Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT01098461
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2010-02-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Ranging Study of Albiglutide in Japanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534611', 'term': 'rGLP-1 protein'}]}}, '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': 'On-therapy serious adverse events (SAEs)/non-serious AEs, with a start date on/after the first day of study medication (SM) and within 56 days after the end of SM, were collected from the start of SM until Follow-up/Early Withdrawal (up to Study Day 168).', 'description': 'On-therapy SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': "Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.", 'otherNumAtRisk': 53, 'otherNumAffected': 21, 'seriousNumAtRisk': 53, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Albiglutide 15 mg Weekly', 'description': "Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.", 'otherNumAtRisk': 52, 'otherNumAffected': 27, 'seriousNumAtRisk': 52, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Albiglutide 30 mg Weekly', 'description': "Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.", 'otherNumAtRisk': 54, 'otherNumAffected': 20, 'seriousNumAtRisk': 54, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Albiglutide 30 mg Every Other Week', 'description': "Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.", 'otherNumAtRisk': 53, 'otherNumAffected': 23, 'seriousNumAtRisk': 53, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG001', 'title': 'Albiglutide 15 mg Weekly', 'description': "Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG002', 'title': 'Albiglutide 30 mg Weekly', 'description': "Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Every Other Week', 'description': "Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '-1.27', 'spread': '0.095', 'groupId': 'OG002'}, {'value': '-0.82', 'spread': '0.096', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.89', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '-0.57', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons."}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.55', 'ciLowerLimit': '-1.88', 'ciUpperLimit': '-1.23', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons."}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '-0.78', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons."}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.', 'unitOfMeasure': 'Percentage of HbA1c in the blood', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants with at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG001', 'title': 'Albiglutide 15 mg Weekly', 'description': "Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG002', 'title': 'Albiglutide 30 mg Weekly', 'description': "Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Every Other Week', 'description': "Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.349', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.301', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.377', 'groupId': 'OG002'}, {'value': '-0.36', 'spread': '0.383', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.628', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.430', 'groupId': 'OG001'}, {'value': '-1.07', 'spread': '0.578', 'groupId': 'OG002'}, {'value': '-0.74', 'spread': '0.618', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.730', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.464', 'groupId': 'OG001'}, {'value': '-1.26', 'spread': '0.649', 'groupId': 'OG002'}, {'value': '-0.84', 'spread': '0.720', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.743', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.548', 'groupId': 'OG001'}, {'value': '-1.29', 'spread': '0.736', 'groupId': 'OG002'}, {'value': '-0.84', 'spread': '0.875', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4, Week 8, Week 12, and Week 16', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.', 'unitOfMeasure': 'Percentage of HbA1c in the blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG001', 'title': 'Albiglutide 15 mg Weekly', 'description': "Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG002', 'title': 'Albiglutide 30 mg Weekly', 'description': "Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Every Other Week', 'description': "Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.30', 'spread': '1.190', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '1.378', 'groupId': 'OG001'}, {'value': '-2.27', 'spread': '1.465', 'groupId': 'OG002'}, {'value': '-1.32', 'spread': '1.271', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.41', 'spread': '1.451', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '1.585', 'groupId': 'OG001'}, {'value': '-2.27', 'spread': '1.652', 'groupId': 'OG002'}, {'value': '-1.19', 'spread': '1.458', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.612', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '1.511', 'groupId': 'OG001'}, {'value': '-1.92', 'spread': '1.388', 'groupId': 'OG002'}, {'value': '-1.06', 'spread': '1.555', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.50', 'spread': '2.448', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '1.583', 'groupId': 'OG001'}, {'value': '-1.92', 'spread': '1.667', 'groupId': 'OG002'}, {'value': '-0.78', 'spread': '1.821', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4, Week 8, Week 12, and Week 16', 'description': 'The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'unitOfMeasure': 'Millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 4, 8, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG001', 'title': 'Albiglutide 15 mg Weekly', 'description': "Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG002', 'title': 'Albiglutide 30 mg Weekly', 'description': "Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Every Other Week', 'description': "Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.956', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.752', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '1.268', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '1.120', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '1.289', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.926', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '1.671', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '1.684', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '1.409', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '1.277', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '1.906', 'groupId': 'OG002'}, {'value': '-0.22', 'spread': '1.459', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '1.715', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '1.468', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '1.977', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '1.740', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4, Week 8, Week 12, and Week 16', 'description': 'The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG001', 'title': 'Albiglutide 15 mg Weekly', 'description': "Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG002', 'title': 'Albiglutide 30 mg Weekly', 'description': "Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Every Other Week', 'description': "Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'title': 'HbA1c <6.5%, Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <6.5%, Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <6.5%, Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <6.5%, Week 16', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <7%, Week 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <7%, Week 8', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <7%, Week 12', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <7%, Week 16', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, Week 8, Week 12, and Week 16', 'description': 'The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5% and \\<7%) were assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.'}, {'type': 'SECONDARY', 'title': 'Mean Clearance of Albiglutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 15/30 mg Weekly or 30 mg Every Other Week', 'description': "Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '45.7', 'upperLimit': '49.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24', 'description': 'Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.', 'unitOfMeasure': 'milliliters per hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Population: all participants for whom a PK sample was obtained and analyzed'}, {'type': 'SECONDARY', 'title': 'Mean Volume of Distribution of Albiglutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 15/30 mg Weekly or 30 mg Every Other Week', 'description': "Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '9.34', 'groupId': 'OG000', 'lowerLimit': '8.71', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24', 'description': 'Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Population'}, {'type': 'SECONDARY', 'title': 'Mean Absorption Rate of Albiglutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 15/30 mg Weekly or 30 mg Every Other Week', 'description': "Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0154', 'groupId': 'OG000', 'lowerLimit': '0.0134', 'upperLimit': '0.0183'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24', 'description': 'Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.', 'unitOfMeasure': 'hour^-1', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Population (Pop)'}, {'type': 'SECONDARY', 'title': 'Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 15/30 mg Weekly or 30 mg Every Other Week', 'description': "Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'classes': [{'title': 'HbA1c', 'categories': [{'measurements': [{'value': '3360', 'groupId': 'OG000', 'lowerLimit': '2440', 'upperLimit': '5260'}]}]}, {'title': 'FPG', 'categories': [{'measurements': [{'value': '3850', 'groupId': 'OG000', 'lowerLimit': '1420', 'upperLimit': '6330'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24', 'description': 'EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK/PD Analysis Pop: all participants in the PK Analysis Pop with sufficient dosing history for inclusion in the PK/PD analysis. Modeled population PK data (analyzed using a non-linear mixed effect modeling approach) are presented. A one-compartment PK model with first-order absorption/elimination processes was selected to describe GSK716155 PK.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': "Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'FG001', 'title': 'Albiglutide 15 mg Weekly', 'description': "Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'FG002', 'title': 'Albiglutide 30 mg Weekly', 'description': "Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'FG003', 'title': 'Albiglutide 30 mg Every Other Week', 'description': "Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}], 'periods': [{'title': 'Treatment Period (TP) (16 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Persistent Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Transferred to Oita (Japan)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Follow-up (FU) Period (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Par. withdrawing from the TP could enter the FU Period. One par. did not participate in the FU.', 'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'comment': 'Par. withdrawing from the TP could enter the FU Period. One par. did not participate in the FU.', 'groupId': 'FG002', 'numSubjects': '53'}, {'comment': 'Par. withdrawing from the TP could enter the FU Period. One par. did not participate in the FU.', 'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Transferred to Oita (Japan)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Follow-up Not Conducted Due to Earthquak', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants (par.) who met eligibility criteria and completed a 4- to 8-week Run-in Period were then randomized to a 16-week Treatment Period, followed by an 8-week Follow-up Period. A total of 215 participants were randomized, and 212 received \\>=1 treatment dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': "Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'BG001', 'title': 'Albiglutide 15 mg Weekly', 'description': "Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'BG002', 'title': 'Albiglutide 30 mg Weekly', 'description': "Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'BG003', 'title': 'Albiglutide 30 mg Every Other Week', 'description': "Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '11.06', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '10.29', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '9.30', 'groupId': 'BG002'}, {'value': '59.1', 'spread': '8.49', 'groupId': 'BG003'}, {'value': '57.0', 'spread': '10.00', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2012-02-16', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2010-02-12', 'dispFirstSubmitQcDate': '2012-02-16', 'resultsFirstSubmitDate': '2014-04-24', 'studyFirstSubmitQcDate': '2010-04-01', 'dispFirstPostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-29', 'studyFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16', 'timeFrame': 'Baseline; Week 4, Week 8, Week 12, and Week 16', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16', 'timeFrame': 'Baseline; Week 4, Week 8, Week 12, and Week 16', 'description': 'The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.'}, {'measure': 'Change From Baseline in Body Weight at Week 4, 8, 12, and 16', 'timeFrame': 'Baseline; Week 4, Week 8, Week 12, and Week 16', 'description': 'The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.'}, {'measure': 'Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16', 'timeFrame': 'Week 4, Week 8, Week 12, and Week 16', 'description': 'The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5% and \\<7%) were assessed.'}, {'measure': 'Mean Clearance of Albiglutide', 'timeFrame': 'Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24', 'description': 'Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.'}, {'measure': 'Mean Volume of Distribution of Albiglutide', 'timeFrame': 'Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24', 'description': 'Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.'}, {'measure': 'Mean Absorption Rate of Albiglutide', 'timeFrame': 'Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24', 'description': 'Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.'}, {'measure': 'Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG', 'timeFrame': 'Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24', 'description': 'EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dose-ranging', 'pharmacokinetics', 'GSK716155', 'Japan', 'albiglutide'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': '110932', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110932', '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': '110932', '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': '110932', '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': '110932', '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': '110932', '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': '110932', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', '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': '24552155', 'type': 'DERIVED', 'citation': 'Seino Y, Inagaki N, Miyahara H, Okuda I, Bush M, Ye J, Holland MC, Johnson S, Lewis E, Nakajima H. A randomized dose-finding study demonstrating the efficacy and tolerability of albiglutide in Japanese patients with type 2 diabetes mellitus. Curr Med Res Opin. 2014 Jun;30(6):1095-106. doi: 10.1185/03007995.2014.896327. Epub 2014 Mar 11.'}], '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 randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.', 'detailedDescription': 'This is a Phase IIb, randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging, superiority study evaluating the dose response, efficacy and safety of weekly and every other week subcutaneously injected GSK716155 (albiglutide) in subjects with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD\n* BMI ≥18 kg/m2 and \\<35 kg/m2 at Screening\n* HbA1c between 7.0% and 10.0%, inclusive\n* Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)\n* Female subjects of childbearing potential must be practicing adequate contraception .\n* Able and willing to monitor his/her own blood glucose concentrations with a home glucose monitor.\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus\n* Uncorrected thyroid dysfunction\n* Previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening\n* Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:\n\n * Previous history of stroke or transient ischemic attack\n * Active, unstable coronary heart disease within the past six months before Screening\n * Documented myocardial infarction within one year before Screening\n * Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within one year before Screening\n * Unstable angina\n * Clinically significant arrhythmia or valvular heart disease\n * Current heart failure NYHA class II to IV\n * Resting systolic pressure \\>160 mm Hg or diastolic pressure \\>95 mm Hg at Screening\n * ECG criteria at Screening\n* Heart rate: \\<40 and \\>110 bpm\n* PR interval: \\<120 and \\> 210 msec\n* QRS interval: \\<70 and \\>120 msec\n* QTc interval (Bazett): \\>450 msec or \\>480 msec with bundle branch block\n* Fasting triglyceride level \\>400 mg/dL at Screening\n* AST or ALT \\>2xULN, ALP and bilirubin \\>1.5xULN (except known Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin \\<35% of total bilirubin)\n* If female, is currently lactating, within 6 weeks post-partum, pregnant, or actively trying to become pregnant\n* Has significant renal disease as manifested by one or more of the following:\n\n * Creatinine clearance at screening \\<60 mL/min (calculated by Cockcroft-Gault formula) at Screening\n * Known loss of a kidney either by surgical ablation, injury or disease level\n* A hemoglobinopathy that may affect determination of HbA1c level\n* History of treated diabetic gastroparesis\n* History of significant gastrointestinal surgery, including gastric bypass and banding, or surgeries thought to significantly affect upper gastrointestinal function\n* Current ongoing symptomatic biliary disease or history of acute/chronic pancreatitis.\n* Lipase and amylase at Screening \\> ULN\n* Severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma\n* History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)\n* Acute or chronic history of liver disease, positive hepatitis B surface antigen (HBsAg) or positive hepatitis C testing at Screening\n* Current and history of alcohol or substance abuse\n* Clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant\n* Prior use of a GLP-1 analog\n* Known allergy to any formulation excipients, or Baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation\n* History of or family history of medullary carcinoma of the thyroid.\n* History of or family history of multiple endocrine neoplasia type 2\n* Receipt of any investigational drug within the 12 weeks before Screening"}, 'identificationModule': {'nctId': 'NCT01098461', 'briefTitle': 'Dose Ranging Study of Albiglutide in Japanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Dose Finding Study of GSK716155 Versus Placebo in the Treatment of Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '110932'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'albiglutide 15mg weekly', 'description': 'once weekly subcutaneous injection of albiglutide 15mg', 'interventionNames': ['Biological: albiglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'albiglutide 30mg weekly', 'description': 'once weekly subcutaneous injection of albiglutide 30mg', 'interventionNames': ['Biological: albiglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'albiglutide 30mg every other week', 'description': 'subcutaneous injection of 30mg albiglutide every other week', 'interventionNames': ['Biological: albiglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'once weekly subcutaneous injection of placebo to match albiglutide', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'albiglutide', 'type': 'BIOLOGICAL', 'otherNames': ['placebo', 'albiglutide 30mg weekly', 'albiglutide 15mg weekly', 'albiglutide 30mg every other week'], 'description': 'subcutaneous injection of albiglutide', 'armGroupLabels': ['albiglutide 15mg weekly', 'albiglutide 30mg every other week', 'albiglutide 30mg weekly']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection of placebo to match albiglutide', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-0815', 'city': 'Aichi', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '790-0067', 'city': 'Ehime', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '810-0001', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '811-1346', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '815-8555', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '819-0168', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '731-0103', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '003-0023', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '044-0053', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '061-1395', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '080-0010', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '080-0016', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '310-0826', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '311-0113', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '891-0401', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '210-0852', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '235-0045', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '862-0976', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '866-0862', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '980-0021', 'city': 'Miyagi', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'zip': '985-0852', 'city': 'Miyagi', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'zip': '856-0831', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '355-0321', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '362-0021', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '329-0101', 'city': 'Tochigi', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': '329-0433', 'city': 'Tochigi', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': '125-0054', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '154-0015', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '177-0041', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '990-0885', 'city': 'Yamagata', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], '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'}}}}