.57","lowerLimit":"-2.5","upperLimit":"-0.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Change in HDL-C from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5613","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.0","ciUpperLimit":"1.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.74"}]},{"type":"SECONDARY","title":"Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364","description":"Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.","populationDescription":"7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mg/dL","timeFrame":"Day -3, Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"0.56","lowerLimit":"-0.2","upperLimit":"4.7"},{"groupId":"OG001","value":"3.4","spread":"0.57","lowerLimit":"1.0","upperLimit":"5.7"},{"groupId":"OG002","value":"2.8","lowerLimit":"1.0","upperLimit":"4.7"}]}]}]},{"type":"SECONDARY","title":"Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364","description":"Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.","populationDescription":"7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mg/dL","timeFrame":"Day -3, Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly -> Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily -> Exenatide Once Weekly","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week."},{"id":"OG002","title":"All Treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.6","spread":"0.56","lowerLimit":"-21.3","upperLimit":"-6.0"},{"groupId":"OG001","value":"-7.5","spread":"0.57","lowerLimit":"-14.7","upperLimit":"-0.3"},{"groupId":"OG002","value":"-10.4","lowerLimit":"-16.2","upperLimit":"-4.6"}]}]}]},{"type":"SECONDARY","title":"Ratio of Triglycerides at Week 30 to Baseline","description":"Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.","populationDescription":"ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"Day -3, Week 30","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Subcutaneous injection of 2 mg exenatide, once a week."},{"id":"OG001","title":"Exenatide Twice Daily","description":"Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"137"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.85","spread":"0.029","lowerLimit":"0.80","upperLimit":"0.91"},{"groupId":"OG001","value":"0.89","spread":"0.031","lowerLimit":"0.84","upperLimit":"0.96"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day -3), expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\\<9% or \\>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2915","statisticalMethod":"ANCOVA","paramType":"Geometic Least Squares Mean Ratio","paramValue":"0.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.87","ciUpperLimit":"1.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.042"}]},{"type":"SECONDARY","title":"Ratio of Triglycerides at Week 364 to Baseline","description":"Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.","populationDescription":"7-Year Completer Population. 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The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.","populationDescription":"ITT Population who participated in the 30-week assessment period and using SU at screening.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"events per subject-year","timeFrame":"Day 1 to Week 364","groups":[{"id":"OG000","title":"Exenatide Once Weekly With SU","description":"Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 0 to week 30."},{"id":"OG001","title":"Exenatide Twice Daily With SU","description":"Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) using concomitant SU at screening. Week 0 to week 30."},{"id":"OG002","title":"Exenatide Once Weekly -> Exenatide Once Weekly With SU","description":"Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364"},{"id":"OG003","title":"Exenatide Twice Daily -> Exenatide Once Weekly With SU","description":"Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364."},{"id":"OG004","title":"Exenatide Once Weekly With SU","description":"Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. 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