Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT01128894
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
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'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, '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-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring while participants were on treatment up until 56 days after the last dose (up to Week 40), are reported.', 'description': 'SAEs and AEs were collected in members of the Safety Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.', 'otherNumAtRisk': 404, 'otherNumAffected': 266, 'seriousNumAtRisk': 404, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.', 'otherNumAtRisk': 408, 'otherNumAffected': 289, 'seriousNumAtRisk': 408, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 119}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 83}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Encephalitis herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.99', 'spread': '0.046', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0846', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.34', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The p-value was from a 1-sided t test testing whether or not the difference of least square means (albiglutide - liraglutide) was less than or equal to the prespecified noninferiority margin of 0.3%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 32', '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 in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing 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 participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}], 'classes': [{'title': 'Week 4, n=387, 392', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.481', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.447', 'groupId': 'OG001'}]}]}, {'title': 'Week 6, n=398, 401', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.566', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '0.569', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=398, 402', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.824', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.798', 'groupId': 'OG001'}]}]}, {'title': 'Week 18, n=398, 402', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.921', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '0.904', 'groupId': 'OG001'}]}]}, {'title': 'Week 26, n=398, 402', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.968', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.969', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 6, 12, 18 and 26', '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 post-Baseline value minus the Baseline value. The 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. Participants were considered in the treatment week if they had received at least one dose in that treatment week.', 'unitOfMeasure': 'Percentage of HbA1c in the blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.22', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '0.115', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 32', '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. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\\<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The 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. Participants were considered in the treatment week if they had received at least one dose in that treatment week.', 'unitOfMeasure': 'Millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the indicated time point were assessed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}], 'classes': [{'title': 'Week 1, n=386, 381', 'categories': [{'measurements': [{'value': '-0.98', 'spread': '1.939', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '2.116', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n= 399, 398', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '2.194', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '2.296', 'groupId': 'OG001'}]}]}, {'title': 'Week 3, n= 400, 402', 'categories': [{'measurements': [{'value': '-1.61', 'spread': '2.067', 'groupId': 'OG000'}, {'value': '-2.43', 'spread': '2.470', 'groupId': 'OG001'}]}]}, {'title': 'Week 4, n= 400, 402', 'categories': [{'measurements': [{'value': '-1.52', 'spread': '2.148', 'groupId': 'OG000'}, {'value': '-2.45', 'spread': '2.381', 'groupId': 'OG001'}]}]}, {'title': 'Week 6, n= 400, 402', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '2.317', 'groupId': 'OG000'}, {'value': '-2.11', 'spread': '2.451', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n= 400, 402', 'categories': [{'measurements': [{'value': '-1.73', 'spread': '2.526', 'groupId': 'OG000'}, {'value': '-2.10', 'spread': '2.590', 'groupId': 'OG001'}]}]}, {'title': 'Week 18, n= 400, 402', 'categories': [{'measurements': [{'value': '-1.44', 'spread': '2.362', 'groupId': 'OG000'}, {'value': '-1.74', 'spread': '2.704', 'groupId': 'OG001'}]}]}, {'title': 'Week 26, n= 400, 402', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '2.694', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '2.717', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26', '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. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The 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. Participants were considered in the treatment week if they had received at least one dose in that treatment week.', 'unitOfMeasure': 'Millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}], 'classes': [{'title': 'HbA1c <6.5%', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.0%', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 32', 'description': 'Number of participants who achieved HbA1c response levels of \\<6.5% and \\<7.0% at Week 32 were assessed. 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the indicated time point were assessed.'}, {'type': 'SECONDARY', 'title': 'Time to Hyperglycemia Rescue at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were too few events of hyperglycemia rescue (\\<50% of participants with events) to calculate the median and confidence interval.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'There were too few events of hyperglycemia rescue (\\<50% of participants with events) to calculate the median and confidence interval.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 32', 'description': 'Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) \\>=280 milligram/decilitre (mg/dL) \\>= Week 2 and \\< Week 4, FPG \\>=250 mg/dL \\>= Week 4 and \\<Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- \\>= Week 12 and \\<Week 26, or HbA1c ≥8.5% \\>= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Body Weight at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '3.118', 'groupId': 'OG000'}, {'value': '-2.21', 'spread': '4.147', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 32', 'description': 'The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\\<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The 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. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the indicated time point were assessed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'FG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '408'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '346'}, {'groupId': 'FG001', 'numSubjects': '340'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '68'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Conflicting HbA1c Results at Screening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Eligible participants entered into 2 weeks of Prescreening and Screening; 4 weeks of Run-in/stabilization; a 32-week Treatment Period for evaluation of efficacy and safety and 8 weeks of post treatment Follow-up. A total of 1764 participants were screened, 841 were randomized and 812 received at least one dose of study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'BG000'}, {'value': '408', 'groupId': 'BG001'}, {'value': '812', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Albiglutide 50 mg', 'description': 'Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.'}, {'id': 'BG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '10.11', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '9.95', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '10.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '561', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 841}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2012-07-26', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-09', 'studyFirstSubmitDate': '2010-04-29', 'dispFirstSubmitQcDate': '2012-07-26', 'resultsFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2010-05-21', 'dispFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-17', 'studyFirstPostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32', 'timeFrame': 'Baseline and Week 32', '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 in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing 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': 'Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26', 'timeFrame': 'Baseline, Weeks 4, 6, 12, 18 and 26', '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 post-Baseline value minus the Baseline value. The 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. Participants were considered in the treatment week if they had received at least one dose in that treatment week.'}, {'measure': 'Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32', 'timeFrame': 'Baseline and Week 32', '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. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\\<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The 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. Participants were considered in the treatment week if they had received at least one dose in that treatment week.'}, {'measure': 'Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26', '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. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The 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. Participants were considered in the treatment week if they had received at least one dose in that treatment week.'}, {'measure': 'Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32', 'timeFrame': 'Week 32', 'description': 'Number of participants who achieved HbA1c response levels of \\<6.5% and \\<7.0% at Week 32 were assessed. 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': 'Time to Hyperglycemia Rescue at Week 32', 'timeFrame': 'Week 32', 'description': 'Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) \\>=280 milligram/decilitre (mg/dL) \\>= Week 2 and \\< Week 4, FPG \\>=250 mg/dL \\>= Week 4 and \\<Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- \\>= Week 12 and \\<Week 26, or HbA1c ≥8.5% \\>= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.'}, {'measure': 'Mean Change From Baseline in Body Weight at Week 32', 'timeFrame': 'Baseline and Week 32', 'description': 'The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\\<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The 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. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GSK716155', 'liraglutide', 'albiglutide', 'open-label'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': '114179', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114179', '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': '114179', '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': '114179', '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': '114179', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114179', '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': '114179', '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'}], 'references': [{'pmid': '24703047', 'type': 'DERIVED', 'citation': 'Pratley RE, Nauck MA, Barnett AH, Feinglos MN, Ovalle F, Harman-Boehm I, Ye J, Scott R, Johnson S, Stewart M, Rosenstock J; HARMONY 7 study group. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014 Apr;2(4):289-297. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6.'}], '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 open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.', 'detailedDescription': 'This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications\n* BMI \\>/=20kg/m2 and \\</=45 kg/m2\n* Fasting C-peptide \\>/=0.8 ng/mL (\\>/=0.26 nmol/L)\n* HbA1c between 7.0% and 10.0%, inclusive\n* Female subjects of childbearing potential must be practicing adequate contraception.\n\nExclusion Criteria:\n\n* History of cancer\n* History of treated diabetic gastroparesis\n* Current biliary disease or history of pancreatitis\n* History of significant GI surgery\n* Recent clinically significant cardiovascular and/or cerebrovascular disease\n* Hypertension\n* History of human immunodeficiency virus infection\n* History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C\n* History of alcohol or substance abuse\n* Female subject is pregnant, lactating, or \\<6 weeks postpartum\n* Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast\n* History of type 1 diabetes mellitus\n* Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)\n* Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies\n* History or family history of thyroid disease"}, 'identificationModule': {'nctId': 'NCT01128894', 'briefTitle': 'A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '114179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'albiglutide', 'description': 'weekly albiglutide subcutaneous injection', 'interventionNames': ['Biological: albiglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'liraglutide', 'description': 'liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'albiglutide', 'type': 'BIOLOGICAL', 'description': 'albiglutide weekly subcutaneous injection', 'armGroupLabels': ['albiglutide']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': 'liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.', 'armGroupLabels': ['liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85295', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72143', 'city': 'Searcy', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.25064, 'lon': -91.73625}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': 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Investigational Site', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32927', 'city': 'Cocoa', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.38612, 'lon': -80.742}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32822', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, 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