Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01029704
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2009-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acollinson@theracos.com', 'phone': '(508) 630-2129', 'title': 'Albert Collinson', 'organization': 'Theracos, Inc.'}, 'certainAgreement': {'otherDetails': 'The Investigator does not have the right to publish trial results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)', 'eventGroups': [{'id': 'EG000', 'title': 'Segment 1 (Dose Escalation): EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 once daily for 28 days', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Segment 1 (Dose Escalation): EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 once daily for 28 days', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Segment 1 (Dose Escalation): EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 once daily for 28 days', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Segment 1 (Dose Escalation): EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 once daily for 28 days', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Received no drug (EGT0001442) during 28 days', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 4, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 per day for 28 days', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 per day for 28 days', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 6, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 per day for 28 days', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 6, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 per day for 28 days', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 6, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leucopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Balanitis candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vulvovaginal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Received no drug (EGT0001442) during 28 days'}, {'id': 'OG001', 'title': 'EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 per day for 28 days'}, {'id': 'OG002', 'title': 'EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 per day for 28 days'}, {'id': 'OG003', 'title': 'EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 per day for 28 days'}, {'id': 'OG004', 'title': 'EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 per day for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.595', 'spread': '7.025', 'groupId': 'OG000'}, {'value': '-29.518', 'spread': '7.767', 'groupId': 'OG001'}, {'value': '-30.429', 'spread': '8.386', 'groupId': 'OG002'}, {'value': '-32.586', 'spread': '7.305', 'groupId': 'OG003'}, {'value': '-44.605', 'spread': '7.299', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0989', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.923', 'ciLowerLimit': '-37.076', 'ciUpperLimit': '3.230', 'pValueComment': 'P-values are from two-sided test at 5% level', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.0964', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.834', 'ciLowerLimit': '-38.909', 'ciUpperLimit': '3.242', 'pValueComment': 'P-values are from two-sided test at 5% level', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.0465', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.991', 'ciLowerLimit': '-39.670', 'ciUpperLimit': '-0.312', 'pValueComment': 'P-values are from two-sided test at 5% level', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.0015', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.010', 'ciLowerLimit': '-51.487', 'ciUpperLimit': '-12.533', 'pValueComment': 'P-values are from two-sided test at 5% level', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29', 'description': 'Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects participated in Segment 2 of the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Segment 1 (Dose Escalation): EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 once daily for 28 days'}, {'id': 'OG001', 'title': 'Segment 1 (Dose Escalation): EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 once daily for 28 days'}, {'id': 'OG002', 'title': 'Segment 1 (Dose Escalation): EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 once daily for 28 days'}, {'id': 'OG003', 'title': 'Segment 1 (Dose Escalation): EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '40.42', 'spread': '15.21', 'groupId': 'OG000'}, {'value': '83.38', 'spread': '30.93', 'groupId': 'OG001'}, {'value': '164.20', 'spread': '40.21', 'groupId': 'OG002'}, {'value': '541.20', 'spread': '192.20', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 48 h post-dose', 'description': 'Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2.'}, {'type': 'SECONDARY', 'title': 'Change in the Body Weight From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Received no drug (EGT0001442) during 28 days'}, {'id': 'OG001', 'title': 'EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 per day for 28 days'}, {'id': 'OG002', 'title': 'EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 per day for 28 days'}, {'id': 'OG003', 'title': 'EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 per day for 28 days'}, {'id': 'OG004', 'title': 'EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 per day for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.258', 'spread': '0.304', 'groupId': 'OG000'}, {'value': '-1.176', 'spread': '0.345', 'groupId': 'OG001'}, {'value': '-0.779', 'spread': '0.346', 'groupId': 'OG002'}, {'value': '-1.796', 'spread': '0.324', 'groupId': 'OG003'}, {'value': '-0.914', 'spread': '0.315', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.434', 'ciLowerLimit': '-2.349', 'ciUpperLimit': '-0.520', 'pValueComment': 'P-values are from a two-sided test.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.0269', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.037', 'ciLowerLimit': '-1.952', 'ciUpperLimit': '-0.122', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.054', 'ciLowerLimit': '-2.938', 'ciUpperLimit': '-1.170', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.0090', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.172', 'ciLowerLimit': '-2.044', 'ciUpperLimit': '-0.301', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 29', 'description': 'Changes in the body weight during the study period was calculated by subtracting body weight on day 1 from body weight at the end of treatment on day 29.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects participated in Segment 2 of the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Received no drug (EGT0001442) during 28 days'}, {'id': 'OG001', 'title': 'EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 per day for 28 days'}, {'id': 'OG002', 'title': 'EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 per day for 28 days'}, {'id': 'OG003', 'title': 'EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 per day for 28 days'}, {'id': 'OG004', 'title': 'EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 per day for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.178', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.176', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '0.022', 'spread': '0.123', 'groupId': 'OG002'}, {'value': '0.173', 'spread': '0.115', 'groupId': 'OG003'}, {'value': '-0.167', 'spread': '0.112', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.353', 'ciLowerLimit': '-0.668', 'ciUpperLimit': '-0.039', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.3215', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.155', 'ciLowerLimit': '-0.464', 'ciUpperLimit': '0.154', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.9776', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-0.304', 'ciUpperLimit': '0.295', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.0242', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.344', 'ciLowerLimit': '-0.642', 'ciUpperLimit': '-0.046', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 29', 'description': 'HbA1c levels were measured at two time points; on day 1 and day 29 (end of treatment). Changes in the HbA1c level during the study period was calculated by subtracting HbA1c level on day 1 from HbA1c level at the end of treatment (day 29)', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects participated in Segment 2 of the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Received no drug (EGT0001442) during 28 days'}, {'id': 'OG001', 'title': 'EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 per day for 28 days'}, {'id': 'OG002', 'title': 'EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 per day for 28 days'}, {'id': 'OG003', 'title': 'EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 per day for 28 days'}, {'id': 'OG004', 'title': 'EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 per day for 28 days'}], 'classes': [{'title': 'Change in 24 h UGE from baseline to Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.55', 'spread': '13.05', 'groupId': 'OG000'}, {'value': '26.21', 'spread': '11.08', 'groupId': 'OG001'}, {'value': '24.17', 'spread': '16.89', 'groupId': 'OG002'}, {'value': '25.13', 'spread': '12.72', 'groupId': 'OG003'}, {'value': '29.61', 'spread': '20.00', 'groupId': 'OG004'}]}]}, {'title': 'Change in 24 h UGE from baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '14.98', 'groupId': 'OG000'}, {'value': '22.57', 'spread': '16.56', 'groupId': 'OG001'}, {'value': '18.71', 'spread': '20.46', 'groupId': 'OG002'}, {'value': '21.01', 'spread': '16.43', 'groupId': 'OG003'}, {'value': '26.80', 'spread': '19.36', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 and Day 28', 'description': 'Urinary glucose levels were measured at three time points; on Day 0 (baseline), Day 1 and Day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (Day 1) from urinary glucose level at end of treatment (Day 28) (i.e urinary glucose level on Day 28 minus urinary glucose level on Day 1).', 'unitOfMeasure': 'g/24h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only number of subjects with data available in the specific treatment group is included'}, {'type': 'SECONDARY', 'title': 'Change in FPG Following Cessation of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Received no drug (EGT0001442) during 28 days'}, {'id': 'OG001', 'title': 'EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 per day for 28 days'}, {'id': 'OG002', 'title': 'EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 per day for 28 days'}, {'id': 'OG003', 'title': 'EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 per day for 28 days'}, {'id': 'OG004', 'title': 'EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 per day for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.058', 'spread': '8.256', 'groupId': 'OG000'}, {'value': '17.746', 'spread': '8.896', 'groupId': 'OG001'}, {'value': '17.148', 'spread': '10.421', 'groupId': 'OG002'}, {'value': '24.437', 'spread': '7.989', 'groupId': 'OG003'}, {'value': '20.807', 'spread': '8.021', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.688', 'ciLowerLimit': '-7.210', 'ciUpperLimit': '42.587', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.2079', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.091', 'ciLowerLimit': '-9.696', 'ciUpperLimit': '43.877', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.0410', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.379', 'ciLowerLimit': '1.028', 'ciUpperLimit': '47.731', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}, {'pValue': '0.0862', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.749', 'ciLowerLimit': '-3.019', 'ciUpperLimit': '44.518', 'pValueComment': 'P-values are from a two-sided test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 27/29 to Days 41/43', 'description': 'The mean change in FPG following cessation of treatment was obtained by calculating the difference between FPG values obtained on End of treatment (average of FPG values on days 27 and 29) and on Post Treatment (average of FPG values on days 41 and 43).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects participated in Segment 2 of the study and had fasting plasma glucose (FPG) values at the end of treatment (mean FPG value on days 27 and 29) and at post-treatment (mean FPG values on days 41 and 43) are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Segment 1 (Dose Escalation): EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 once daily for 28 days'}, {'id': 'OG001', 'title': 'Segment 1 (Dose Escalation): EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 once daily for 28 days'}, {'id': 'OG002', 'title': 'Segment 1 (Dose Escalation): EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 once daily for 28 days'}, {'id': 'OG003', 'title': 'Segment 1 (Dose Escalation): EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 once daily for 28 days'}], 'classes': [{'title': 'AUC0-t', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '334.02', 'spread': '51.80', 'groupId': 'OG000'}, {'value': '681.88', 'spread': '74.66', 'groupId': 'OG001'}, {'value': '1312.36', 'spread': '487.28', 'groupId': 'OG002'}, {'value': '3308.88', 'spread': '785.59', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '328.85', 'spread': '56.07', 'groupId': 'OG000'}, {'value': '548.15', 'spread': '70.41', 'groupId': 'OG001'}, {'value': '1076.39', 'spread': '373.15', 'groupId': 'OG002'}, {'value': '2755.68', 'spread': '586.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 48 h post-dose', 'description': 'Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2.\n\nAUC0-24 values for two participants in 5 mg arm were not calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Segment 1 (Dose Escalation): EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 once daily for 28 days'}, {'id': 'FG001', 'title': 'Segment 1 (Dose Escalation): EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 once daily for 28 days'}, {'id': 'FG002', 'title': 'Segment 1 (Dose Escalation): EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 once daily for 28 days'}, {'id': 'FG003', 'title': 'Segment 1 (Dose Escalation): EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 once daily for 28 days'}, {'id': 'FG004', 'title': 'Segment 2 (Double-blind): Placebo', 'description': 'Received placebo once daily for 28 days'}, {'id': 'FG005', 'title': 'Segment 2 (Double-blind): EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 once daily for 28 days'}, {'id': 'FG006', 'title': 'Segment 2 (Double-blind): EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 once daily for 28 days'}, {'id': 'FG007', 'title': 'Segment 2 (Double-blind): EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 once daily for 28 days'}, {'id': 'FG008', 'title': 'Segment 2 (Double-blind): EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 once daily for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '24'}, {'groupId': 'FG006', 'numSubjects': '23'}, {'groupId': 'FG007', 'numSubjects': '28'}, {'groupId': 'FG008', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '22'}, {'groupId': 'FG008', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawn due to major protocol violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '149', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Segment 1 (Dose Escalation): EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 once daily for 28 days'}, {'id': 'BG001', 'title': 'Segment 1 (Dose Escalation): EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 once daily for 28 days'}, {'id': 'BG002', 'title': 'Segment 1 (Dose Escalation): EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 once daily for 28 days'}, {'id': 'BG003', 'title': 'Segment 1 (Dose Escalation): EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 once daily for 28 days'}, {'id': 'BG004', 'title': 'Segment 2 (Double-blind): Placebo', 'description': 'Received placebo once daily for 28 days'}, {'id': 'BG005', 'title': 'Segment 2 (Double-blind): EGT0001442 5mg', 'description': 'Received 5mg of EGT0001442 once daily for 28 days'}, {'id': 'BG006', 'title': 'Segment 2 (Double-blind): EGT0001442 10mg', 'description': 'Received 10mg of EGT0001442 once daily for 28 days'}, {'id': 'BG007', 'title': 'Segment 2 (Double-blind): EGT0001442 20mg', 'description': 'Received 20mg of EGT0001442 once daily for 28 days'}, {'id': 'BG008', 'title': 'Segment 2 (Double-blind): EGT0001442 50mg', 'description': 'Received 50mg of EGT0001442 once daily for 28 days'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Segment 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '62.2', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '49.4', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '51.4', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '53.2', 'spread': '5.8', 'groupId': 'BG003'}, {'value': '54.1', 'spread': '10.8', 'groupId': 'BG009'}]}]}, {'title': 'Segment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '129', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '58.7', 'spread': '7.3', 'groupId': 'BG004'}, {'value': '57.8', 'spread': '6.9', 'groupId': 'BG005'}, {'value': '54.9', 'spread': '9', 'groupId': 'BG006'}, {'value': '59', 'spread': '7.1', 'groupId': 'BG007'}, {'value': '54.7', 'spread': '6.7', 'groupId': 'BG008'}, {'value': '57.1', 'spread': '7.5', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Segment 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '14', 'groupId': 'BG009'}]}]}, {'title': 'Segment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '129', 'groupId': 'BG009'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '62', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '67', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Segment 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}, {'title': 'Segment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '129', 'groupId': 'BG009'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}, {'value': '89', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '40', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Segment 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}, {'title': 'Segment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '129', 'groupId': 'BG009'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}, {'value': '106', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.'}, {'title': 'Height', 'classes': [{'title': 'Segment 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '172.04', 'spread': '11.49', 'groupId': 'BG000'}, {'value': '167.34', 'spread': '11.42', 'groupId': 'BG001'}, {'value': '163.74', 'spread': '9.10', 'groupId': 'BG002'}, {'value': '172.80', 'spread': '9.00', 'groupId': 'BG003'}, {'value': '168.98', 'spread': '10.20', 'groupId': 'BG009'}]}]}, {'title': 'Segment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '129', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '167.76', 'spread': '11.09', 'groupId': 'BG004'}, {'value': '170.15', 'spread': '9.32', 'groupId': 'BG005'}, {'value': '167.50', 'spread': '9.83', 'groupId': 'BG006'}, {'value': '166.71', 'spread': '9.60', 'groupId': 'BG007'}, {'value': '164.92', 'spread': '10.98', 'groupId': 'BG008'}, {'value': '167.36', 'spread': '10.19', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.'}, {'title': 'Weight', 'classes': [{'title': 'Segment 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '91.04', 'spread': '14.48', 'groupId': 'BG000'}, {'value': '83.72', 'spread': '9.86', 'groupId': 'BG001'}, {'value': '92.18', 'spread': '16.65', 'groupId': 'BG002'}, {'value': '87.22', 'spread': '12.81', 'groupId': 'BG003'}, {'value': '88.54', 'spread': '13.01', 'groupId': 'BG009'}]}]}, {'title': 'Segment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '129', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '84.34', 'spread': '15.83', 'groupId': 'BG004'}, {'value': '86.75', 'spread': '13.53', 'groupId': 'BG005'}, {'value': '81.40', 'spread': '15.03', 'groupId': 'BG006'}, {'value': '81.03', 'spread': '12.17', 'groupId': 'BG007'}, {'value': '84.18', 'spread': '17.61', 'groupId': 'BG008'}, {'value': '83.51', 'spread': '14.86', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.'}, {'title': 'BMI', 'classes': [{'title': 'Segment 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '30.58', 'spread': '1.85', 'groupId': 'BG000'}, {'value': '30.00', 'spread': '3.39', 'groupId': 'BG001'}, {'value': '34.18', 'spread': '3.58', 'groupId': 'BG002'}, {'value': '29.14', 'spread': '2.94', 'groupId': 'BG003'}, {'value': '30.98', 'spread': '3.40', 'groupId': 'BG009'}]}]}, {'title': 'Segment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '129', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '29.77', 'spread': '3.03', 'groupId': 'BG004'}, {'value': '29.96', 'spread': '3.98', 'groupId': 'BG005'}, {'value': '28.91', 'spread': '4.02', 'groupId': 'BG006'}, {'value': '29.10', 'spread': '3.30', 'groupId': 'BG007'}, {'value': '30.75', 'spread': '4.47', 'groupId': 'BG008'}, {'value': '29.70', 'spread': '3.77', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-05-17', 'size': 710981, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-31T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2009-12-09', 'resultsFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2009-12-09', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-06-21', 'studyFirstPostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study', 'timeFrame': 'Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29', 'description': 'Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.'}, {'measure': 'Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4', 'timeFrame': 'Pre-dose to 48 h post-dose', 'description': 'Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.'}, {'measure': 'Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4', 'timeFrame': 'Pre-dose to 48 h post-dose', 'description': 'Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.'}], 'secondaryOutcomes': [{'measure': 'Change in the Body Weight From Baseline at Week 4', 'timeFrame': 'Baseline and Day 29', 'description': 'Changes in the body weight during the study period was calculated by subtracting body weight on day 1 from body weight at the end of treatment on day 29.'}, {'measure': 'Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4', 'timeFrame': 'Baseline and Day 29', 'description': 'HbA1c levels were measured at two time points; on day 1 and day 29 (end of treatment). Changes in the HbA1c level during the study period was calculated by subtracting HbA1c level on day 1 from HbA1c level at the end of treatment (day 29)'}, {'measure': 'Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28', 'timeFrame': 'Baseline, Day 1 and Day 28', 'description': 'Urinary glucose levels were measured at three time points; on Day 0 (baseline), Day 1 and Day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (Day 1) from urinary glucose level at end of treatment (Day 28) (i.e urinary glucose level on Day 28 minus urinary glucose level on Day 1).'}, {'measure': 'Change in FPG Following Cessation of Treatment', 'timeFrame': 'Days 27/29 to Days 41/43', 'description': 'The mean change in FPG following cessation of treatment was obtained by calculating the difference between FPG values obtained on End of treatment (average of FPG values on days 27 and 29) and on Post Treatment (average of FPG values on days 41 and 43).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus Type 2'], 'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.\n\nThe study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.', 'detailedDescription': 'This was a phase 2 study to evaluate the efficacy of\n\nEGT0001442. The study included two segments:\n\nSegment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.\n\nSegment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.\n* Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).\n* HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.\n* Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.\n* Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).\n* If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.\n* Female subjects must be surgically sterilized or postmenopausal.\n\nExclusion Criteria:\n\n* Type 1 diabetes or diabetes treated with insulin injection.\n* Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.\n* Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.\n* Positive results on screen for drugs of abuse.\n* Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.\n* Previous treatment with EGT0001474 or EGT0001442.'}, 'identificationModule': {'nctId': 'NCT01029704', 'briefTitle': 'Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theracos'}, 'officialTitle': 'A Phase II, Four-week, Multi-center, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Safety and Efficacy of EGT0001442 in Subjects With Type 2 Diabetes Mellitus With an Ascending Dose Safety and Pharmacokinetic Evaluation Period', 'orgStudyIdInfo': {'id': 'THR-1442-C-402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EGT0001442', 'interventionNames': ['Drug: EGT0001442']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo capsules to match EGT0001442']}], 'interventions': [{'name': 'EGT0001442', 'type': 'DRUG', 'otherNames': ['Human SGLT2 inhibitor'], 'description': 'Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.\n\nSegment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.', 'armGroupLabels': ['EGT0001442']}, {'name': 'Placebo capsules to match EGT0001442', 'type': 'DRUG', 'otherNames': ['Human SGLT2 inhibitor'], 'description': 'Segment 1: Not applicable.\n\nSegment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site #10', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Research Site #04', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site #12', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site #07', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site #08', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site #06', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site #11', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site #01', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site #15', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site #03', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site #13', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site #02', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'Mason W Freeman, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theracos', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}