Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2026-03-02 @ 4:09 AM
Study NCT ID:
NCT01475734
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2011-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534611', 'term': 'rGLP-1 protein'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs and non-serious AEs were collected from the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 weeks).', 'description': 'On-therapy SAEs and non-serious AEs (onset on or after the first day of study medication) were collected in members of the Safety Population, comprised of all randomly assigned study participants who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.', 'otherNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.', 'otherNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': '0 hr, n=20, 21', 'categories': [{'measurements': [{'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG000'}, {'value': '0.03805', 'spread': '1.030606', 'groupId': 'OG001'}]}]}, {'title': '1 hr, n=20, 21', 'categories': [{'measurements': [{'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG000'}, {'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG001'}]}]}, {'title': '1 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.03783', 'spread': '1.003528', 'groupId': 'OG000'}, {'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG001'}]}]}, {'title': '1 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG000'}, {'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG001'}]}]}, {'title': '2 hr, n=20, 20', 'categories': [{'measurements': [{'value': '0.03805', 'spread': '1.029775', 'groupId': 'OG000'}, {'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG001'}]}]}, {'title': '2 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.03876', 'spread': '1.090802', 'groupId': 'OG000'}, {'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG001'}]}]}, {'title': '3 hr, n=20, 21', 'categories': [{'measurements': [{'value': '0.03808', 'spread': '1.024552', 'groupId': 'OG000'}, {'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG001'}]}]}, {'title': '3 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.04296', 'spread': '1.203416', 'groupId': 'OG000'}, {'value': '0.03922', 'spread': '1.127202', 'groupId': 'OG001'}]}]}, {'title': '3 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.04072', 'spread': '1.146327', 'groupId': 'OG000'}, {'value': '0.03893', 'spread': '1.086818', 'groupId': 'OG001'}]}]}, {'title': '4 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.03976', 'spread': '1.152056', 'groupId': 'OG000'}, {'value': '0.04094', 'spread': '1.192380', 'groupId': 'OG001'}]}]}, {'title': '4 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.03899', 'spread': '1.105904', 'groupId': 'OG000'}, {'value': '0.04000', 'spread': '1.146223', 'groupId': 'OG001'}]}]}, {'title': '4 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.03936', 'spread': '1.102107', 'groupId': 'OG000'}, {'value': '0.03958', 'spread': '1.116342', 'groupId': 'OG001'}]}]}, {'title': '5 hr, n=20, 21', 'categories': [{'measurements': [{'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG000'}, {'value': '0.03814', 'spread': '1.042285', 'groupId': 'OG001'}]}]}, {'title': '5 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.03809', 'spread': '1.034545', 'groupId': 'OG000'}, {'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG001'}]}]}, {'title': '5 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG000'}, {'value': '0.03780', 'spread': '1.000000', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.791', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.993', 'ciLowerLimit': '0.946', 'ciUpperLimit': '1.043', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 0 hr.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.000', 'ciLowerLimit': '0.952', 'ciUpperLimit': '1.050', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.975', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.001', 'ciLowerLimit': '0.953', 'ciUpperLimit': '1.051', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 15 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.000', 'ciLowerLimit': '0.952', 'ciUpperLimit': '1.050', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 45 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.908', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.003', 'ciLowerLimit': '0.955', 'ciUpperLimit': '1.053', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.312', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.025', 'ciLowerLimit': '0.977', 'ciUpperLimit': '1.077', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr 45 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.008', 'ciLowerLimit': '0.960', 'ciUpperLimit': '1.058', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.095', 'ciLowerLimit': '1.043', 'ciUpperLimit': '1.150', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 30 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.046', 'ciLowerLimit': '0.996', 'ciUpperLimit': '1.098', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 45 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.238', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.971', 'ciLowerLimit': '0.925', 'ciUpperLimit': '1.020', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 15 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.298', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.975', 'ciLowerLimit': '0.928', 'ciUpperLimit': '1.023', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 30 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.821', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.994', 'ciLowerLimit': '0.947', 'ciUpperLimit': '1.044', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 45 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.715', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.991', 'ciLowerLimit': '0.944', 'ciUpperLimit': '1.040', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.008', 'ciLowerLimit': '0.960', 'ciUpperLimit': '1.058', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 15 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.000', 'ciLowerLimit': '0.952', 'ciUpperLimit': '1.050', 'estimateComment': 'The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 30 min.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4', 'description': 'Plasma glucagon levels were measured for the estimation of glucagon secretion during the hypoglycemic periods. Glucagon response was measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on non-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification (0.03780 nmol/L) were set to the quantification limit for summary.', 'unitOfMeasure': 'Nanomoles per liter (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Population: all participants who received 1 dose of albiglutide or placebo, had a Baseline assessment, and had at least 1 post-Baseline assessment of the primary endpoint (glucagon) during the clamp procedure. PD Population participants were analyzed according to randomly assigned treatment.'}, {'type': 'SECONDARY', 'title': 'Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': '1 hr', 'categories': [{'measurements': [{'value': '0.22992', 'spread': '0.175853', 'groupId': 'OG000'}, {'value': '0.15487', 'spread': '0.111490', 'groupId': 'OG001'}]}]}, {'title': '1 hr 15 min', 'categories': [{'measurements': [{'value': '0.32088', 'spread': '0.262743', 'groupId': 'OG000'}, {'value': '0.22083', 'spread': '0.143504', 'groupId': 'OG001'}]}]}, {'title': '1 hr 45 min', 'categories': [{'measurements': [{'value': '0.02309', 'spread': '0.155010', 'groupId': 'OG000'}, {'value': '-0.00873', 'spread': '0.052095', 'groupId': 'OG001'}]}]}, {'title': '2 hr', 'categories': [{'measurements': [{'value': '0.14532', 'spread': '0.152512', 'groupId': 'OG000'}, {'value': '0.08063', 'spread': '0.105769', 'groupId': 'OG001'}]}]}, {'title': '2 hr 45 min', 'categories': [{'measurements': [{'value': '0.01411', 'spread': '0.038786', 'groupId': 'OG000'}, {'value': '0.02484', 'spread': '0.030589', 'groupId': 'OG001'}]}]}, {'title': '3 hr', 'categories': [{'measurements': [{'value': '0.03145', 'spread': '0.042047', 'groupId': 'OG000'}, {'value': '0.04148', 'spread': '0.038344', 'groupId': 'OG001'}]}]}, {'title': '3 hr 30 min', 'categories': [{'measurements': [{'value': '-0.02053', 'spread': '0.047566', 'groupId': 'OG000'}, {'value': '-0.00507', 'spread': '0.033461', 'groupId': 'OG001'}]}]}, {'title': '3 hr 45 min', 'categories': [{'measurements': [{'value': '0.01197', 'spread': '0.015914', 'groupId': 'OG000'}, {'value': '0.01878', 'spread': '0.014128', 'groupId': 'OG001'}]}]}, {'title': '4 hr 15 min', 'categories': [{'measurements': [{'value': '0.00892', 'spread': '0.017889', 'groupId': 'OG000'}, {'value': '0.01401', 'spread': '0.009209', 'groupId': 'OG001'}]}]}, {'title': '4 hr 30 min', 'categories': [{'measurements': [{'value': '0.01868', 'spread': '0.011193', 'groupId': 'OG000'}, {'value': '0.02254', 'spread': '0.003796', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4', 'description': 'The insulin secretion rate (ISR) was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. ISR was measured at 1 hr, 1 hr 15 min, 1 hr 45 min, 2 hr, 2 hr 45 min, 3 hr, 3 hr 30 min, 3 hr 45 min, 4 hr 15 min, and 4 hr 30 min. Repeated-measures analysis of variance was performed on insulin secretion rate using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect.', 'unitOfMeasure': 'Milliunits per hour (mU/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population'}, {'type': 'SECONDARY', 'title': 'Epinephrine Values During the Glucose Clamp Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': '0 hr, n=19, 20', 'categories': [{'measurements': [{'value': '56.9', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '59.4', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': '1 hr, n=19, 18', 'categories': [{'measurements': [{'value': '60.7', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '61.2', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': '1 hr 15 min, n=18, 19', 'categories': [{'measurements': [{'value': '57.8', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '59.9', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': '1 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '69.1', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '70.1', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': '2 hr, n=20, 20', 'categories': [{'measurements': [{'value': '73.2', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': '2 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '183.9', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '159.2', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': '3 hr, n=19, 21', 'categories': [{'measurements': [{'value': '187.1', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '171.1', 'spread': '1.97', 'groupId': 'OG001'}]}]}, {'title': '3 hr 30 min, n=19, 21', 'categories': [{'measurements': [{'value': '429.2', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '372.3', 'spread': '1.97', 'groupId': 'OG001'}]}]}, {'title': '3 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '410.3', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '318.8', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': '4 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '568.3', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '519.5', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': '4 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '608.7', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '505.6', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': '4 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '477.1', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '395.4', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': '5 hr, n=20, 21', 'categories': [{'measurements': [{'value': '246.6', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '225.9', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': '5 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '172.4', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '154.4', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': '5 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '132.5', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '118.2', 'spread': '1.62', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4', 'description': 'Epinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.', 'unitOfMeasure': 'Nanograms per liter (ng/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.'}, {'type': 'SECONDARY', 'title': 'Norepinephrine Values During the Glucose Clamp Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': '0 hr, n=20, 21', 'categories': [{'measurements': [{'value': '340.6', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '357.0', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': '1 hr, n=20, 21', 'categories': [{'measurements': [{'value': '347.1', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '360.9', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': '1 hr 15 min, n=19, 21', 'categories': [{'measurements': [{'value': '382.3', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '376.2', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': '1 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '347.7', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '424.6', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': '2 hr, n=20, 20', 'categories': [{'measurements': [{'value': '346.3', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '382.5', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': '2 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '425.5', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '421.2', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': '3 hr, n=20, 21', 'categories': [{'measurements': [{'value': '425.0', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '411.9', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': '3 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '543.2', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '519.2', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': '3 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '537.5', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '447.5', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': '4 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '624.0', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '618.0', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': '4 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '649.5', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '622.2', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': '4 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '605.0', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '605.8', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': '5 hr , n=20, 21', 'categories': [{'measurements': [{'value': '508.4', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '485.4', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': '5 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '511.3', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '464.4', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': '5 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '469.4', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '444.7', 'spread': '1.42', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4', 'description': 'Norepinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.', 'unitOfMeasure': 'Nanograms per liter (ng/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.'}, {'type': 'SECONDARY', 'title': 'Growth Hormone Values During the Glucose Clamp Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': '0 hr, n=20, 21', 'categories': [{'measurements': [{'value': '0.29', 'spread': '3.093', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '2.875', 'groupId': 'OG001'}]}]}, {'title': '1 hr, n=20, 21', 'categories': [{'measurements': [{'value': '0.17', 'spread': '2.170', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '2.791', 'groupId': 'OG001'}]}]}, {'title': '1 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.16', 'spread': '2.294', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '2.722', 'groupId': 'OG001'}]}]}, {'title': '1 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.34', 'spread': '3.160', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '3.729', 'groupId': 'OG001'}]}]}, {'title': '2 hr, n=20, 20', 'categories': [{'measurements': [{'value': '0.60', 'spread': '3.343', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '4.696', 'groupId': 'OG001'}]}]}, {'title': '2 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '2.44', 'spread': '2.910', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '3.080', 'groupId': 'OG001'}]}]}, {'title': '3 hr, n=20, 21', 'categories': [{'measurements': [{'value': '3.16', 'spread': '2.641', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '1.971', 'groupId': 'OG001'}]}]}, {'title': '3 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '4.83', 'spread': '1.764', 'groupId': 'OG000'}, {'value': '4.81', 'spread': '1.832', 'groupId': 'OG001'}]}]}, {'title': '3 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '4.36', 'spread': '1.868', 'groupId': 'OG000'}, {'value': '4.61', 'spread': '1.819', 'groupId': 'OG001'}]}]}, {'title': '4 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '3.59', 'spread': '1.864', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '1.515', 'groupId': 'OG001'}]}]}, {'title': '4 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '3.39', 'spread': '1.722', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '1.496', 'groupId': 'OG001'}]}]}, {'title': '4 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '3.41', 'spread': '1.703', 'groupId': 'OG000'}, {'value': '3.93', 'spread': '1.606', 'groupId': 'OG001'}]}]}, {'title': '5 hr, n=20, 21', 'categories': [{'measurements': [{'value': '2.55', 'spread': '1.778', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '1.812', 'groupId': 'OG001'}]}]}, {'title': '5 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '1.77', 'spread': '2.030', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '1.945', 'groupId': 'OG001'}]}]}, {'title': '5 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '1.07', 'spread': '1.906', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '2.024', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4', 'description': 'Growth hormone levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.', 'unitOfMeasure': 'Micrograms per liter (µg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.'}, {'type': 'SECONDARY', 'title': 'Insulin Values During the Glucose Clamp Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': '0 hr, n=20, 21', 'categories': [{'measurements': [{'value': '140.5', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '102.4', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': '1 hr, n=20, 21', 'categories': [{'measurements': [{'value': '297.5', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '183.6', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': '1 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '385.9', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '270.9', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': '1 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '250.6', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '207.4', 'spread': '2.20', 'groupId': 'OG001'}]}]}, {'title': '2 hr, n=20, 20', 'categories': [{'measurements': [{'value': '437.4', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '357.3', 'spread': '1.81', 'groupId': 'OG001'}]}]}, {'title': '2 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '298.3', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '191.9', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': '3 hr, n=20, 21', 'categories': [{'measurements': [{'value': '680.2', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '438.7', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': '3 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '677.1', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '488.0', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': '3 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '1000.6', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '861.2', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': '4 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '1738.7', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '887.9', 'spread': '2.91', 'groupId': 'OG001'}]}]}, {'title': '4 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '1057.8', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '758.1', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': '4 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '203.0', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '115.5', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': '5 hr, n=20, 21', 'categories': [{'measurements': [{'value': '121.7', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '75.6', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': '5 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '99.5', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '69.6', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': '5 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '94.0', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '65.1', 'spread': '2.15', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4', 'description': 'Insulin levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.', 'unitOfMeasure': 'Picomoles per liter (pmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.'}, {'type': 'SECONDARY', 'title': 'Cortisol Values During the Glucose Clamp Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': '0 hr, n=20, 21', 'categories': [{'measurements': [{'value': '260.9', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '282.9', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': '1 hr, n=20, 21', 'categories': [{'measurements': [{'value': '208.9', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '250.5', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': '1 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '207.4', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '272.3', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': '1 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '233.2', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '230.2', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': '2 hr, n=20, 20', 'categories': [{'measurements': [{'value': '231.0', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '230.7', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': '2 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '273.9', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '290.4', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': '3 hr, n=20, 21', 'categories': [{'measurements': [{'value': '392.1', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '344.0', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': '3 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '597.0', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '534.7', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': '3 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '667.7', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '583.0', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': '4 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '746.4', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '674.0', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': '4 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '758.2', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '705.2', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': '4 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '780.0', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '712.0', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': '5 hr, n=20, 21', 'categories': [{'measurements': [{'value': '718.9', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '673.3', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': '5 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '703.4', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '626.8', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': '5 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '646.4', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '569.0', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4', 'description': 'Cortisol levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.', 'unitOfMeasure': 'Nanomoles per liter (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.'}, {'type': 'SECONDARY', 'title': 'C-peptide Values During the Glucose Clamp Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': '0 hr, n=20, 21', 'categories': [{'measurements': [{'value': '1.095', 'spread': '1.4141', 'groupId': 'OG000'}, {'value': '0.836', 'spread': '1.2694', 'groupId': 'OG001'}]}]}, {'title': '1 hr, n=20, 21', 'categories': [{'measurements': [{'value': '1.616', 'spread': '1.9504', 'groupId': 'OG000'}, {'value': '0.993', 'spread': '1.8530', 'groupId': 'OG001'}]}]}, {'title': '1 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '1.630', 'spread': '1.9941', 'groupId': 'OG000'}, {'value': '1.053', 'spread': '1.8949', 'groupId': 'OG001'}]}]}, {'title': '1 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.786', 'spread': '2.2046', 'groupId': 'OG000'}, {'value': '0.517', 'spread': '1.8094', 'groupId': 'OG001'}]}]}, {'title': '2 hr, n=20, 20', 'categories': [{'measurements': [{'value': '0.723', 'spread': '2.1648', 'groupId': 'OG000'}, {'value': '0.484', 'spread': '1.8073', 'groupId': 'OG001'}]}]}, {'title': '2 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.362', 'spread': '2.2903', 'groupId': 'OG000'}, {'value': '0.275', 'spread': '1.8736', 'groupId': 'OG001'}]}]}, {'title': '3 hr, n=20, 21', 'categories': [{'measurements': [{'value': '0.309', 'spread': '2.2762', 'groupId': 'OG000'}, {'value': '0.255', 'spread': '1.8769', 'groupId': 'OG001'}]}]}, {'title': '3 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.152', 'spread': '1.7438', 'groupId': 'OG000'}, {'value': '0.138', 'spread': '1.3718', 'groupId': 'OG001'}]}]}, {'title': '3 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.140', 'spread': '1.5595', 'groupId': 'OG000'}, {'value': '0.128', 'spread': '1.3047', 'groupId': 'OG001'}]}]}, {'title': '4 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.105', 'spread': '1.1483', 'groupId': 'OG000'}, {'value': '0.101', 'spread': '1.0589', 'groupId': 'OG001'}]}]}, {'title': '4 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.100', 'spread': '1.0000', 'groupId': 'OG000'}, {'value': '0.100', 'spread': '1.0000', 'groupId': 'OG001'}]}]}, {'title': '4 hr 45 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.100', 'spread': '1.0000', 'groupId': 'OG000'}, {'value': '0.100', 'spread': '1.0000', 'groupId': 'OG001'}]}]}, {'title': '5 hr, n=20, 21', 'categories': [{'measurements': [{'value': '0.105', 'spread': '1.1483', 'groupId': 'OG000'}, {'value': '0.103', 'spread': '1.0821', 'groupId': 'OG001'}]}]}, {'title': '5 hr 15 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.118', 'spread': '1.4512', 'groupId': 'OG000'}, {'value': '0.120', 'spread': '1.3662', 'groupId': 'OG001'}]}]}, {'title': '5 hr 30 min, n=20, 21', 'categories': [{'measurements': [{'value': '0.141', 'spread': '1.6701', 'groupId': 'OG000'}, {'value': '0.138', 'spread': '1.4534', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4', 'description': 'C-peptide levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.', 'unitOfMeasure': 'Nanomoles per liter (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.'}, {'type': 'SECONDARY', 'title': 'Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.00', 'groupId': 'OG000', 'lowerLimit': '30.00', 'upperLimit': '45.00'}, {'value': '30.00', 'groupId': 'OG001', 'lowerLimit': '25.00', 'upperLimit': '40.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 4', 'description': 'The effect of albiglutide and placebo on the recovery time of plasma glucose levels to \\>=3.9 mmol/L (7\\>=0 mg/dL) from the hypoglycemic clamp level of 2.8 nmol/L (50.4 mg/dL) was calculated as the time in minutes between switching off of the insulin infusion and reaching the level of \\>=3.9 mmol/L (\\>=70 mg/dL). Censored values were censored at 70 minutes. The median and 95% confidence interval data are obtained from Kaplan-Meier estimates.', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population'}, {'type': 'SECONDARY', 'title': 'Average Albiglutide Concentration on the Day of the Clamp Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': 'Week 1, Day 4, 0 hours', 'categories': [{'measurements': [{'value': '2110.5', 'spread': '905.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 1, Day 4, 4 hours 45 minutes', 'categories': [{'measurements': [{'value': '1968.7', 'spread': '754.37', 'groupId': 'OG000'}]}]}, {'title': 'Average Concentration', 'categories': [{'measurements': [{'value': '2039.63', 'spread': '826.584', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4', 'description': 'Plasma samples were taken from participants at two time points on Day 4 (at 0 hours and 4 hours and 45 minutes post-dose) of Week 1 of the study for albiglutide study drug level analyses. The average concentration for each participant was calculated as the mean of the concentrations at 0 hours and 4 hours 45 minutes. The clamp procedure is a glucose-controlled insulin infusion system. Variable infusions of glucose are administered to achieve various glucose target levels. It is a way of quantifying insulin secretion and resistance.', 'unitOfMeasure': 'Nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Albiglutide Pharmacokinetic Population: all participants who had at least one sample to compute albiglutide exposure'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'classes': [{'title': 'Any treatment-emergent non-serious AE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any treatment-emergent SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks)', 'description': 'Treatment-emergent AEs are defined as those with an onset on or after study drug administration. 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 AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received one dose of albiglutide or placebo. The Safety Population was analyzed according to treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Eligible participants entered a 1-week Screening Period, a 2-week Run-in/Stabilization Period, a 4-day Treatment Period for the evaluation of efficacy and safety, and an 8-week post-treatment Follow-up Period. A total of 45 participants were screened, 44 were randomized, and 41 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received a single dose of albiglutide (50 milligrams \\[mg\\]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter \\[mg/dL\\], respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.9', 'spread': '6.86', 'groupId': 'BG000'}, {'value': '48.4', 'spread': '9.32', 'groupId': 'BG001'}, {'value': '49.1', 'spread': '8.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mexican', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Persian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2012-11-21', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-20', 'studyFirstSubmitDate': '2011-11-17', 'dispFirstSubmitQcDate': '2012-11-21', 'resultsFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2011-11-17', 'dispFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-17', 'studyFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure', 'timeFrame': 'Day 4', 'description': 'Plasma glucagon levels were measured for the estimation of glucagon secretion during the hypoglycemic periods. Glucagon response was measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on non-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification (0.03780 nmol/L) were set to the quantification limit for summary.'}], 'secondaryOutcomes': [{'measure': 'Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period', 'timeFrame': 'Day 4', 'description': 'The insulin secretion rate (ISR) was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. ISR was measured at 1 hr, 1 hr 15 min, 1 hr 45 min, 2 hr, 2 hr 45 min, 3 hr, 3 hr 30 min, 3 hr 45 min, 4 hr 15 min, and 4 hr 30 min. Repeated-measures analysis of variance was performed on insulin secretion rate using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect.'}, {'measure': 'Epinephrine Values During the Glucose Clamp Period', 'timeFrame': 'Day 4', 'description': 'Epinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.'}, {'measure': 'Norepinephrine Values During the Glucose Clamp Period', 'timeFrame': 'Day 4', 'description': 'Norepinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.'}, {'measure': 'Growth Hormone Values During the Glucose Clamp Period', 'timeFrame': 'Day 4', 'description': 'Growth hormone levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.'}, {'measure': 'Insulin Values During the Glucose Clamp Period', 'timeFrame': 'Day 4', 'description': 'Insulin levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.'}, {'measure': 'Cortisol Values During the Glucose Clamp Period', 'timeFrame': 'Day 4', 'description': 'Cortisol levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.'}, {'measure': 'C-peptide Values During the Glucose Clamp Period', 'timeFrame': 'Day 4', 'description': 'C-peptide levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \\[hr\\], 1hr, 1 hr 15 minutes \\[min\\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.'}, {'measure': 'Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)', 'timeFrame': 'Day 4', 'description': 'The effect of albiglutide and placebo on the recovery time of plasma glucose levels to \\>=3.9 mmol/L (7\\>=0 mg/dL) from the hypoglycemic clamp level of 2.8 nmol/L (50.4 mg/dL) was calculated as the time in minutes between switching off of the insulin infusion and reaching the level of \\>=3.9 mmol/L (\\>=70 mg/dL). Censored values were censored at 70 minutes. The median and 95% confidence interval data are obtained from Kaplan-Meier estimates.'}, {'measure': 'Average Albiglutide Concentration on the Day of the Clamp Procedure', 'timeFrame': 'Day 4', 'description': 'Plasma samples were taken from participants at two time points on Day 4 (at 0 hours and 4 hours and 45 minutes post-dose) of Week 1 of the study for albiglutide study drug level analyses. The average concentration for each participant was calculated as the mean of the concentrations at 0 hours and 4 hours 45 minutes. The clamp procedure is a glucose-controlled insulin infusion system. Variable infusions of glucose are administered to achieve various glucose target levels. It is a way of quantifying insulin secretion and resistance.'}, {'measure': 'Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period', 'timeFrame': 'From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks)', 'description': 'Treatment-emergent AEs are defined as those with an onset on or after study drug administration. 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 AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['glucose clamp', 'hypoglycemia'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': '108372', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108372', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108372', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108372', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108372', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108372', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108372', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], '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.'}, {'pmid': '25263215', 'type': 'DERIVED', 'citation': 'Hompesch M, Jones-Leone A, Carr MC, Matthews J, Zhi H, Young M, Morrow L, Reinhardt RR. Albiglutide does not impair the counter-regulatory hormone response to hypoglycaemia: a randomized, double-blind, placebo-controlled, stepped glucose clamp study in subjects with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jan;17(1):82-90. doi: 10.1111/dom.12398. Epub 2014 Oct 26.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner.', 'detailedDescription': 'This is a Phase II, single-site, randomized, double-blind, parallel-group, placebo-controlled, stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given 3 days before employing a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner. In particular, this study is being conducted to ensure that albiglutide does not impair counter-regulatory responses during hypoglycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before Screening\n* HbA1c \\<10% at Screening for subjects who do not require washout of existing OAD or \\<9% at Screening for subjects who do require washout from existing OAD\n* Body mass index in range 28 kg/m2 to40 kg/m2\n\nExclusion Criteria:\n\n* History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis\n* History of significant gastrointestinal surgery,\n* History of significant cardiovascular disease\n* History of a seizure disorder\n* Documented hypertension or hypotension\n* Use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.\n* Current hepatic disease or abnormal liver function tests\n* Positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus infection 1 or 2\n* History of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)\n* Female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum\n* Known allergy to any GLP-1 analog or excipients of albiglutide, Baker's yeast, or insulin\n* History of type 1 diabetes,\n* Prior exposure to GLP-1 agents, including albiglutide\n* Blood donation over 500 mL within 8 weeks before Screening"}, 'identificationModule': {'nctId': 'NCT01475734', 'briefTitle': 'Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Single-site, Randomized, Double-blind, Placebo-controlled, Parallel-group, Stepped Glucose Clamp Study to Assess the Effects of Albiglutide on Counter-regulatory Hormone Responses and Recovery From Hypoglycemia in Subjects With Type 2 Diabetes Mellitus.', 'orgStudyIdInfo': {'id': '108372'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'albiglutide', 'description': 'single dose of albiglutide', 'interventionNames': ['Biological: albiglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'single dose of placebo', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'albiglutide', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection', 'armGroupLabels': ['albiglutide']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}