{"protocolSection":{"identificationModule":{"nctId":"NCT01777282","orgStudyIdInfo":{"id":"116170"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus","officialTitle":"A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2017-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-02-23","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-01-27","type":"ACTUAL"},"completionDateStruct":{"date":"2015-01-27","type":"ACTUAL"},"studyFirstSubmitDate":"2013-01-24","studyFirstSubmitQcDate":"2013-01-24","studyFirstPostDateStruct":{"date":"2013-01-28","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-09-14","resultsFirstSubmitQcDate":"2015-09-14","resultsFirstPostDateStruct":{"date":"2015-10-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-03-30","lastUpdatePostDateStruct":{"date":"2017-05-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"GlaxoSmithKline","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.","detailedDescription":"This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added."},"conditionsModule":{"conditions":["Diabetes Mellitus"],"keywords":["albiglutide","Japanese","glucagon-like peptide-1","GSK716155"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":374,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Albiglutide + Sulfonylurea","type":"ACTIVE_COMPARATOR","description":"Albiglutide in combination with background sulfonylurea","interventionNames":["Drug: Albiglutide","Drug: Sulfonylurea"]},{"label":"Albiglutide + Biguanide","type":"ACTIVE_COMPARATOR","description":"Albiglutide in combination with background biguanide","interventionNames":["Drug: Albiglutide","Drug: Biguanide"]},{"label":"Albiglutide + Glinide","type":"ACTIVE_COMPARATOR","description":"Albiglutide in combination with background glinide","interventionNames":["Drug: Albiglutide","Drug: Glinide"]},{"label":"Albiglutide + Thiazolidinedione","type":"ACTIVE_COMPARATOR","description":"Albiglutide in combination with background thiazolidinedione","interventionNames":["Drug: Albiglutide","Drug: Thiazolidinedione"]},{"label":"Albiglutide + Alpha-glucosidase inhibitor","type":"ACTIVE_COMPARATOR","description":"Albiglutide in combination with background alpha-glucosidase inhibitor","interventionNames":["Drug: Albiglutide","Drug: Alpha-glucosidase inhibitor"]}],"interventions":[{"type":"DRUG","name":"Albiglutide","description":"Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.","armGroupLabels":["Albiglutide + Alpha-glucosidase inhibitor","Albiglutide + Biguanide","Albiglutide + Glinide","Albiglutide + Sulfonylurea","Albiglutide + Thiazolidinedione"]},{"type":"DRUG","name":"Sulfonylurea","description":"Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.","armGroupLabels":["Albiglutide + Sulfonylurea"]},{"type":"DRUG","name":"Biguanide","description":"Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.","armGroupLabels":["Albiglutide + Biguanide"]},{"type":"DRUG","name":"Glinide","description":"Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.","armGroupLabels":["Albiglutide + Glinide"]},{"type":"DRUG","name":"Thiazolidinedione","description":"Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.","armGroupLabels":["Albiglutide + Thiazolidinedione"]},{"type":"DRUG","name":"Alpha-glucosidase inhibitor","description":"Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.","armGroupLabels":["Albiglutide + Alpha-glucosidase inhibitor"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)","description":"An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.","timeFrame":"From Baseline through Week 52"},{"measure":"Number of Participants With Any Hypoglycemic Event","description":"Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.","timeFrame":"From Baseline through Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Hemoglobin (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 before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.","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 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 before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. 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 52","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 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.","timeFrame":"Baseline and Week 52"},{"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. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.","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 \\>=280 mg/dL (\\>=15.5 mmol/L) from \\>=Week 2 to \\<Week 12 or \\>=230 mg/dL (\\>=12.8 mmol/L) from \\>=Week 12 to \\<Week 52.","timeFrame":"Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication\n* Body mass index (BMI) 17 to 40 kg/ m2 inclusive\n* Subjects with an HbA1c between 7.0% and 10.0% at Screening\n* Creatinine clearance \\>30 mL/min (calculated using the Cockcroft-Gault formula)\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus\n* 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 GLP-1R agonist or DPP-IV inhibitor within 6 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":"792-8586","country":"Japan"},{"facility":"GSK Investigational Site","city":"Fukuoka","zip":"810-0014","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"GSK Investigational Site","city":"Fukuoka","zip":"815-8588","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"GSK Investigational Site","city":"Fukuoka","zip":"819-0168","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"GSK Investigational Site","city":"Fukushima","zip":"960-0418","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"facility":"GSK Investigational Site","city":"Fukushima","zip":"963-8851","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"facility":"GSK Investigational Site","city":"Gunma","zip":"370-3573","country":"Japan"},{"facility":"GSK Investigational Site","city":"Gunma","zip":"379-0116","country":"Japan"},{"facility":"GSK Investigational Site","city":"Hokkaido","zip":"040-8585","country":"Japan"},{"facility":"GSK Investigational Site","city":"Hokkaido","zip":"070-0002","country":"Japan"},{"facility":"GSK Investigational Site","city":"Ibaraki","zip":"300-0835","country":"Japan","geoPoint":{"lat":34.81641,"lon":135.56828}},{"facility":"GSK Investigational Site","city":"Ibaraki","zip":"311-0113","country":"Japan","geoPoint":{"lat":34.81641,"lon":135.56828}},{"facility":"GSK Investigational Site","city":"Kagawa","zip":"760-0076","country":"Japan","geoPoint":{"lat":34.06667,"lon":131.03333}},{"facility":"GSK Investigational Site","city":"Kagoshima","zip":"890-0061","country":"Japan","geoPoint":{"lat":31.56667,"lon":130.55}},{"facility":"GSK Investigational Site","city":"Kanagawa","zip":"232-0064","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"GSK Investigational Site","city":"Kanagawa","zip":"235-0045","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"GSK Investigational Site","city":"Kanagawa","zip":"252-0302","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"GSK Investigational Site","city":"Kanagawa","zip":"253-0044","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"GSK Investigational Site","city":"Kochi","zip":"780-0088","country":"Japan","geoPoint":{"lat":33.55,"lon":133.53333}},{"facility":"GSK Investigational Site","city":"Kumamoto","zip":"862-0960","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"GSK Investigational Site","city":"Kumamoto","zip":"867-0041","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"GSK Investigational Site","city":"Kyoto","zip":"600-8558","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"GSK Investigational Site","city":"Kyoto","zip":"601-1495","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"GSK Investigational Site","city":"Kyoto","zip":"601-8325","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"GSK Investigational Site","city":"Miyagi","zip":"980-0021","country":"Japan","geoPoint":{"lat":26.62566,"lon":128.18236}},{"facility":"GSK Investigational Site","city":"Miyagi","zip":"985-0852","country":"Japan","geoPoint":{"lat":26.62566,"lon":128.18236}},{"facility":"GSK Investigational Site","city":"Nagano","zip":"399-0006","country":"Japan","geoPoint":{"lat":36.65,"lon":138.18333}},{"facility":"GSK Investigational Site","city":"Nagano","zip":"399-0036","country":"Japan","geoPoint":{"lat":36.65,"lon":138.18333}},{"facility":"GSK Investigational Site","city":"Okinawa","zip":"900-0029","country":"Japan","geoPoint":{"lat":26.33583,"lon":127.80139}},{"facility":"GSK Investigational Site","city":"Osaka","zip":"530-0012","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"GSK Investigational Site","city":"Osaka","zip":"536-0023","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"GSK Investigational Site","city":"Osaka","zip":"538-0044","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"GSK Investigational Site","city":"Osaka","zip":"577-0803","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"GSK Investigational Site","city":"Osaka","zip":"582-0019","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"GSK Investigational Site","city":"Ōita","zip":"870-0039","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}},{"facility":"GSK Investigational Site","city":"Saitama","zip":"332-0012","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"GSK Investigational Site","city":"Saitama","zip":"350-0035","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"GSK Investigational Site","city":"Saitama","zip":"350-0851","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"GSK Investigational Site","city":"Saitama","zip":"354-0031","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"GSK Investigational Site","city":"Saitama","zip":"355-0321","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"GSK Investigational Site","city":"Saitama","zip":"358-0011","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"GSK Investigational Site","city":"Shizuoka","zip":"424-0855","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}},{"facility":"GSK Investigational Site","city":"Tochigi","zip":"329-0433","country":"Japan","geoPoint":{"lat":36.38333,"lon":139.73333}},{"facility":"GSK Investigational Site","city":"Tokyo","zip":"103-0002","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"GSK Investigational Site","city":"Tokyo","zip":"103-0027","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"GSK Investigational Site","city":"Tokyo","zip":"125-0054","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"GSK Investigational Site","city":"Tokyo","zip":"143-0015","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}}]},"referencesModule":{"references":[{"pmid":"27852119","type":"DERIVED","citation":"Okuda I, Wilson TH, Yue L, Nakajima H, Carr MC, Tsuboi M, Nino A, Seino Y. Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs. Curr Med Res Opin. 2017 Mar;33(3):431-438. doi: 10.1080/03007995.2016.1261817. Epub 2016 Dec 21."}],"seeAlsoLinks":[{"label":"Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.","url":"https://www.clinicalstudydatarequest.com"}],"availIpds":[{"id":"116170","type":"Dataset Specification","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"116170","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":"116170","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":"116170","type":"Study Protocol","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"116170","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":"116170","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":{"preAssignmentDetails":"Eligible participants entered a 2-week Screening Period; a 52-week Treatment Period and an 8-week Follow-up (FU) Period.","recruitmentDetails":"A total of 360 participants with type 2 diabetes mellitus (T2DM) were planned and 374 participants were enrolled and analyzed in the Safety Population; the Safety Population and Intent-to-Treat Population were identical in this study.","groups":[{"id":"FG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"FG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"FG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"FG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"FG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"120"},{"groupId":"FG001","numSubjects":"67"},{"groupId":"FG002","numSubjects":"65"},{"groupId":"FG003","numSubjects":"61"},{"groupId":"FG004","numSubjects":"61"}]},{"type":"Completing Treatment Period","achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"63"},{"groupId":"FG002","numSubjects":"59"},{"groupId":"FG003","numSubjects":"59"},{"groupId":"FG004","numSubjects":"54"}]},{"type":"Completing Follow-up Period","achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"63"},{"groupId":"FG002","numSubjects":"59"},{"groupId":"FG003","numSubjects":"59"},{"groupId":"FG004","numSubjects":"54"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"63"},{"groupId":"FG002","numSubjects":"59"},{"groupId":"FG003","numSubjects":"59"},{"groupId":"FG004","numSubjects":"54"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Persistent Hyperglycemia","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"New Antidiabetic Medication","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"}]},{"type":"Moved, transfer abroad, did not enter FU","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"BG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"BG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"BG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"BG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"65"},{"groupId":"BG003","value":"61"},{"groupId":"BG004","value":"61"},{"groupId":"BG005","value":"374"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.5","spread":"9.19"},{"groupId":"BG001","value":"57.0","spread":"8.55"},{"groupId":"BG002","value":"55.7","spread":"11.07"},{"groupId":"BG003","value":"59.0","spread":"10.54"},{"groupId":"BG004","value":"57.4","spread":"10.47"},{"groupId":"BG005","value":"57.7","spread":"9.89"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"108"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"87"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"50"},{"groupId":"BG004","value":"41"},{"groupId":"BG005","value":"266"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Asian - Japanese Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"65"},{"groupId":"BG003","value":"61"},{"groupId":"BG004","value":"61"},{"groupId":"BG005","value":"374"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)","description":"An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.","populationDescription":"Safety Population: all participants who received at least 1 dose of study treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"From Baseline through Week 52","groups":[{"id":"OG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"61"},{"groupId":"OG004","value":"61"}]}],"classes":[{"title":"Any AE","categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"49"},{"groupId":"OG004","value":"43"}]}]},{"title":"Any SAE","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Any Hypoglycemic Event","description":"Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.","populationDescription":"Safety Population: all participants who received at least 1 dose of study treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"From Baseline through Week 52","groups":[{"id":"OG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"61"},{"groupId":"OG004","value":"61"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Glycosylated Hemoglobin (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 before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.","populationDescription":"Intent-to-Treat (Last Observation Carried Forward) Population: all enrolled participants who received at least 1 dose of study medication and who had at least one HbA1c post-Baseline assessment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c in the blood","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"61"},{"groupId":"OG004","value":"60"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.04","spread":"0.657"},{"groupId":"OG001","value":"-0.94","spread":"0.623"},{"groupId":"OG002","value":"-0.95","spread":"0.836"},{"groupId":"OG003","value":"-1.42","spread":"0.771"},{"groupId":"OG004","value":"-1.39","spread":"0.770"}]}]}]},{"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. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as \\<6.5% and \\<7.0%.","populationDescription":"Intent-to-Treat (Last Observation Carried Forward) Population","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"61"},{"groupId":"OG004","value":"60"}]}],"classes":[{"title":"HbA1c <6.5%","categories":[{"measurements":[{"groupId":"OG000","value":"20.0"},{"groupId":"OG001","value":"26.9"},{"groupId":"OG002","value":"24.6"},{"groupId":"OG003","value":"45.9"},{"groupId":"OG004","value":"26.2"}]}]},{"title":"HbA1c <7.0%","categories":[{"measurements":[{"groupId":"OG000","value":"54.2"},{"groupId":"OG001","value":"59.7"},{"groupId":"OG002","value":"52.3"},{"groupId":"OG003","value":"80.3"},{"groupId":"OG004","value":"67.2"}]}]}]},{"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 before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.","populationDescription":"Intent-to-Treat (Last Observation Carried Forward) Population. Only those participants with valid post-Baseline results (within 14 days of last exposure to treatment) were analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Milligrams per deciliter (mg/dL)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"61"},{"groupId":"OG004","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.4","spread":"28.52"},{"groupId":"OG001","value":"-24.3","spread":"19.98"},{"groupId":"OG002","value":"-16.4","spread":"30.37"},{"groupId":"OG003","value":"-32.1","spread":"27.21"},{"groupId":"OG004","value":"-33.2","spread":"28.38"}]}]}]},{"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. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.","populationDescription":"Intent-to-Treat (Last Observation Carried Forward) Population","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms (kg)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"61"},{"groupId":"OG004","value":"60"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.25","spread":"2.167"},{"groupId":"OG001","value":"-0.33","spread":"2.082"},{"groupId":"OG002","value":"-0.04","spread":"2.405"},{"groupId":"OG003","value":"0.52","spread":"2.823"},{"groupId":"OG004","value":"-0.13","spread":"2.620"}]}]}]},{"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 \\>=280 mg/dL (\\>=15.5 mmol/L) from \\>=Week 2 to \\<Week 12 or \\>=230 mg/dL (\\>=12.8 mmol/L) from \\>=Week 12 to \\<Week 52.","populationDescription":"Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Weeks","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Albiglutide Plus (+) Background OAD (Sulfonylurea)","description":"Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG001","title":"Albiglutide Plus (+) Background OAD (Biguanide)","description":"Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG002","title":"Albiglutide Plus (+) Background OAD (Glinide)","description":"Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG003","title":"Albiglutide Plus (+) Background OAD (Thiazolidinedione)","description":"Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52."},{"id":"OG004","title":"Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)","description":"Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 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