{"protocolSection":{"identificationModule":{"nctId":"NCT02229396","orgStudyIdInfo":{"id":"D5553C00003"},"secondaryIdInfos":[{"id":"2014-003503-29","type":"EUDRACT_NUMBER"},{"id":"2014","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2014"}],"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo","officialTitle":"A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin"},"statusModule":{"statusVerifiedDate":"2018-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-09-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-04-26","type":"ACTUAL"},"completionDateStruct":{"date":"2017-12-28","type":"ACTUAL"},"studyFirstSubmitDate":"2014-08-28","studyFirstSubmitQcDate":"2014-08-28","studyFirstPostDateStruct":{"date":"2014-09-01","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-08-09","resultsFirstSubmitQcDate":"2017-08-09","resultsFirstPostDateStruct":{"date":"2017-09-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-12-06","lastUpdatePostDateStruct":{"date":"2018-12-31","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin."},"conditionsModule":{"conditions":["Diabetes Mellitus"],"keywords":["Diabetes Mellitus","Exenatide","Dapagliflozin","Diabetes medication","Treatment efficacy","Placebo","Metabolism","Cardiovascular metabolic"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":695,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 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Achieving HbA1c <7% at Week 28","description":"To compare the percentage of patients achieving HbA1c \\<7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.","timeFrame":"Baseline to Week 28"},{"measure":"Change in Systolic Blood Pressure From Baseline to Week 28","description":"To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.","timeFrame":"Baseline to Week 28"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria\n\n* Has a diagnosis of T2DM.\n* Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.\n* Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.\n\nExclusion criteria\n\n* FPG ≥280 mg/dL (15.6 mmol/L).\n* Serum calcitonin 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Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial. Diabetes Care. 2020 Oct;43(10):2528-2536. doi: 10.2337/dc19-1350. Epub 2020 Aug 18."},{"pmid":"32306296","type":"DERIVED","citation":"Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18."},{"pmid":"30082326","type":"DERIVED","citation":"Jabbour SA, Frias JP, Hardy E, Ahmed A, Wang H, Ohman P, Guja C. Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the DURATION-8 Randomized Controlled Trial. Diabetes Care. 2018 Oct;41(10):2136-2146. doi: 10.2337/dc18-0680. Epub 2018 Aug 6."},{"pmid":"27651331","type":"DERIVED","citation":"Frias JP, Guja C, Hardy E, Ahmed A, Dong F, Ohman P, Jabbour SA. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Dec;4(12):1004-1016. doi: 10.1016/S2213-8587(16)30267-4. Epub 2016 Sep 16."}],"seeAlsoLinks":[{"label":"CSP\\_radacted","url":"http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3057&filename=d5553c00003_revised_csp_3_Redacted.pdf"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study had a Screening Visit, a 1-week placebo Lead-in Period, a Randomization Visit, and 9 further visits at 1- to 4-week intervals during a 28-week Treatment Period. Patients then entered a 24-week Extension Period 1 and subsequent 52-week Extension Period 2. A follow-up visit occurred 10 weeks after last dose of study medication.","recruitmentDetails":"Study conducted between 04 September 2014 and 28 December 2017. 118 centers in 6 countries randomized patients in the study. A Primary Analysis was performed following completion of the 28-week Treatment Period with a data cut-off date of 26 April 2016. 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Patients continued to administer the same type and dose of metformin therapy they were using at study entry."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"233"},{"groupId":"FG001","numSubjects":"231"},{"groupId":"FG002","numSubjects":"231"}]},{"type":"Randomization Code Allocated","achievements":[{"groupId":"FG000","numSubjects":"233"},{"groupId":"FG001","numSubjects":"231"},{"groupId":"FG002","numSubjects":"231"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"233"},{"groupId":"FG001","numSubjects":"231"},{"groupId":"FG002","numSubjects":"230"}]},{"type":"Intent-to-Treat (ITT) Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"230"},{"groupId":"FG001","numSubjects":"228"},{"groupId":"FG002","numSubjects":"227"}]},{"type":"Completed 28-Week Study Period","achievements":[{"groupId":"FG000","numSubjects":"208"},{"groupId":"FG001","numSubjects":"202"},{"groupId":"FG002","numSubjects":"193"}]},{"type":"Completed 52-Week Study Period","achievements":[{"groupId":"FG000","numSubjects":"194"},{"groupId":"FG001","numSubjects":"193"},{"groupId":"FG002","numSubjects":"177"}]},{"type":"COMPLETED","comment":"Completed 104-Week Study Period","achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"154"},{"groupId":"FG002","numSubjects":"136"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"95"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"12"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"21"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Patient Incorrectly Randomized","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"15"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"41"}]},{"type":"Study-Specific Withdrawal Criteria","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Withdrew; No Record on Termination Page","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The overall number of baseline participants is comprised of the ITT analysis set, defined as all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline hemoglobin A1c (HbA1c) assessment.","groups":[{"id":"BG000","title":"Dapagliflozin + Placebo","description":"Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"BG001","title":"Exenatide + Dapagliflozin","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"BG002","title":"Exenatide + Placebo","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"230"},{"groupId":"BG001","value":"228"},{"groupId":"BG002","value":"227"},{"groupId":"BG003","value":"685"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.5","spread":"9.16","lowerLimit":"28","upperLimit":"75"},{"groupId":"BG001","value":"53.8","spread":"9.82","lowerLimit":"26","upperLimit":"80"},{"groupId":"BG002","value":"54.2","spread":"9.62","lowerLimit":"29","upperLimit":"80"},{"groupId":"BG003","value":"54.2","spread":"9.53","lowerLimit":"26","upperLimit":"80"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"126"},{"groupId":"BG002","value":"111"},{"groupId":"BG003","value":"357"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"110"},{"groupId":"BG001","value":"102"},{"groupId":"BG002","value":"116"},{"groupId":"BG003","value":"328"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"American Indian Or Alaska Native","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"5"}]}]},{"title":"Black Or African American","categories":[{"measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"94"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"11"}]}]},{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"189"},{"groupId":"BG001","value":"190"},{"groupId":"BG002","value":"194"},{"groupId":"BG003","value":"573"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c From Baseline to Week 28","description":"To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.","populationDescription":"The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"% HbA1c","timeFrame":"Baseline to Week 28","groups":[{"id":"OG000","title":"Dapagliflozin + Placebo","description":"Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG001","title":"Exenatide + Dapagliflozin","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG002","title":"Exenatide + Placebo","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"228"},{"groupId":"OG002","value":"227"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.39","lowerLimit":"-1.57","upperLimit":"-1.21"},{"groupId":"OG001","value":"-1.98","lowerLimit":"-2.16","upperLimit":"-1.79"},{"groupId":"OG002","value":"-1.60","lowerLimit":"-1.79","upperLimit":"-1.41"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Treatment, region, baseline HbA1c stratum (\\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.","paramType":"Mean Difference (Final Values)","paramValue":"-0.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"-0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.129"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Treatment, region, baseline HbA1c stratum (\\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.","paramType":"Mean Difference (Final Values)","paramValue":"-0.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.84","ciUpperLimit":"-0.34","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.127"}]},{"type":"SECONDARY","title":"Change in Body Weight From Baseline to Week 28","description":"To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.","populationDescription":"The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"kilogram","timeFrame":"Baseline to Week 28","groups":[{"id":"OG000","title":"Dapagliflozin + Placebo","description":"Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG001","title":"Exenatide + Dapagliflozin","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG002","title":"Exenatide + Placebo","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"228"},{"groupId":"OG002","value":"227"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.22","lowerLimit":"-2.78","upperLimit":"-1.66"},{"groupId":"OG001","value":"-3.55","lowerLimit":"-4.12","upperLimit":"-2.99"},{"groupId":"OG002","value":"-1.56","lowerLimit":"-2.13","upperLimit":"-0.98"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Treatment, region, baseline HbA1c stratum (\\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.","paramType":"Mean Difference (Final Values)","paramValue":"-2.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.79","ciUpperLimit":"-1.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.406"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Treatment, region, baseline HbA1c stratum (\\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.","paramType":"Mean Difference (Final Values)","paramValue":"-1.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.12","ciUpperLimit":"-0.55","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.400"}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose From Baseline to Week 28","description":"To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.","populationDescription":"The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"milligrams/deciliter (mg/dL)","timeFrame":"Baseline to Week 28","groups":[{"id":"OG000","title":"Dapagliflozin + Placebo","description":"Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG001","title":"Exenatide + Dapagliflozin","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG002","title":"Exenatide + Placebo","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"228"},{"groupId":"OG002","value":"227"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-49.19","lowerLimit":"-54.91","upperLimit":"-43.47"},{"groupId":"OG001","value":"-65.83","lowerLimit":"-71.60","upperLimit":"-60.06"},{"groupId":"OG002","value":"-45.75","lowerLimit":"-51.67","upperLimit":"-39.83"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Treatment, region, baseline HbA1c stratum (\\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.","paramType":"Mean Difference (Final Values)","paramValue":"-20.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-27.95","ciUpperLimit":"-12.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.007"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Treatment, region, baseline HbA1c stratum (\\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.","paramType":"Mean Difference (Final Values)","paramValue":"-16.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-24.39","ciUpperLimit":"-8.89","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.947"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test","description":"To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.","populationDescription":"The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mg/dL","timeFrame":"Baseline to Week 28","groups":[{"id":"OG000","title":"Dapagliflozin + Placebo","description":"Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG001","title":"Exenatide + Dapagliflozin","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG002","title":"Exenatide + Placebo","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"228"},{"groupId":"OG002","value":"227"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-61.05","lowerLimit":"-69.10","upperLimit":"-53.00"},{"groupId":"OG001","value":"-87.83","lowerLimit":"-95.83","upperLimit":"-79.84"},{"groupId":"OG002","value":"-60.09","lowerLimit":"-68.48","upperLimit":"-51.71"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","statisticalComment":"Treatment, region, and baseline HbA1c stratum (\\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.","paramType":"Mean Difference (Final Values)","paramValue":"-27.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-37.89","ciUpperLimit":"-17.59","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.168"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","statisticalComment":"Treatment, region, and baseline HbA1c stratum (\\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.","paramType":"Mean Difference (Final Values)","paramValue":"-26.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-36.78","ciUpperLimit":"-16.78","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.090"}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28","description":"To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.","populationDescription":"The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"% of patients","timeFrame":"Baseline to Week 28","groups":[{"id":"OG000","title":"Dapagliflozin + Placebo","description":"Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG001","title":"Exenatide + Dapagliflozin","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry."},{"id":"OG002","title":"Exenatide + Placebo","description":"Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. 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