{"protocolSection":{"identificationModule":{"nctId":"NCT01733758","orgStudyIdInfo":{"id":"113121"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2016-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-02"},"primaryCompletionDateStruct":{"date":"2014-06","type":"ACTUAL"},"completionDateStruct":{"date":"2015-02","type":"ACTUAL"},"studyFirstSubmitDate":"2012-11-21","studyFirstSubmitQcDate":"2012-11-21","studyFirstPostDateStruct":{"date":"2012-11-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-04-02","resultsFirstSubmitQcDate":"2015-04-30","resultsFirstPostDateStruct":{"date":"2015-05-18","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-08-12","lastUpdatePostDateStruct":{"date":"2016-09-22","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"GlaxoSmithKline","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["albiglutide","Japanese","GSK716155","Type 2 diabetes mellitus","glucagon-like peptide 1"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":494,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Albiglutide 30 mg weekly","type":"EXPERIMENTAL","description":"Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks","interventionNames":["Drug: Albiglutide 30 mg weekly","Drug: Placebo"]},{"label":"Albiglutide 50 mg weekly","type":"EXPERIMENTAL","description":"Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52","interventionNames":["Drug: Albiglutide 50 mg weekly"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52","interventionNames":["Drug: Placebo"]},{"label":"Liraglutide 0.9 mg daily","type":"ACTIVE_COMPARATOR","description":"Subjects will be randomly assigned to open-label liraglutide for 52 weeks","interventionNames":["Drug: Liraglutide 0.9 mg daily"]}],"interventions":[{"type":"DRUG","name":"Albiglutide 30 mg weekly","description":"Albiglutide will be available as a pen injector that delivers 30mg of albiglutide","armGroupLabels":["Albiglutide 30 mg weekly"]},{"type":"DRUG","name":"Albiglutide 50 mg weekly","description":"Albiglutide will be available as a pen injector that delivers 50mg of albiglutide","armGroupLabels":["Albiglutide 50 mg weekly"]},{"type":"DRUG","name":"Placebo","description":"Albiglutide matching placebo will be available as a pen injector","armGroupLabels":["Albiglutide 30 mg weekly","Placebo"]},{"type":"DRUG","name":"Liraglutide 0.9 mg daily","description":"Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose","armGroupLabels":["Liraglutide 0.9 mg daily"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (\\<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.","timeFrame":"Baseline and Week 24"},{"measure":"Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.","timeFrame":"Baseline and Week 24"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c at Week 52","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.","timeFrame":"Baseline and Week 52"},{"measure":"Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as \\<6.5% and \\<7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.","timeFrame":"Week 24"},{"measure":"Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as \\<6.5% and \\<7.0%.","timeFrame":"Week 52"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24","description":"FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.","timeFrame":"Baseline and Week 24"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52","description":"FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in Body Weight at Week 24","description":"The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.","timeFrame":"Baseline and Week 24"},{"measure":"Change From Baseline in Body Weight at Week 52","description":"The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.","timeFrame":"Baseline and Week 52"},{"measure":"Time to Study Withdrawal Due to Hyperglycemia","description":"Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to \\<Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to \\<Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to \\<Week 52, confirmed a second evaluation within 7 days.","timeFrame":"Baseline through Week 52"},{"measure":"Time to Study Withdrawal for Any Reason","description":"Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.","timeFrame":"Baseline through Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening\n* Body mass index (BMI) 17 to 40 kg/ m\\^2 inclusive\n* Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2\n* Creatinine clearance \\>30 mL/min (calculated using the Cockcroft-Gault formula)\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or \\<6 weeks postpartum•\n* Clinically significant cardiovascular and/or cerebrovascular disease\n* Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator\n* Serum amylase \\>=3 ×ULN and/or serum lipase \\>=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis\n* Prior use of a TZD or GLP-1R agonist within 4 months before Screening","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"GSK Clinical Trials","affiliation":"GlaxoSmithKline","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"GSK Investigational Site","city":"Aichi","zip":"456-0058","country":"Japan","geoPoint":{"lat":32.51879,"lon":130.62158}},{"facility":"GSK Investigational Site","city":"Chiba","zip":"263-0043","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"GSK Investigational Site","city":"Ehime","zip":"790-0067","country":"Japan"},{"facility":"GSK Investigational Site","city":"Ehime","zip":"792-0045","country":"Japan"},{"facility":"GSK Investigational 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Register"},{"id":"113121","type":"Annotated Case Report Form","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"113121","type":"Individual Participant Data Set","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"113121","type":"Clinical Study Report","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"113121","type":"Study Protocol","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"113121","type":"Informed Consent Form","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"113121","type":"Statistical Analysis Plan","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site."}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"A total of 494 participants (par.) were randomized to one of the four treatment groups - placebo (switched to albiglutide 30 mg at Week 24), albiglutide 30 mg, albiglutide 50 mg, liraglutide (open label), 490 par. took at least one dose of study drug (Safety Population). All 490 par. were included in Intent-to-Treat Population.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52."},{"id":"FG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"FG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"FG003","title":"Open Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"160"},{"groupId":"FG002","numSubjects":"150"},{"groupId":"FG003","numSubjects":"103"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"148"},{"groupId":"FG002","numSubjects":"135"},{"groupId":"FG003","numSubjects":"95"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"8"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Persistent Hyperglycemia","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Non-compliance","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Intro of New Anti-Diabetic Medication","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Inv Decision, HbA1c not controlled","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Baseline characteristics are presented for the Safety Population.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"BG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"BG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"BG003","title":"Open Label Liraglutide 0.9 mg Daily","description":"Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"160"},{"groupId":"BG002","value":"150"},{"groupId":"BG003","value":"103"},{"groupId":"BG004","value":"490"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.3","spread":"11.27"},{"groupId":"BG001","value":"59.6","spread":"9.00"},{"groupId":"BG002","value":"57.7","spread":"9.51"},{"groupId":"BG003","value":"58.4","spread":"9.72"},{"groupId":"BG004","value":"58.4","spread":"9.70"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"36"},{"groupId":"BG003","value":"22"},{"groupId":"BG004","value":"118"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"125"},{"groupId":"BG002","value":"114"},{"groupId":"BG003","value":"81"},{"groupId":"BG004","value":"372"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Asian - Japanese Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"160"},{"groupId":"BG002","value":"150"},{"groupId":"BG003","value":"103"},{"groupId":"BG004","value":"490"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (\\<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.","populationDescription":"Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c in the blood","timeFrame":"Baseline and Week 24","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"159"},{"groupId":"OG002","value":"150"},{"groupId":"OG003","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.25","spread":"0.068"},{"groupId":"OG001","value":"-1.10","spread":"0.047"},{"groupId":"OG002","value":"-1.30","spread":"0.049"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.55","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.72","ciUpperLimit":"-1.39"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.51","ciUpperLimit":"-1.18"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.","statisticalMethod":"t-test, 2 sided","statisticalComment":"The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg - placebo) is equal to zero.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.","statisticalMethod":"t-test, 2 sided","statisticalComment":"The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg - placebo) is equal to zero.","ciPctValue":"95"}]},{"type":"PRIMARY","title":"Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.","populationDescription":"Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c in the blood","timeFrame":"Baseline and Week 24","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"159"},{"groupId":"OG002","value":"150"},{"groupId":"OG003","value":"103"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"8.16","spread":"0.877"},{"groupId":"OG001","value":"8.06","spread":"0.783"},{"groupId":"OG002","value":"8.15","spread":"0.825"},{"groupId":"OG003","value":"8.07","spread":"0.787"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"8.39","spread":"1.066"},{"groupId":"OG001","value":"6.98","spread":"0.735"},{"groupId":"OG002","value":"6.83","spread":"0.659"},{"groupId":"OG003","value":"6.87","spread":"0.642"}]}]},{"title":"Change from Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"0.24","spread":"0.715"},{"groupId":"OG001","value":"-1.08","spread":"0.619"},{"groupId":"OG002","value":"-1.32","spread":"0.702"},{"groupId":"OG003","value":"-1.19","spread":"0.636"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c at Week 52","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.","populationDescription":"Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c in the blood","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"148"},{"groupId":"OG002","value":"135"},{"groupId":"OG003","value":"95"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.07","spread":"0.695"},{"groupId":"OG001","value":"-1.07","spread":"0.790"},{"groupId":"OG002","value":"-1.34","spread":"0.753"},{"groupId":"OG003","value":"-1.17","spread":"0.776"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as \\<6.5% and \\<7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.","populationDescription":"Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"159"},{"groupId":"OG002","value":"150"},{"groupId":"OG003","value":"103"}]}],"classes":[{"title":"HbA1c <6.5% at Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"29"}]}]},{"title":"HbA1c <7.0% at Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"100"},{"groupId":"OG003","value":"66"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as \\<6.5% and \\<7.0%.","populationDescription":"Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"148"},{"groupId":"OG002","value":"135"},{"groupId":"OG003","value":"95"}]}],"classes":[{"title":"HbA1c <6.5% at Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"27"}]}]},{"title":"HbA1c <7.0% at Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"85"},{"groupId":"OG003","value":"57"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24","description":"FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.","populationDescription":"Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Milligrams per deciliter (mg/dL)","timeFrame":"Baseline and Week 24","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"159"},{"groupId":"OG002","value":"150"},{"groupId":"OG003","value":"103"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"159.3","spread":"37.07"},{"groupId":"OG001","value":"157.1","spread":"33.81"},{"groupId":"OG002","value":"158.7","spread":"32.82"},{"groupId":"OG003","value":"157.2","spread":"31.22"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"167.0","spread":"37.51"},{"groupId":"OG001","value":"132.2","spread":"26.09"},{"groupId":"OG002","value":"128.8","spread":"24.03"},{"groupId":"OG003","value":"128.1","spread":"23.68"}]}]},{"title":"Change from Baseline at Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"7.7","spread":"31.77"},{"groupId":"OG001","value":"-24.9","spread":"27.58"},{"groupId":"OG002","value":"-30.0","spread":"27.83"},{"groupId":"OG003","value":"-29.1","spread":"29.00"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52","description":"FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.","populationDescription":"Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in this analysis. No missing data were imputed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Milligrams per deciliter (mg/dL)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"147"},{"groupId":"OG002","value":"135"},{"groupId":"OG003","value":"95"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"154.5","spread":"35.65"},{"groupId":"OG001","value":"154.7","spread":"29.36"},{"groupId":"OG002","value":"159.8","spread":"33.52"},{"groupId":"OG003","value":"157.4","spread":"30.27"}]}]},{"title":"Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"131.7","spread":"23.13"},{"groupId":"OG001","value":"131.9","spread":"24.14"},{"groupId":"OG002","value":"126.3","spread":"24.47"},{"groupId":"OG003","value":"127.0","spread":"20.78"}]}]},{"title":"Change from Baseline at Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"-22.7","spread":"27.38"},{"groupId":"OG001","value":"-22.8","spread":"26.03"},{"groupId":"OG002","value":"-33.5","spread":"31.10"},{"groupId":"OG003","value":"-30.4","spread":"28.06"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 24","description":"The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.","populationDescription":"Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms (kg)","timeFrame":"Baseline and Week 24","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"159"},{"groupId":"OG002","value":"150"},{"groupId":"OG003","value":"103"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"68.65","spread":"12.088"},{"groupId":"OG001","value":"69.46","spread":"13.453"},{"groupId":"OG002","value":"71.54","spread":"12.907"},{"groupId":"OG003","value":"72.65","spread":"13.758"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"68.15","spread":"12.139"},{"groupId":"OG001","value":"69.78","spread":"13.793"},{"groupId":"OG002","value":"71.50","spread":"13.023"},{"groupId":"OG003","value":"72.30","spread":"13.459"}]}]},{"title":"Change from Baseline at Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"-0.50","spread":"1.700"},{"groupId":"OG001","value":"0.32","spread":"1.795"},{"groupId":"OG002","value":"-0.04","spread":"1.976"},{"groupId":"OG003","value":"-0.34","spread":"2.587"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 52","description":"The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.","populationDescription":"Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued before Week 52 from study treatment were not included in the analysis. No missing data were imputed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms (kg)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"148"},{"groupId":"OG002","value":"135"},{"groupId":"OG003","value":"95"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"68.07","spread":"11.978"},{"groupId":"OG001","value":"70.07","spread":"13.242"},{"groupId":"OG002","value":"71.27","spread":"12.801"},{"groupId":"OG003","value":"72.43","spread":"12.895"}]}]},{"title":"Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"68.00","spread":"12.150"},{"groupId":"OG001","value":"70.15","spread":"13.536"},{"groupId":"OG002","value":"70.96","spread":"12.431"},{"groupId":"OG003","value":"71.93","spread":"12.564"}]}]},{"title":"Change from Baseline at Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"2.179"},{"groupId":"OG001","value":"0.08","spread":"2.078"},{"groupId":"OG002","value":"-0.31","spread":"2.382"},{"groupId":"OG003","value":"-0.50","spread":"2.690"}]}]}]},{"type":"SECONDARY","title":"Time to Study Withdrawal Due to Hyperglycemia","description":"Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to \\<Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to \\<Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to \\<Week 52, confirmed a second evaluation within 7 days.","populationDescription":"Intent-to-Treat Population: all randomized par. who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Par. who did not conform to the protocol-defined criteria of persistent hyperglycemia with respect to FPG values defined above were not included in this analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Weeks","timeFrame":"Baseline through Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"150"},{"groupId":"OG003","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval."},{"groupId":"OG002","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval."},{"groupId":"OG003","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval."}]}]}]},{"type":"SECONDARY","title":"Time to Study Withdrawal for Any Reason","description":"Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. 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After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52."},{"id":"OG003","title":"Open-Label Liraglutide 0.9 mg Daily","description":"Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"150"},{"groupId":"OG003","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of withdrawals for any reason to calculate the median and confidence interval."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of withdrawals for any reason to calculate the median and confidence interval."},{"groupId":"OG002","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of withdrawals for any reason to calculate the median and confidence interval."},{"groupId":"OG003","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of withdrawals for any reason to calculate the median and confidence interval."}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"On-therapy non-serious AEs and serious AEs (SAEs), events with an onset on or after the start date of study treatment and within 56 days after the date of the last dose of study treatment, are summarized through Week 52.","description":"The nonserious AEs and SAEs are reported for the Safety Population, comprised of all participants who received \\>= 1 dose of study treatment. 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GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial."},"pointOfContact":{"title":"GSK Response Center","organization":"GlaxoSmithKline","phone":"866-435-7343"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C534611","term":"rGLP-1 protein"},{"id":"D000069450","term":"Liraglutide"}],"ancestors":[{"id":"D052216","term":"Glucagon-Like Peptide 1"},{"id":"D004763","term":"Glucagon-Like Peptides"},{"id":"D052336","term":"Proglucagon"},{"id":"D005768","term":"Gastrointestinal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"}]}},"hasResults":true}