{"protocolSection":{"identificationModule":{"nctId":"NCT01357889","orgStudyIdInfo":{"id":"114856"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"Pharmacokinetics/Pharmacodynamics of Albiglutide","officialTitle":"A Multidose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Pharmacokinetics and Pharmacodynamics of Albiglutide"},"statusModule":{"statusVerifiedDate":"2016-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-07"},"primaryCompletionDateStruct":{"date":"2012-10","type":"ACTUAL"},"completionDateStruct":{"date":"2012-10","type":"ACTUAL"},"studyFirstSubmitDate":"2011-05-19","studyFirstSubmitQcDate":"2011-05-19","studyFirstPostDateStruct":{"date":"2011-05-23","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-04-24","resultsFirstSubmitQcDate":"2014-04-24","resultsFirstPostDateStruct":{"date":"2014-05-23","type":"ESTIMATED"},"dispFirstSubmitDate":"2013-05-02","dispFirstSubmitQcDate":"2013-05-02","dispFirstPostDateStruct":{"date":"2013-05-09","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 first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.","detailedDescription":"This is a randomized, double-blind, multicenter, 2 parallel group study. The first part of the treatment period will evaluate the pharmacokinetic bioequivalence of a single dose of a subcutaneous injection of 30mg of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, effects on glycosylated hemoglobin and fasting plasma glucose, and safety and tolerability of repeat doses of subcutaneous injections of 30mg of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["pharmacokinetics","pharmacodynamics","GSK716155","albiglutide"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":283,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"process 2 albiglutide","type":"ACTIVE_COMPARATOR","description":"albiglutide 30mg from process 2 drug substance","interventionNames":["Biological: albiglutide (GSK716155)"]},{"label":"process 3 albiglutide","type":"ACTIVE_COMPARATOR","description":"albiglutide 30mg from process 3 drug substance","interventionNames":["Biological: albiglutide (GSK716155)"]}],"interventions":[{"type":"BIOLOGICAL","name":"albiglutide (GSK716155)","description":"subcutaneous injection administered once a week","armGroupLabels":["process 2 albiglutide"],"otherNames":["process 2"]},{"type":"BIOLOGICAL","name":"albiglutide (GSK716155)","description":"subcutaneous injection administered once a week","armGroupLabels":["process 3 albiglutide"],"otherNames":["process 3"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase","description":"To assess the bioequivalence of the two formulations of albiglutide, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter AUC(0-inf) estimated from the BE Phase. AUC is a measure of how much albiglutide is in the blood at certain time points. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","timeFrame":"Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose"},{"measure":"Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase","description":"To assess the bioequivalence of the two formulations of study drug, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter Cmax estimated from the BE phase. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose"}],"secondaryOutcomes":[{"measure":"Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)","description":"The trough concentration of albiglutide at Week 5, Week 9, Week 13, Week 17 (EOT), and Week 25 (Follow-up) following multiple-dose administration was estimated. The time and date of sample collection pre-dose was to be recorded.","timeFrame":"Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)"},{"measure":"Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase","description":"The presence of anti-albiglutide antibodies after repeat-dose administration was assessed using a qualified enzyme-linked immunosorbent assay. The assay involved screening, confirmation, and titration steps (tiered-testing approach). The number of participants who tested positive for anti-albiglutide antibodies are presented by visit.","timeFrame":"Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)"},{"measure":"AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase","description":"The area under the concentration-time (AUC) curve from time zero to the last quantifiable concentration (0-last) and AUC (0-inf) of albiglutide in the BE Phase were measured. AUC is a measure of how much albiglutide is in the blood at certain time points. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose"},{"measure":"Tmax and Tlag of Albiglutide in the BE Phase","description":"Time of the maximum observed plasma concentration (tmax) and the observed time prior to the first quantifiable plasma concentration (tlag) of albiglutide in the BE Phase were measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose"},{"measure":"Cmax of Albiglutide in the BE Phase","description":"Cmax of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose"},{"measure":"t1/2 of Albiglutide in the BE Phase","description":"The terminal elimination half-life (t1/2) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose"},{"measure":"Apparent Clearance of Albiglutide in the BE Phase","description":"The apparent clearance (CL/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose"},{"measure":"Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase","description":"The apparent volume of distribution in the terminal phase (V/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose"},{"measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. This analysis used the last observation carried forward (LOCF) method for missing post-Baseline HbA1c values. HbA1c values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on analysis of covariance (ANCOVA): Change = treatment + Baseline HbA1c + age category + weight category + background antidiabetic therapy category.","timeFrame":"Baseline and Week 17"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17","description":"This analysis used the LOCF method for missing post-Baseline FPG values. FPG values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on ANCOVA: Change = treatment + Baseline FPG + age category + weight category + background antidiabetic therapy category.","timeFrame":"Baseline and Week 17"},{"measure":"Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)","description":"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the 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, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Hypoglycemic events are excluded from this table, except for serious adverse events.","timeFrame":"From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study"},{"measure":"Number of Participants With Indicated Adverse Events of Special Interest","description":"Adverse events of special interest included cardiovascular events, hypoglycemic events, pancreatitis events, thyroid events, gastrointestinal (GI) events, diabetic retinopathy events, systemic allergic reactions (SAR), injection site reactions (ISR), and liver events (AEs from investigations and hepatobiliary disorders were considered).","timeFrame":"From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study"},{"measure":"Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit","description":"Criteria for values of potential concern were determined by the medical monitors. For hematocrit, a \\>0.1 decrease from Baseline was considered to be of clinical concern. For hemoglobin, a \\>25 grams per liter (g/L) decrease from Baseline was considered to be of clinical concern.","timeFrame":"Week 1 through Week 25"},{"measure":"Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit","description":"Vital signs measured included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Criteria for values of potential concern were determined by the medical monitors. For SBP, a decrease or increase \\>30 millimeters of mercury (mmHg) from Baseline was considered to be of clinical concern. For DBP, a decrease or increase \\>20 mmHg from Baseline was considered to be of clinical concern. For heart rate, a decrease or increase \\>30 beats per minute (bpm) was considered to be of clinical concern.","timeFrame":"Week 1 through Week 25"},{"measure":"Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17","description":"A complete physical examination was performed at Screening and at Week 17 and included evaluation of the following organ or body systems: skin (including injection site); head; eyes; ears, sose, and throat (ENT); thyroid; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; central nervous system (CNT); and extremities. The assessment was categorized as improved, no change, worsened, and not done.","timeFrame":"Screening and Week 17"},{"measure":"Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit","description":"ECG parameters include heart rate, QRS interval, QTinterval, QT interval - Bazett correction (QTcB), QT interval - Fridericia correction (QTcF), RR interval, and PR interval. Criteria for values of potential concern were determined by the medical monitors. For the QRS interval, an increase of \\>25% when Baseline QRS \\>100 milliseconds (msec) and an increase of \\>50% when Baseline QRS \\<=100 msec was considered to be of clinical concern. For QTcF, a \\>=60 msec change from Baseline was considered to be of clinical concern. For the PR interval, an increase of \\>25% when Baseline PR \\>200 msec and an increase of \\>50% when Baseline PR \\<=200 msec was considered to be of clinical concern.","timeFrame":"Week 1 through Week 25"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Subjects with a historical diagnosis of type 2 diabetes mellitus who are experiencing inadequate glycemic control on their current regimen of diet and exercise or on a stable dose of metformin\n* Body mass index ≥20 kg/m2 and ≤45 kg/m2\n* Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)\n* Thyroid-stimulating hormone level is normal or clinically euthyroid\n* Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception.\n\nExclusion Criteria:\n\n* Current ongoing symptomatic biliary disease or history of pancreatitis\n* History of significant GI surgery\n* Recent clinically significant cardiovascular and/or cerebrovascular disease\n* History of human immunodeficiency virus infection\n* History of, or current hepatic disease\n* History of alcohol or substance abuse\n* Female subject is pregnant, lactating, or \\<6 weeks postpartum\n* History of type 1 diabetes\n* Receipt of any investigational drug within the 30 days, or 5 half-lives whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of any GLP-1 agents including albiglutide\n* History of, or family history of thyroid disease","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"GSK Clinical Trials","affiliation":"GlaxoSmithKline","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"GSK Investigational Site","city":"Dothan","state":"Alabama","zip":"36301","country":"United States","geoPoint":{"lat":31.22323,"lon":-85.39049}},{"facility":"GSK Investigational Site","city":"Long Beach","state":"California","zip":"90806","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"GSK Investigational Site","city":"Riverside","state":"California","zip":"92506","country":"United States","geoPoint":{"lat":33.95335,"lon":-117.39616}},{"facility":"GSK Investigational Site","city":"Hallandale","state":"Florida","zip":"33009","country":"United States","geoPoint":{"lat":25.9812,"lon":-80.14838}},{"facility":"GSK Investigational Site","city":"Jacksonville","state":"Florida","zip":"32205","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"GSK Investigational Site","city":"Orlando","state":"Florida","zip":"32822","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"GSK Investigational Site","city":"Tampa","state":"Florida","zip":"33603","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"GSK Investigational Site","city":"Blue Ridge","state":"Georgia","zip":"30513","country":"United States","geoPoint":{"lat":34.86397,"lon":-84.32409}},{"facility":"GSK Investigational Site","city":"Lexington","state":"Kentucky","zip":"40504","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"GSK Investigational Site","city":"Paducah","state":"Kentucky","zip":"42003","country":"United States","geoPoint":{"lat":37.08339,"lon":-88.60005}},{"facility":"GSK Investigational Site","city":"Gulfport","state":"Mississippi","zip":"39501","country":"United States","geoPoint":{"lat":30.36742,"lon":-89.09282}},{"facility":"GSK Investigational Site","city":"Picayune","state":"Mississippi","zip":"39466","country":"United States","geoPoint":{"lat":30.52556,"lon":-89.67788}},{"facility":"GSK Investigational Site","city":"Omaha","state":"Nebraska","zip":"68131","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"GSK Investigational Site","city":"Greensboro","state":"North Carolina","zip":"27405","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"GSK Investigational Site","city":"Columbus","state":"Ohio","zip":"43213","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"GSK Investigational Site","city":"Mason","state":"Ohio","zip":"45040","country":"United States","geoPoint":{"lat":39.36006,"lon":-84.30994}},{"facility":"GSK Investigational Site","city":"Bensalem","state":"Pennsylvania","zip":"19020","country":"United States","geoPoint":{"lat":40.10455,"lon":-74.95128}},{"facility":"GSK Investigational Site","city":"Columbia","state":"South Carolina","zip":"29201","country":"United States","geoPoint":{"lat":34.00071,"lon":-81.03481}},{"facility":"GSK Investigational Site","city":"North Myrtle Beach","state":"South Carolina","zip":"29582","country":"United States","geoPoint":{"lat":33.81601,"lon":-78.68002}},{"facility":"GSK Investigational Site","city":"Simpsonville","state":"South Carolina","zip":"29681","country":"United States","geoPoint":{"lat":34.73706,"lon":-82.25428}},{"facility":"GSK Investigational Site","city":"Clarksville","state":"Tennessee","zip":"37043","country":"United States","geoPoint":{"lat":36.52977,"lon":-87.35945}},{"facility":"GSK Investigational Site","city":"McKenzie","state":"Tennessee","zip":"38201","country":"United States","geoPoint":{"lat":36.13256,"lon":-88.51866}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77074","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Irving","state":"Texas","zip":"75039","country":"United States","geoPoint":{"lat":32.81402,"lon":-96.94889}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78215","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78218","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"Sugarland","state":"Texas","zip":"77479","country":"United States"},{"facility":"GSK Investigational Site","city":"Bountiful","state":"Utah","zip":"84010","country":"United States","geoPoint":{"lat":40.88939,"lon":-111.88077}},{"facility":"GSK Investigational Site","city":"Lewisburg","state":"West Virginia","zip":"24901","country":"United States","geoPoint":{"lat":37.80179,"lon":-80.44563}}]},"referencesModule":{"references":[{"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."}],"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":"114856","type":"Dataset Specification","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"114856","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":"114856","type":"Statistical Analysis Plan","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"114856","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":"114856","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":"114856","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":"114856","type":"Study Protocol","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":"This study was comprised of a Screening Period (up to 2 weeks), a Run-in Period (4 weeks), a Treatment Period (TP: 17 weeks), and a Follow-up (8 weeks) Period. The TP had a Single-dose Phase (Bioequivalence \\[BE\\] Phase: 28 days) and a 12-week Multiple-dose Phase. In the BE Phase, 186 participants were randomized; 167 received \\>=1 treatment dose.","recruitmentDetails":"The enrollment number reflects the 283 participants starting the Multiple-dose Phase.","groups":[{"id":"FG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"FG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"periods":[{"title":"Single-dose Phase (BE Phase: 28 Days)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"86"},{"groupId":"FG001","numSubjects":"81"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"82"},{"groupId":"FG001","numSubjects":"79"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Persistent Hyperglycemia","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Multiple-dose Phase (MDP) (Overall)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"After completion of the BE Phase, additional participants were randomized to the Overall Phase.","numSubjects":"141"},{"groupId":"FG001","comment":"After completion of the BE Phase, additional participants were randomized to the Overall Phase.","numSubjects":"142"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"125"},{"groupId":"FG001","numSubjects":"126"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Noncompliance","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawn Due to Hyperglycemia","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]}]},{"title":"Follow-up Phase (FUP) (8 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"All participants who started the MDP entered the FUP, regardless of MDP completion status.","numSubjects":"141"},{"groupId":"FG001","comment":"All participants who started the MDP entered the FUP, regardless of MDP completion status.","numSubjects":"142"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"138"},{"groupId":"FG001","numSubjects":"138"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Noncompliance","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Hyperglycemia","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"BG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"141"},{"groupId":"BG001","value":"142"},{"groupId":"BG002","value":"283"}]}],"measures":[{"title":"Age, Continuous","description":"Baseline data are reported for participants randomized to the Single- and Multiple-dose Phases (Overall).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"52.6","spread":"11.18"},{"groupId":"BG001","value":"54.4","spread":"10.53"},{"groupId":"BG002","value":"53.5","spread":"10.88"}]}]}]},{"title":"Gender","description":"Baseline data are reported for participants randomized to the Single- and Multiple-dose Phases (Overall).","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"154"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"66"},{"groupId":"BG002","value":"129"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"Baseline data are reported for participants randomized to the Single- and Multiple-dose Phases (Overall).","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"African American/African Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"35"}]}]},{"title":"American Indian or Alaskan Native","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]},{"title":"Asian - Central/South Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]}]},{"title":"Asian - East Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]},{"title":"Asian - South East Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]}]},{"title":"Native Hawaiian or Other Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]},{"title":"White - White/Caucasian/European Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"117"},{"groupId":"BG002","value":"237"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"SECONDARY","title":"Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)","description":"The trough concentration of albiglutide at Week 5, Week 9, Week 13, Week 17 (EOT), and Week 25 (Follow-up) following multiple-dose administration was estimated. The time and date of sample collection pre-dose was to be recorded.","populationDescription":"PK Concentration Population (PKCP): participants (par.) in the MDP for whom a PK sample was collected/analyzed. Only par. available at the specified time points were analyzed (n= X, X in the category titles). Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PKCP.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"138"}]}],"classes":[{"title":"Week 5, n=131, 135","categories":[{"measurements":[{"groupId":"OG000","value":"10.55","spread":"34.847"},{"groupId":"OG001","value":"8.70","spread":"25.547"}]}]},{"title":"Week 9, n=127, 130","categories":[{"measurements":[{"groupId":"OG000","value":"2420.95","spread":"1064.204"},{"groupId":"OG001","value":"2519.62","spread":"911.794"}]}]},{"title":"Week 13, n=126, 127","categories":[{"measurements":[{"groupId":"OG000","value":"2352.94","spread":"984.488"},{"groupId":"OG001","value":"2356.27","spread":"987.143"}]}]},{"title":"Week 17 (EOT), n=123, 125","categories":[{"measurements":[{"groupId":"OG000","value":"2360.19","spread":"1005.598"},{"groupId":"OG001","value":"2436.63","spread":"1089.381"}]}]},{"title":"Week 25 (follow-up), n=121, 123","categories":[{"measurements":[{"groupId":"OG000","value":"28.20","spread":"291.287"},{"groupId":"OG001","value":"14.45","spread":"160.245"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase","description":"The presence of anti-albiglutide antibodies after repeat-dose administration was assessed using a qualified enzyme-linked immunosorbent assay. The assay involved screening, confirmation, and titration steps (tiered-testing approach). The number of participants who tested positive for anti-albiglutide antibodies are presented by visit.","populationDescription":"Safety Population: all par. who received at least 1 dose of study medication. Only those par. available at the specified time points were analyzed (represented by n= X, X in the category titles). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Safety Population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"142"}]}],"classes":[{"title":"Baseline, n=139, 140","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 5, n=131, 132","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 9, n=124, 120","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 13, n=119, 122","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}]},{"title":"Week 17, n=119, 127","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"5"}]}]},{"title":"Week 25, n=116, 118","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase","description":"The area under the concentration-time (AUC) curve from time zero to the last quantifiable concentration (0-last) and AUC (0-inf) of albiglutide in the BE Phase were measured. AUC is a measure of how much albiglutide is in the blood at certain time points. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","populationDescription":"Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PK Population.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms*hour/milliliter","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"80"}]}],"classes":[{"title":"AUC (0-last), n=84, 80","categories":[{"measurements":[{"groupId":"OG000","value":"447294.0","spread":"55.5"},{"groupId":"OG001","value":"426263.5","spread":"45.2"}]}]},{"title":"AUC (0-inf), n=75, 74","categories":[{"measurements":[{"groupId":"OG000","value":"496190.2","spread":"41.8"},{"groupId":"OG001","value":"464985.4","spread":"39.7"}]}]}]},{"type":"SECONDARY","title":"Tmax and Tlag of Albiglutide in the BE Phase","description":"Time of the maximum observed plasma concentration (tmax) and the observed time prior to the first quantifiable plasma concentration (tlag) of albiglutide in the BE Phase were measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","populationDescription":"Albiglutide PK Population. Participants with insufficient concentration data or terminal elimination rate constant not estimable were excluded.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Hours","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"80"}]}],"classes":[{"title":"tmax, n=85, 80","categories":[{"measurements":[{"groupId":"OG000","value":"95.50","lowerLimit":"23.4","upperLimit":"214.3"},{"groupId":"OG001","value":"96.08","lowerLimit":"20.5","upperLimit":"217.8"}]}]},{"title":"tlag, n=84, 80","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","lowerLimit":"0.0","upperLimit":"24.1"},{"groupId":"OG001","value":"0.00","lowerLimit":"0.0","upperLimit":"24.1"}]}]}]},{"type":"SECONDARY","title":"Cmax of Albiglutide in the BE Phase","description":"Cmax of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","populationDescription":"Albiglutide PK Population","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1881.05","spread":"58.3"},{"groupId":"OG001","value":"1743.05","spread":"49.1"}]}]}]},{"type":"SECONDARY","title":"t1/2 of Albiglutide in the BE Phase","description":"The terminal elimination half-life (t1/2) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","populationDescription":"Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Hours","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"106.42","spread":"16.3"},{"groupId":"OG001","value":"113.83","spread":"22.5"}]}]}]},{"type":"SECONDARY","title":"Apparent Clearance of Albiglutide in the BE Phase","description":"The apparent clearance (CL/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","populationDescription":"Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Liters per hour","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.06046","spread":"41.8"},{"groupId":"OG001","value":"0.06452","spread":"39.7"}]}]}]},{"type":"SECONDARY","title":"Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase","description":"The apparent volume of distribution in the terminal phase (V/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","populationDescription":"Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Liters","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.283","spread":"44.0"},{"groupId":"OG001","value":"10.595","spread":"44.3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. This analysis used the last observation carried forward (LOCF) method for missing post-Baseline HbA1c values. HbA1c values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on analysis of covariance (ANCOVA): Change = treatment + Baseline HbA1c + age category + weight category + background antidiabetic therapy category.","populationDescription":"Efficacy Population - LOCF: all participants who received a dose of study medication and who had a Baseline measurement and at least 1 post-Baseline HbA1c or fasting plasma glucose (FPG) measurement. Only participants available at the specified time point were analyzed.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c in blood","timeFrame":"Baseline and Week 17","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"135"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.75","spread":"0.082"},{"groupId":"OG001","value":"-0.84","spread":"0.082"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17","description":"This analysis used the LOCF method for missing post-Baseline FPG values. FPG values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on ANCOVA: Change = treatment + Baseline FPG + age category + weight category + background antidiabetic therapy category.","populationDescription":"Efficacy Population - LOCF","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per liter","timeFrame":"Baseline and Week 17","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.11","spread":"0.231"},{"groupId":"OG001","value":"-1.21","spread":"0.231"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)","description":"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the 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, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Hypoglycemic events are excluded from this table, except for serious adverse events.","populationDescription":"Safety Population","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"142"}]}],"classes":[{"title":"Any AE","categories":[{"measurements":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"91"}]}]},{"title":"Any SAE","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Indicated Adverse Events of Special Interest","description":"Adverse events of special interest included cardiovascular events, hypoglycemic events, pancreatitis events, thyroid events, gastrointestinal (GI) events, diabetic retinopathy events, systemic allergic reactions (SAR), injection site reactions (ISR), and liver events (AEs from investigations and hepatobiliary disorders were considered).","populationDescription":"Safety Population","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"142"}]}],"classes":[{"title":"Any cardiovascular AE","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"9"}]}]},{"title":"Any hypoglycemic AE","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"7"}]}]},{"title":"Any thyroid AE","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]},{"title":"Any GI AE","categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"32"}]}]},{"title":"Any SAR AE","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Any ISR AE","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"7"}]}]},{"title":"Any hepatobiliary AE","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}]},{"title":"Any investigations","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"10"}]}]},{"title":"Any pancreatitis AE","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Any diabetic retinopathy AE","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit","description":"Criteria for values of potential concern were determined by the medical monitors. For hematocrit, a \\>0.1 decrease from Baseline was considered to be of clinical concern. For hemoglobin, a \\>25 grams per liter (g/L) decrease from Baseline was considered to be of clinical concern.","populationDescription":"Safety Population. Only those participants available at the specified time points were analyzed.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 1 through Week 25","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"140"}]}],"classes":[{"title":"Hematocrit >0.1 decrease","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Hemoglobin >25 g/L","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit","description":"Vital signs measured included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Criteria for values of potential concern were determined by the medical monitors. For SBP, a decrease or increase \\>30 millimeters of mercury (mmHg) from Baseline was considered to be of clinical concern. For DBP, a decrease or increase \\>20 mmHg from Baseline was considered to be of clinical concern. For heart rate, a decrease or increase \\>30 beats per minute (bpm) was considered to be of clinical concern.","populationDescription":"Safety Population. Only those participants available at the specified time points were analyzed.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 1 through Week 25","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"141"}]}],"classes":[{"title":"SBP, decrease >30 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"16"}]}]},{"title":"SBP, increase >30 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}]},{"title":"DBP, decrease >20 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"16"}]}]},{"title":"DBP, increase >20 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}]},{"title":"Heart rate, decrease >30 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"}]}]},{"title":"Heart rate, increase >30 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17","description":"A complete physical examination was performed at Screening and at Week 17 and included evaluation of the following organ or body systems: skin (including injection site); head; eyes; ears, sose, and throat (ENT); thyroid; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; central nervous system (CNT); and extremities. The assessment was categorized as improved, no change, worsened, and not done.","populationDescription":"Safety Population. Only participants analyzed at Week 17 are presented.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Screening and Week 17","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"125"}]}],"classes":[{"title":"Skin, Improved","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}]},{"title":"Skin, No Change","categories":[{"measurements":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"117"}]}]},{"title":"Skin, Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"}]}]},{"title":"Skin, Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Head, Eyes, ENT, Improved","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}]},{"title":"Head, Eyes, ENT, No Change","categories":[{"measurements":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"122"}]}]},{"title":"Head, Eyes, ENT, Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}]},{"title":"Head, Eyes, ENT, Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Cardiovascular system, Improved","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Cardiovascular system, No Change","categories":[{"measurements":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"124"}]}]},{"title":"Cardiovascular system, Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Cardiovascular system, Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Respiratory system, Improved","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Respiratory system, No Change","categories":[{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"123"}]}]},{"title":"Respiratory system, Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Respiratory system, Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Abdomen (Liver and Spleen), Improved","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Abdomen (Liver and Spleen), No Change","categories":[{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"121"}]}]},{"title":"Abdomen (Liver and Spleen), Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}]},{"title":"Abdomen (Liver and Spleen), Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Lymph Nodes, Improved","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Lymph Nodes, No Change","categories":[{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"123"}]}]},{"title":"Lymph Nodes, Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Lymph Nodes, Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]},{"title":"CNS, Improved","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]},{"title":"CNS, No Change","categories":[{"measurements":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"122"}]}]},{"title":"CNS, Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"CNS, Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Extremities, Improved","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}]}]},{"title":"Extremities, No Change","categories":[{"measurements":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"118"}]}]},{"title":"Extremities, Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}]},{"title":"Extremities, Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]},{"title":"Thyroid, Improved","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Thyroid, No Change","categories":[{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"123"}]}]},{"title":"Thyroid, Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Thyroid, Not done","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit","description":"ECG parameters include heart rate, QRS interval, QTinterval, QT interval - Bazett correction (QTcB), QT interval - Fridericia correction (QTcF), RR interval, and PR interval. Criteria for values of potential concern were determined by the medical monitors. For the QRS interval, an increase of \\>25% when Baseline QRS \\>100 milliseconds (msec) and an increase of \\>50% when Baseline QRS \\<=100 msec was considered to be of clinical concern. For QTcF, a \\>=60 msec change from Baseline was considered to be of clinical concern. For the PR interval, an increase of \\>25% when Baseline PR \\>200 msec and an increase of \\>50% when Baseline PR \\<=200 msec was considered to be of clinical concern.","populationDescription":"Safety Population. Only those participants available at the specified time points were analyzed. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the Safety Population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 1 through Week 25","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"142"}]}],"classes":[{"title":"QRS, Increase of > 25% or >50%, n=139, 137","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"QTcF, >=60 msec, n=139, 137","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"PR, Increase of > 25% or >50%, n=137, 135","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"PRIMARY","title":"Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase","description":"To assess the bioequivalence of the two formulations of albiglutide, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter AUC(0-inf) estimated from the BE Phase. AUC is a measure of how much albiglutide is in the blood at certain time points. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","populationDescription":"Albiglutide Pharmacokinetic (PK) Population: all participants who had sufficient samples to calculate PK parameters of albiglutide. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms*hour/milliliter","timeFrame":"Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"496190.200","spread":"42"},{"groupId":"OG001","value":"464985.355","spread":"40"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"To establish BE, the 90% CI for the ratio of Process 3 (P3) to Process 2 (P2) geometric least squares means (LSMs) for AUC (0-inf) must have fallen within the BE limit of 0.8 and 1.25.","statisticalMethod":"ANOVA","paramType":"Ratio of Geometric LSMs (P3:P2)","paramValue":"0.937","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.842","ciUpperLimit":"1.042"}]},{"type":"PRIMARY","title":"Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase","description":"To assess the bioequivalence of the two formulations of study drug, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter Cmax estimated from the BE phase. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.","populationDescription":"Albiglutide PK Population","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms per milliliter (ng/mL)","timeFrame":"Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose","groups":[{"id":"OG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."},{"id":"OG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1881.053","spread":"58"},{"groupId":"OG001","value":"1743.053","spread":"49"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"To establish BE, the 90% CI for the ratio of Process 3:Process 2 geometric least squares means for Cmax must have fallen within the BE limit of 0.8 and 1.25.","statisticalMethod":"ANOVA","paramType":"Ratio of Geometric LSMs (P3:P2)","paramValue":"0.927","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.813","ciUpperLimit":"1.056"}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation.","description":"SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.","eventGroups":[{"id":"EG000","title":"Albiglutide Process 2","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.","seriousNumAffected":5,"seriousNumAtRisk":141,"otherNumAffected":84,"otherNumAtRisk":141},{"id":"EG001","title":"Albiglutide Process 3","description":"During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. 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