Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT00838903
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2009-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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 AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.', 'description': 'SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.', 'otherNumAtRisk': 101, 'otherNumAffected': 75, 'seriousNumAtRisk': 101, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.', 'otherNumAtRisk': 302, 'otherNumAffected': 229, 'seriousNumAtRisk': 302, 'seriousNumAffected': 32}, {'id': 'EG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.', 'otherNumAtRisk': 307, 'otherNumAffected': 258, 'seriousNumAtRisk': 307, 'seriousNumAffected': 36}, {'id': 'EG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.', 'otherNumAtRisk': 302, 'otherNumAffected': 242, 'seriousNumAtRisk': 302, 'seriousNumAffected': 44}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 102}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 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'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viith nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervical Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '293', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.065', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '0.064', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': '0.065', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '-0.65', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '-0.17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.09', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'The p-value is for superiority testing of albiglutide over placebo at 0.05 level.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - placebo) is equal to zero', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.'}, {'pValue': '0.0001', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - sitagliptin) is equal to zero.', 'testedNonInferiority': False}, {'pValue': '0.0033', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 104', '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 BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.', 'unitOfMeasure': 'Percentage of HbA1c in the blood', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received \\>=1 dose of study medication and who had a BL assessment and \\>=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 104.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.820', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '1.160', 'groupId': 'OG001'}, {'value': '-0.59', 'spread': '0.999', 'groupId': 'OG002'}, {'value': '-0.88', 'spread': '0.959', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 156', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed .', 'unitOfMeasure': 'Percentage of HbA1c in the blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}, {'value': '296', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.277', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.160', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '0.159', 'groupId': 'OG002'}, {'value': '-0.98', 'spread': '0.161', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 104', 'description': 'The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.', 'unitOfMeasure': 'Millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG at Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '1.498', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '2.519', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': '2.684', 'groupId': 'OG002'}, {'value': '-1.30', 'spread': '2.602', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 156', '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 Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.', 'unitOfMeasure': 'Millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '293', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'title': 'HbA1c <6.5%', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <7.0%', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <7.5%', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': 'The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 52) were assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'title': 'HbA1c <6.5%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <7.0%', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c <7.5%', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 156', 'description': 'The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 156) were assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Hyperglycemia Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}, {'value': '297', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.71', 'groupId': 'OG000', 'lowerLimit': '53.14', 'upperLimit': '122.14'}, {'value': 'NA', 'comment': 'There were few events of hyperglycemia rescue (\\<50% of participants with events) to calculate the median and confidence interval.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'There were few events of hyperglycemia rescue (\\<50% of participants with events) to calculate the median and confidence interval.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'There were few events of hyperglycemia rescue (\\<50% of participants with events) to calculate the median and confidence interval.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study medication until the end of the treatment (up to Week 156)', 'description': 'Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG \\>=280 milligrams/deciliter (mg/dL) between \\>=Week 2 and \\<Week 4; FPG \\>=250 mg/dL between \\>=Week 4 and \\<Week 12; HbA1c \\>=8.5% and a \\<=0.5% reduction from Baseline between \\>=Week 12 and \\<Week 24; HbA1c \\>=8.5% between \\>=Week 24 and \\<Week 48; HbA1c \\>=8.0% between \\>= Week 48 and \\<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}, {'value': '296', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'spread': '0.411', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.237', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '0.237', 'groupId': 'OG002'}, {'value': '-1.21', 'spread': '0.239', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 104', 'description': 'The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'OG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.61', 'spread': '3.460', 'groupId': 'OG000'}, {'value': '-2.05', 'spread': '4.109', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '4.760', 'groupId': 'OG002'}, {'value': '-2.31', 'spread': '5.093', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 156', 'description': 'The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'FG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'FG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'FG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}], 'periods': [{'title': 'Treatment Period (156 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '302'}, {'groupId': 'FG002', 'numSubjects': '307'}, {'groupId': 'FG003', 'numSubjects': '302'}]}, {'type': 'Missing Active Treatment Status', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '190'}, {'groupId': 'FG002', 'numSubjects': '191'}, {'groupId': 'FG003', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '110'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Severe or Repeated Hypoglycaemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Termination of Study/Site by GSK', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Patient and PI Decision to Discontinue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Poor Glycemic Control', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Poor Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'PI Decided for Safety Purpose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Site Closed and Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject Migrated to Other Country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Missing Active Treatment Status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Period (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants withdrawing from the Treatment Period entered the Follow-up Period.', 'groupId': 'FG000', 'numSubjects': '101'}, {'comment': 'Participants withdrawing from the Treatment Period entered the Follow-up Period.', 'groupId': 'FG001', 'numSubjects': '302'}, {'comment': 'Participants withdrawing from the Treatment Period entered the Follow-up Period.', 'groupId': 'FG002', 'numSubjects': '307'}, {'comment': 'Participants withdrawing from the Treatment Period entered the Follow-up Period.', 'groupId': 'FG003', 'numSubjects': '302'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '237'}, {'groupId': 'FG002', 'numSubjects': '243'}, {'groupId': 'FG003', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'Did Not Enter Follow-up Period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Subject Withdrawn from Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Termination of Study/Site by GSK', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'ICF Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Investigator Stopped Study at Site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject Moved out of Town', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Eligible participants (par.) entered a 2-week Screening Period, a 4-week Run-in/Stabilization Period, a 156-week Treatment Period, and a 8-week post-treatment Follow-up Period. A total of 1525 par. were screened, 1049 were randomized and 1012 par. received at least 1 dose of study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}, {'value': '1012', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Plus Metformin', 'description': 'Participants received metformin \\>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'BG001', 'title': 'Sitagliptin 100 mg Plus Metformin', 'description': 'Participants received sitagliptin 100 mg daily plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'BG002', 'title': 'Glimepiride 2 mg Plus Metformin', 'description': 'Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \\>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'BG003', 'title': 'Albiglutide 30 mg Plus Metformin', 'description': 'Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '10.01', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '9.81', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '9.97', 'groupId': 'BG002'}, {'value': '54.3', 'spread': '10.12', 'groupId': 'BG003'}, {'value': '54.5', 'spread': '9.97', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}, {'value': '530', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '482', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '150', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}, {'value': '723', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'A participant may have been counted in more than one category.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1049}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-18', 'studyFirstSubmitDate': '2009-02-05', 'resultsFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2009-02-05', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-17', 'studyFirstPostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104', 'timeFrame': 'Baseline and Week 104', '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 BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 156', 'timeFrame': 'Baseline and Week 156', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed .'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104', 'timeFrame': 'Baseline and Week 104', 'description': 'The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.'}, {'measure': 'Change From Baseline in FPG at Week 156', 'timeFrame': 'Baseline and Week 156', '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 Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.'}, {'measure': 'Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104', 'timeFrame': 'Week 104', 'description': 'The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 52) were assessed.'}, {'measure': 'Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156', 'timeFrame': 'Week 156', 'description': 'The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 156) were assessed.'}, {'measure': 'Time to Hyperglycemia Rescue', 'timeFrame': 'From the start of study medication until the end of the treatment (up to Week 156)', 'description': 'Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG \\>=280 milligrams/deciliter (mg/dL) between \\>=Week 2 and \\<Week 4; FPG \\>=250 mg/dL between \\>=Week 4 and \\<Week 12; HbA1c \\>=8.5% and a \\<=0.5% reduction from Baseline between \\>=Week 12 and \\<Week 24; HbA1c \\>=8.5% between \\>=Week 24 and \\<Week 48; HbA1c \\>=8.0% between \\>= Week 48 and \\<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week'}, {'measure': 'Change From Baseline in Body Weight at Week 104', 'timeFrame': 'Baseline and Week 104', 'description': 'The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.'}, {'measure': 'Change From Baseline in Body Weight at Week 156', 'timeFrame': 'Baseline and Week 156', 'description': 'The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': '112753', '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': '112753', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112753', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112753', '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': '112753', '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': '112753', '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': '112753', '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': '28683300', 'type': 'DERIVED', 'citation': 'Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.'}], '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': 'The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* BMI 20-45kg/m2 inclusive\n\nExclusion Criteria:\n\n* females who are pregnant, lactating or \\<6 weeks post-partum\n* current symptomatic heart failure (NYHA Class III or IV)'}, 'identificationModule': {'nctId': 'NCT00838903', 'briefTitle': 'Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '112753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'albiglutide + metformin', 'description': 'Albiglutide + metformin + placebo sitagliptin + placebo glimepiride', 'interventionNames': ['Biological: albiglutide', 'Drug: metformin', 'Drug: placebo sitagliptin', 'Drug: placebo glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sitagliptin + metformin', 'description': 'Sitagliptin + metformin + placebo albiglutide + placebo glimepiride', 'interventionNames': ['Drug: sitagliptin', 'Drug: metformin', 'Biological: placebo albiglutide', 'Drug: placebo glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'glimepiride + metformin', 'description': 'Glimepiride + metformin + placebo albiglutide + placebo sitagliptin', 'interventionNames': ['Drug: glimepiride', 'Drug: metformin', 'Biological: placebo albiglutide', 'Drug: placebo sitagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metformin + placebo', 'description': 'Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride', 'interventionNames': ['Drug: metformin', 'Biological: placebo albiglutide', 'Drug: placebo sitagliptin', 'Drug: placebo glimepiride']}], 'interventions': [{'name': 'albiglutide', 'type': 'BIOLOGICAL', 'description': 'albiglutide', 'armGroupLabels': ['albiglutide + metformin']}, {'name': 'sitagliptin', 'type': 'DRUG', 'description': 'sitagliptin', 'armGroupLabels': ['sitagliptin + metformin']}, {'name': 'glimepiride', 'type': 'DRUG', 'description': 'Glimepiride', 'armGroupLabels': ['glimepiride + metformin']}, {'name': 'metformin', 'type': 'DRUG', 'description': 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