{"protocolSection":{"identificationModule":{"nctId":"NCT00849017","orgStudyIdInfo":{"id":"112756"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"Safety and Efficacy Study of Albiglutide in Type 2 Diabetes","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2016-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-01"},"primaryCompletionDateStruct":{"date":"2011-11","type":"ACTUAL"},"completionDateStruct":{"date":"2013-02","type":"ACTUAL"},"studyFirstSubmitDate":"2009-02-19","studyFirstSubmitQcDate":"2009-02-19","studyFirstPostDateStruct":{"date":"2009-02-23","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-04-24","resultsFirstSubmitQcDate":"2014-05-29","resultsFirstPostDateStruct":{"date":"2014-06-05","type":"ESTIMATED"},"dispFirstSubmitDate":"2012-06-21","dispFirstSubmitQcDate":"2012-06-21","dispFirstPostDateStruct":{"date":"2012-07-02","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-11-18","lastUpdatePostDateStruct":{"date":"2017-01-09","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"GlaxoSmithKline","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["placebo","albiglutide","monotherapy","diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":309,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"albiglutide","type":"EXPERIMENTAL","description":"albiglutide weekly injection","interventionNames":["Biological: albiglutide"]},{"label":"placebo","type":"PLACEBO_COMPARATOR","description":"albiglutide matching placebo","interventionNames":["Biological: placebo"]},{"label":"albiglutide up-titration","type":"EXPERIMENTAL","description":"albiglutide weekly injection uptitration at week 12","interventionNames":["Biological: albiglutide uptitration"]}],"interventions":[{"type":"BIOLOGICAL","name":"albiglutide","description":"albiglutide weekly injection","armGroupLabels":["albiglutide"]},{"type":"BIOLOGICAL","name":"albiglutide uptitration","description":"albiglutide uptitration at week 12","armGroupLabels":["albiglutide up-titration"]},{"type":"BIOLOGICAL","name":"placebo","description":"matching albiglutide placebo weekly injection","armGroupLabels":["placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52","description":"Glycated hemoglobin (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 BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.","timeFrame":"Baseline and Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c at Weeks 104 and 156","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. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","timeFrame":"Baseline and Weeks 104 and 156"},{"measure":"Time to Hyperglycemia Rescue","description":"Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG \\>=280 milligrams/deciliter (mg/dL) between \\>=Week 2 and \\<Week 4; FPG \\>=250 mg/dL between \\>=Week 4 and \\<Week 12; HbA1c \\>=8.5% and a \\<=0.5% reduction from Baseline between \\>=Week 12 and \\<Week 24; HbA1c \\>=8.5% between \\>=Week 24 and \\<Week 48; HbA1c \\>=8.0% between \\>= Week 48 and \\<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.","timeFrame":"From the start of study medication until the end of the treatment (up to Week 156)"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52","description":"The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156","description":"The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.","timeFrame":"Baseline and Week 156"},{"measure":"Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52","description":"The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 52) were assessed.","timeFrame":"Week 52"},{"measure":"Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156","description":"The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 156) were assessed.","timeFrame":"Week 156"},{"measure":"Change From Baseline in Body Weight at Week 52","description":"The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in Body Weight at Week 156","description":"The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.","timeFrame":"Baseline and Week 156"},{"measure":"Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC","description":"Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC","description":"Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC","description":"Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","timeFrame":"Baseline and Week 52"},{"measure":"Albiglutide Plasma Concentration at Weeks 8 and 24","description":"Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.","timeFrame":"Weeks 8 and 24"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* type 2 diabetes\n* BMI 20-45kg/m2 inclusive\n\nExclusion Criteria:\n\n* females who are pregnant, lactating, or \\<6 weeks post-partum\n* CHF NYHA class III-IV","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"GSK Clinical Trials","affiliation":"GlaxoSmithKline","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"GSK Investigational Site","city":"Alabaster","state":"Alabama","zip":"35007","country":"United States","geoPoint":{"lat":33.24428,"lon":-86.81638}},{"facility":"GSK Investigational 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Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15."},{"pmid":"26577795","type":"DERIVED","citation":"Nauck MA, Stewart MW, Perkins C, Jones-Leone A, Yang F, Perry C, Reinhardt RR, Rendell M. Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetologia. 2016 Feb;59(2):266-74. doi: 10.1007/s00125-015-3795-1. Epub 2015 Nov 17."},{"pmid":"25387217","type":"DERIVED","citation":"Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836."},{"pmid":"24918790","type":"DERIVED","citation":"Young MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med. 2014 May;126(3):35-46. doi: 10.3810/pgm.2014.05.2754."}],"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":"112756","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":"112756","type":"Dataset Specification","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"112756","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":"112756","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":"112756","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":"112756","type":"Study Protocol","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"112756","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":"Participants (par.) who met eligibility criteria and completed a 4 week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. 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Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 156","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Albiglutide 30 mg","description":"Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide 50 mg","description":"Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"32"}]}],"classes":[{"title":"Week 156, HbA1c <6.5%","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"11"}]}]},{"title":"Week 156, HbA1c <7.0%","categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"19"}]}]},{"title":"Week 156, HbA1c <7.5%","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"29"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 52","description":"The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.","populationDescription":"ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilograms","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Albiglutide 30 mg","description":"Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide 50 mg","description":"Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.66","spread":"0.428"},{"groupId":"OG001","value":"-0.39","spread":"0.424"},{"groupId":"OG002","value":"-0.86","spread":"0.432"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 156","description":"The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.","populationDescription":"ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline and Week 156","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Albiglutide 30 mg","description":"Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide 50 mg","description":"Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"31"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.91","spread":"5.213"},{"groupId":"OG001","value":"-1.32","spread":"5.123"},{"groupId":"OG002","value":"-2.24","spread":"5.589"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC","description":"Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","populationDescription":"MM Population: all participants who participated in the MM tolerance test substudy and who had valid Baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of C-peptide.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Nanomoles/Liter (nmol/L)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Albiglutide 30 mg Weekly","description":"Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide 50 mg Weekly","description":"Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.05","spread":"0.165"},{"groupId":"OG001","value":"0.03","spread":"0.122"},{"groupId":"OG002","value":"0.08","spread":"0.108"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC","description":"Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","populationDescription":"MM Population: all participants who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of glucose. The MM tolerance test was performed only in those participants who additionally consented to participate in.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Nanomoles/Liter (nmol/L)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Albiglutide 30 mg","description":"Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide 50 mg","description":"Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"19"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.51","spread":"0.630"},{"groupId":"OG001","value":"-1.74","spread":"0.414"},{"groupId":"OG002","value":"-2.05","spread":"0.407"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC","description":"Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","populationDescription":"MM Population: all participant who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameters of insulin, proinsulin. The MM tolerance test was performed only in those participants who additionally consented to participate in.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"picomoles/Liter (pmol/L)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Albiglutide 30 mg","description":"Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide 50 mg","description":"Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"20"}]}],"classes":[{"title":"4hr Ins AUC","categories":[{"measurements":[{"groupId":"OG000","value":"49.2","spread":"50.12"},{"groupId":"OG001","value":"2.9","spread":"36.44"},{"groupId":"OG002","value":"39.9","spread":"32.62"}]}]},{"title":"4hr Pro-Ins AUC","categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"17.57"},{"groupId":"OG001","value":"1.9","spread":"13.25"},{"groupId":"OG002","value":"-10.7","spread":"11.62"}]}]}]},{"type":"SECONDARY","title":"Albiglutide Plasma Concentration at Weeks 8 and 24","description":"Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.","populationDescription":"ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms/milliliter (ng/mL)","timeFrame":"Weeks 8 and 24","groups":[{"id":"OG000","title":"Albiglutide 30 mg","description":"Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Albiglutide 50 mg","description":"Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"85"}]}],"classes":[{"title":"Week 8 Pre-dose, n=85, 85","categories":[{"measurements":[{"groupId":"OG000","value":"1582","spread":"735"},{"groupId":"OG001","value":"1433","spread":"736"}]}]},{"title":"Week 8 Post-dose, n=87, 80","categories":[{"measurements":[{"groupId":"OG000","value":"1900","spread":"1093"},{"groupId":"OG001","value":"1759","spread":"861"}]}]},{"title":"Week 24 Pre-dose, n=79, 74","categories":[{"measurements":[{"groupId":"OG000","value":"1912","spread":"966"},{"groupId":"OG001","value":"3060","spread":"1610"}]}]},{"title":"Week 24 Post-dose, n=81, 72","categories":[{"measurements":[{"groupId":"OG000","value":"2289","spread":"1255"},{"groupId":"OG001","value":"3484","spread":"2301"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.","description":"SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.","seriousNumAffected":16,"seriousNumAtRisk":101,"otherNumAffected":78,"otherNumAtRisk":101},{"id":"EG001","title":"Albiglutide 30 mg","description":"Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.","seriousNumAffected":15,"seriousNumAtRisk":101,"otherNumAffected":84,"otherNumAtRisk":101},{"id":"EG002","title":"Albiglutide 50 mg","description":"Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.","seriousNumAffected":14,"seriousNumAtRisk":99,"otherNumAffected":83,"otherNumAtRisk":99}],"seriousEvents":[{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"B-cell lymphoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Bladder cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Colon cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Endometrial cancer stage I","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":1,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Hodgkin's disease","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Lung adenocarcinoma metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Malignant melanoma in situ","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Neuroendocrine tumour","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Pancreatic carcinoma metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Prostate 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disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":1,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Cardiomyopathy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":1,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Congestive cardiomyopathy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":1,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Left ventricular dysfunction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Mitral valve incompetence","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Pericardial effusion","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":101},{"groupId":"EG001","numAffected":2,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Carpal tunnel syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":1,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Cerebral infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":1,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Convulsion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":1,"numAtRisk":101},{"groupId":"EG002","numAffected":0,"numAtRisk":99}]},{"term":"Ischemic stroke","organSystem":"Nervous system 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disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":1,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Drowning","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Cellulitis staphylococcal","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Diabetic foot infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Lobar pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":101},{"groupId":"EG001","numAffected":0,"numAtRisk":101},{"groupId":"EG002","numAffected":1,"numAtRisk":99}]},{"term":"Pneumonia","organSystem":"Infections and 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