Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-04-11 @ 8:11 AM
Study NCT ID:
NCT01869959
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2013-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY2405319 in Participants With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585266', 'term': 'LY2405319'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.', 'otherNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.', 'otherNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.', 'otherNumAtRisk': 15, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 39, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 46, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Day 56', 'description': 'The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-19.2', 'upperLimit': '12.2'}, {'value': '-6.7', 'groupId': 'OG001', 'lowerLimit': '-24.4', 'upperLimit': '11.0'}, {'value': '-10.5', 'groupId': 'OG002', 'lowerLimit': '-24.3', 'upperLimit': '3.4'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '-14.1', 'upperLimit': '20.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in fasting blood glucose is presented. The predose fasting blood glucose measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug with evaluable blood glucose data.'}, {'type': 'SECONDARY', 'title': '7 Point Self-monitored Blood Glucose (SMBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'title': 'Baseline (Days -6, -5, or -4)', 'categories': [{'measurements': [{'value': '178.01', 'spread': '5.95', 'groupId': 'OG000'}, {'value': '171.13', 'spread': '5.02', 'groupId': 'OG001'}, {'value': '183.97', 'spread': '4.19', 'groupId': 'OG002'}, {'value': '172.46', 'spread': '5.33', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (Days 24, 25, or 26)', 'categories': [{'measurements': [{'value': '171.03', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '167.95', 'spread': '8.09', 'groupId': 'OG001'}, {'value': '188.52', 'spread': '7.14', 'groupId': 'OG002'}, {'value': '177.41', 'spread': '7.24', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26)', 'description': 'The daily mean of the 7-point SMBG values is presented. Seven-point glucose profiles were measured by participants at baseline and at Week 4. The 7-point SMBG mean on Days -5, -4, or -3 served as the baseline value; the 7-point SMBG mean on Days 24, 25, or 26 served as the Week 4 value. Blood glucose was measured before and 2 hours after each meal and at bedtime.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable 7-Point SMBG data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.89', 'groupId': 'OG000', 'lowerLimit': '-36.21', 'upperLimit': '61.98'}, {'value': '-8.46', 'groupId': 'OG001', 'lowerLimit': '-66.69', 'upperLimit': '49.76'}, {'value': '-3.22', 'groupId': 'OG002', 'lowerLimit': '-51.94', 'upperLimit': '45.49'}, {'value': '-28.13', 'groupId': 'OG003', 'lowerLimit': '-83.13', 'upperLimit': '26.87'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Predose and 2 hours postdose (Baseline, Week 4)', 'description': 'Change from baseline to Week 4 in glucose AUC during an oral glucose tolerance test (OGTT) is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.', 'unitOfMeasure': 'milligrams*hr per deciliter (mg*hr/dL)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable glucose AUC data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.07', 'groupId': 'OG000', 'lowerLimit': '-20.40', 'upperLimit': '0.26'}, {'value': '-10.37', 'groupId': 'OG001', 'lowerLimit': '-23.11', 'upperLimit': '2.36'}, {'value': '-15.66', 'groupId': 'OG002', 'lowerLimit': '-25.11', 'upperLimit': '-6.21'}, {'value': '-17.98', 'groupId': 'OG003', 'lowerLimit': '-29.54', 'upperLimit': '-6.42'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Predose and 2 hours postdose (Baseline, Week 4)', 'description': 'Change from baseline to Week 4 in insulin AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.', 'unitOfMeasure': 'micro International units*hour/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable insulin (AUC) data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.61', 'groupId': 'OG000', 'lowerLimit': '-1.58', 'upperLimit': '0.36'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '-1.03', 'upperLimit': '1.17'}, {'value': '-1.39', 'groupId': 'OG002', 'lowerLimit': '-2.27', 'upperLimit': '-0.51'}, {'value': '-1.59', 'groupId': 'OG003', 'lowerLimit': '-2.66', 'upperLimit': '-0.51'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Predose and 2 hours postdose (Baseline, Week 4)', 'description': 'Change from baseline to Week 4 in C-peptide AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as a fixed effect and baseline as covariate.', 'unitOfMeasure': 'nanograms*hours/milliliter (ng*hr/mL)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable C-peptide AUC data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Fasting Lipid Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'title': 'Cholesterol (n=10, n=8, n=13, n=8)', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '14.6'}, {'value': '-32.5', 'groupId': 'OG001', 'lowerLimit': '-44.5', 'upperLimit': '-20.6'}, {'value': '-31.4', 'groupId': 'OG002', 'lowerLimit': '-40.7', 'upperLimit': '-22.0'}, {'value': '-1.3', 'groupId': 'OG003', 'lowerLimit': '-13.0', 'upperLimit': '10.4'}]}]}, {'title': 'LDL-C (n=10, n=8, n=13, n=7)', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-10.5', 'upperLimit': '10.3'}, {'value': '-26.8', 'groupId': 'OG001', 'lowerLimit': '-38.6', 'upperLimit': '-14.9'}, {'value': '-24.2', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '-15.1'}, {'value': '-0.8', 'groupId': 'OG003', 'lowerLimit': '-13.1', 'upperLimit': '11.5'}]}]}, {'title': 'HDL-C (n=10, n=8, n=13, n=8)', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '14.0'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '14.1'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '12.1'}, {'value': '-0.8', 'groupId': 'OG003', 'lowerLimit': '-4.7', 'upperLimit': '3.1'}]}]}, {'title': 'Triglycerides (n=10, n=8, n=13, n=8)', 'categories': [{'measurements': [{'value': '-38.5', 'groupId': 'OG000', 'lowerLimit': '-62.9', 'upperLimit': '-14.1'}, {'value': '-81.0', 'groupId': 'OG001', 'lowerLimit': '-107.3', 'upperLimit': '-54.8'}, {'value': '-84.4', 'groupId': 'OG002', 'lowerLimit': '-105.0', 'upperLimit': '-63.8'}, {'value': '6.8', 'groupId': 'OG003', 'lowerLimit': '-21.2', 'upperLimit': '34.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in fasting lipids, including cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides is presented. The predose measurement for each variable on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable fasting lipid (ie, cholesterol, LDL-C, HDL-C, and triglyceride) data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '0.3'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '-0.6'}, {'value': '-1.5', 'groupId': 'OG002', 'lowerLimit': '-2.3', 'upperLimit': '-0.7'}, {'value': '-0.2', 'groupId': 'OG003', 'lowerLimit': '-1.3', 'upperLimit': '0.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in body weight is presented. The predose body weight measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, time, and treatment times time, treatment times day, and treatment times day times time were fixed effects; baseline as covariate; and participant as a random effect.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable body weight data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Adiponectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1850.7', 'groupId': 'OG000', 'lowerLimit': '405.1', 'upperLimit': '3296.3'}, {'value': '2907.1', 'groupId': 'OG001', 'lowerLimit': '1289.1', 'upperLimit': '4525.1'}, {'value': '5648.6', 'groupId': 'OG002', 'lowerLimit': '4345.2', 'upperLimit': '6952.1'}, {'value': '458.3', 'groupId': 'OG003', 'lowerLimit': '-1165.1', 'upperLimit': '2081.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in adiponectin is presented. The predose adiponectin measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, treatment times day as fixed effects, baseline as covariate, and participant as random effect.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable adiponectin data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '1.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '2.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-1.6', 'upperLimit': '1.7'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '-1.8', 'upperLimit': '2.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in C-reactive protein is presented. The predose C-reactive protein measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as random effect.', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable C-reactive protein data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '409', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '1520', 'spread': '38.9', 'groupId': 'OG001'}, {'value': '3410', 'spread': '35.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose through Day 28 (48 hours postdose)', 'description': 'AUC for LY2405319 is presented. Data represent AUC for 1 dosing interval at steady state. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.', 'unitOfMeasure': 'nanograms*hours/milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable AUC of LY2405319 data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '34.7', 'groupId': 'OG000'}, {'value': '105', 'spread': '62.9', 'groupId': 'OG001'}, {'value': '247', 'spread': '58.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose through Day 28 (48 hours postdose)', 'description': 'Cmax of LY2405319 is presented. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable Cmax of LY2405319 data.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Anti-LY2405319 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 56', 'description': 'The number of participants that tested positive for anti-LY2405319 antibodies is presented.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable anti-LY2405319 antibody data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'title': 'Cognitive restraint of eating', 'categories': [{'measurements': [{'value': '-1.10', 'groupId': 'OG000', 'lowerLimit': '-2.68', 'upperLimit': '0.48'}, {'value': '-0.35', 'groupId': 'OG001', 'lowerLimit': '-2.09', 'upperLimit': '1.39'}, {'value': '-0.27', 'groupId': 'OG002', 'lowerLimit': '-1.71', 'upperLimit': '1.17'}, {'value': '-2.99', 'groupId': 'OG003', 'lowerLimit': '-4.73', 'upperLimit': '-1.25'}]}]}, {'title': 'Disinhibition', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '1.34'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '-1.06', 'upperLimit': '1.15'}, {'value': '-1.59', 'groupId': 'OG002', 'lowerLimit': '-2.47', 'upperLimit': '-0.70'}, {'value': '0.04', 'groupId': 'OG003', 'lowerLimit': '-1.06', 'upperLimit': '1.14'}]}]}, {'title': 'Hunger', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '2.32'}, {'value': '2.05', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '3.50'}, {'value': '0.53', 'groupId': 'OG002', 'lowerLimit': '-0.65', 'upperLimit': '1.70'}, {'value': '0.29', 'groupId': 'OG003', 'lowerLimit': '-1.16', 'upperLimit': '1.73'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in Eating Inventory (EI) subscales are presented. The EI is a 51-item inventory that measures dietary restraint (the cognitive intention to restrict energy intake; scores range from 0 to 21), disinhibition (the tendency to episodically overeat, often in response to external cues; scores range from 0 to 16), and perceived hunger (scores range from 0 to 14). A low score indicates a low exhibition of behavior and a high score indicates a high exhibition of behavior. The measurement for each variable obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable EI data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '0.61'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-1.15', 'upperLimit': '0.29'}, {'value': '-0.77', 'groupId': 'OG002', 'lowerLimit': '-1.30', 'upperLimit': '-0.24'}, {'value': '0.74', 'groupId': 'OG003', 'lowerLimit': '0.09', 'upperLimit': '1.40'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'The table below represents the change from baseline in FPQ total score. The FPQ was administered to assess overall preference for foods of different macronutrient contents utilizing a macronutrient self-selection paradigm. Participants rated their preference on a range from 1 to 9 with 1 (dislike extremely) to 9 (like extremely) for a battery of 72 commonly consumed foods with fat content varying significantly in sugar, complex carbohydrates, and protein. The total score was calculated by averaging preference scores of 72 items. A low mean score of 1 to 9 scale indicate a low preference for the foods listed and a high mean score indicate a high preference for the foods listed. The FPQ measurement on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable FPQ data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg LY2405319', 'description': 'Participants received 3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG001', 'title': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG002', 'title': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected SC once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '-0.71', 'upperLimit': '3.24'}, {'value': '-0.50', 'groupId': 'OG001', 'lowerLimit': '-2.83', 'upperLimit': '1.82'}, {'value': '1.82', 'groupId': 'OG002', 'lowerLimit': '0.08', 'upperLimit': '3.56'}, {'value': '2.57', 'groupId': 'OG003', 'lowerLimit': '0.43', 'upperLimit': '4.71'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in the PHQ-9 total score is presented. Participants were asked to score the severity of depressive symptoms over the last 2 weeks. Items were scored 0 (not at all), 1 (several days), 2 (half of the days), or 3 (nearly every day). The total PHQ-9 score is the sum of the score for each item and range from 0 to 27. A score of 0 means low depression severity and a score of 27 means high depression severity. Depression severity will be given a quality rating based on the total PHQ-9 score, as follows: None (0-4); Mild (5-9); Moderate (10-14); Moderately severe (15-19); and Severe (20-27). The PHQ-9 measurement obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug with evaluable PHQ-9 data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3 mg LY2405319', 'description': '3 milligrams (mg) LY2405319 injected SC once daily for 28 days.'}, {'id': 'FG001', 'title': '10 mg LY2405319', 'description': '10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'FG002', 'title': '20 mg LY2405319', 'description': '20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.'}, {'id': 'FG004', 'title': 'All Randomized Participants', 'description': 'All participants randomized in the study.'}], 'periods': [{'title': 'Randomization Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'One participant discontinued after randomization but did not receive study drug.', 'groupId': 'FG004', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'comment': 'Participants were randomized to treatment groups for the Treatment Period.', 'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '3 mg LY2405319', 'description': '3 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'BG001', 'title': '10 mg LY2405319', 'description': '10 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'BG002', 'title': '20 mg LY2405319', 'description': '20 mg LY2405319 injected SC once daily for 28 days.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '58.6', 'spread': '6.3', 'groupId': 'BG003'}, {'value': '57.7', 'spread': '8.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2013-05-31', 'resultsFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2013-05-31', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-27', 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Day 56', 'description': 'The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Day 28 in Fasting Glucose', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in fasting blood glucose is presented. The predose fasting blood glucose measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.'}, {'measure': '7 Point Self-monitored Blood Glucose (SMBG)', 'timeFrame': 'Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26)', 'description': 'The daily mean of the 7-point SMBG values is presented. Seven-point glucose profiles were measured by participants at baseline and at Week 4. The 7-point SMBG mean on Days -5, -4, or -3 served as the baseline value; the 7-point SMBG mean on Days 24, 25, or 26 served as the Week 4 value. Blood glucose was measured before and 2 hours after each meal and at bedtime.'}, {'measure': 'Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC)', 'timeFrame': 'Predose and 2 hours postdose (Baseline, Week 4)', 'description': 'Change from baseline to Week 4 in glucose AUC during an oral glucose tolerance test (OGTT) is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.'}, {'measure': 'Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC)', 'timeFrame': 'Predose and 2 hours postdose (Baseline, Week 4)', 'description': 'Change from baseline to Week 4 in insulin AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.'}, {'measure': 'Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC)', 'timeFrame': 'Predose and 2 hours postdose (Baseline, Week 4)', 'description': 'Change from baseline to Week 4 in C-peptide AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as a fixed effect and baseline as covariate.'}, {'measure': 'Change From Baseline to Day 28 in Fasting Lipid Profile', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in fasting lipids, including cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides is presented. The predose measurement for each variable on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.'}, {'measure': 'Change From Baseline to Day 28 in Body Weight', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in body weight is presented. The predose body weight measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, time, and treatment times time, treatment times day, and treatment times day times time were fixed effects; baseline as covariate; and participant as a random effect.'}, {'measure': 'Change From Baseline to Day 28 in Adiponectin', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in adiponectin is presented. The predose adiponectin measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, treatment times day as fixed effects, baseline as covariate, and participant as random effect.'}, {'measure': 'Change From Baseline to Day 28 in C-Reactive Protein', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in C-reactive protein is presented. The predose C-reactive protein measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as random effect.'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319', 'timeFrame': 'Predose through Day 28 (48 hours postdose)', 'description': 'AUC for LY2405319 is presented. Data represent AUC for 1 dosing interval at steady state. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319', 'timeFrame': 'Predose through Day 28 (48 hours postdose)', 'description': 'Cmax of LY2405319 is presented. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.'}, {'measure': 'The Number of Participants With Anti-LY2405319 Antibodies', 'timeFrame': 'Day 1 through Day 56', 'description': 'The number of participants that tested positive for anti-LY2405319 antibodies is presented.'}, {'measure': 'Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in Eating Inventory (EI) subscales are presented. The EI is a 51-item inventory that measures dietary restraint (the cognitive intention to restrict energy intake; scores range from 0 to 21), disinhibition (the tendency to episodically overeat, often in response to external cues; scores range from 0 to 16), and perceived hunger (scores range from 0 to 14). A low score indicates a low exhibition of behavior and a high score indicates a high exhibition of behavior. The measurement for each variable obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.'}, {'measure': 'Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score', 'timeFrame': 'Baseline, Day 28', 'description': 'The table below represents the change from baseline in FPQ total score. The FPQ was administered to assess overall preference for foods of different macronutrient contents utilizing a macronutrient self-selection paradigm. Participants rated their preference on a range from 1 to 9 with 1 (dislike extremely) to 9 (like extremely) for a battery of 72 commonly consumed foods with fat content varying significantly in sugar, complex carbohydrates, and protein. The total score was calculated by averaging preference scores of 72 items. A low mean score of 1 to 9 scale indicate a low preference for the foods listed and a high mean score indicate a high preference for the foods listed. The FPQ measurement on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.'}, {'measure': 'Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score', 'timeFrame': 'Baseline, Day 28', 'description': 'Change from baseline to Day 28 in the PHQ-9 total score is presented. Participants were asked to score the severity of depressive symptoms over the last 2 weeks. Items were scored 0 (not at all), 1 (several days), 2 (half of the days), or 3 (nearly every day). The total PHQ-9 score is the sum of the score for each item and range from 0 to 27. A score of 0 means low depression severity and a score of 27 means high depression severity. Depression severity will be given a quality rating based on the total PHQ-9 score, as follows: None (0-4); Mild (5-9); Moderate (10-14); Moderately severe (15-19); and Severe (20-27). The PHQ-9 measurement obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It was given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study determined how long the drug stays in the body and how it affects blood sugar levels. After screening, the study lasted about 2 months for each participant. Participants continued their prestudy regimen of diet and exercise alone or in combination with metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a diagnosis of T2DM.\n* Are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days) regimen.\n* Have a glycosylated hemoglobin A1c (HbA1c) value of 7.0% to 10.0%, inclusive, or are on metformin and an additional oral antidiabetic medication (OAM) with an HbA1c value of 6.5% to 9.5%, inclusive.\n* Participants on another OAM in addition to metformin therapy may be randomized if removed from treatment of the other OAM ≥14 days prior to study drug administration and fasting blood glucose is ≥145 mg per deciliter (mg/dL) and ≤270 mg/dL.\n* Are females not of child-bearing potential due to surgical sterilization or are postmenopausal.\n* Have a body mass index (BMI) ≥25 and ≤40.\n* Have clinical laboratory test results within normal reference range for the population.\n\nExclusion Criteria:\n\n* Use insulin, thiazolidinediones (TZDs), dipeptidyl peptidase (DPP) IV inhibitors, or exenatide during the 3 months prior to screening.\n* Have had more than 1 episode of severe hypoglycemia requiring assistance of another person to administer a resuscitative action within 6 months prior to entry into the study or are currently diagnosed with having hypoglycemia unawareness.\n* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.\n* Have any abnormality of the electrocardiogram (ECG) that will, in the opinion of the investigator, impair the ability to measure the QT (a corrected QC \\[QTc\\] \\[Bazett's correction\\] interval \\>450 milliseconds \\[msec\\] for men and \\>470 msec for women or a PR interval \\>220 msec are specifically excluded) or have conduction abnormalities that may confound the QTc analysis.\n* Have a personal or family history of long QT syndrome, family history of sudden death, personal history of unexplained syncope within the last year; or use prescription or over-the-counter medications known to prolong the QT or QTc interval.\n* Have diastolic blood pressure (DBP) ≥95 millimeters of mercury (mm Hg) and/or systolic blood pressure (SBP) ≥160 mm Hg.\n* Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for \\<5 years.\n* Have a history of a transplanted organ.\n* Evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator, at screening.\n* Have a history of human immunodeficiency virus (HIV).\n* Have a known allergy to yeast or yeast proteins, history of anaphylaxis with bronchospasm, or atopic dermatitis with chronic urticaria.\n* Have any other condition (including known drug or alcohol abuse or psychiatric disorder within the last 6 months) that may preclude the participant from following and completing the protocol.\n* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (including pancreatitis), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.\n* Are women who are breastfeeding.\n* Have had a significant change in weight, defined as a gain or loss of at least 4 kilograms (kg) (9 pounds) in the 90 days prior to randomization.\n* Have taken in the 30 days prior to randomization, a medication, herbal product, or nutritional supplement that affects adipose mass or distribution or energy balance.\n* Are receiving chronic (\\>2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to second screening appointment.\n* Have current or recent (within the past 3 months) use of gemfibrozil or fenofibrate, niacin, ezetimibe, or bile acid binding resins (for example, cholestyramines). Stable statin therapy of ≥3 months will be allowed.\n* Are currently taking central nervous system (CNS) stimulant."}, 'identificationModule': {'nctId': 'NCT01869959', 'briefTitle': 'A Study of LY2405319 in Participants With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2405319 With 28 Days of Subcutaneous Injections in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '12708'}, 'secondaryIdInfos': [{'id': 'I1K-MC-GLUG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3 mg LY2405319', 'description': 'Participants received 3 milligrams (mg) LY2405319 injected SC once daily for 28 days.', 'interventionNames': ['Drug: LY2405319']}, {'type': 'EXPERIMENTAL', 'label': '10 mg LY2405319', 'description': 'Participants received 10 mg LY2405319 injected SC once daily for 28 days.', 'interventionNames': ['Drug: LY2405319']}, {'type': 'EXPERIMENTAL', 'label': '20 mg LY2405319', 'description': 'Participants received 20 mg LY2405319 injected SC once daily for 28 days.', 'interventionNames': ['Drug: LY2405319']}], 'interventions': [{'name': 'LY2405319', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['10 mg LY2405319', '20 mg LY2405319', '3 mg LY2405319']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}