Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03214367
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2017-07-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY900014 in Participants With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'C571886', 'term': 'insulin degludec'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 56 Weeks', 'description': 'All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Lispro (Humalog) Lead-in', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'otherNumAtRisk': 1316, 'deathsNumAtRisk': 1316, 'otherNumAffected': 131, 'seriousNumAtRisk': 1316, 'deathsNumAffected': 0, 'seriousNumAffected': 48}, {'id': 'EG001', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'otherNumAtRisk': 442, 'deathsNumAtRisk': 442, 'otherNumAffected': 147, 'seriousNumAtRisk': 442, 'deathsNumAffected': 1, 'seriousNumAffected': 67}, {'id': 'EG002', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'otherNumAtRisk': 451, 'deathsNumAtRisk': 451, 'otherNumAffected': 163, 'seriousNumAtRisk': 451, 'deathsNumAffected': 1, 'seriousNumAffected': 54}, {'id': 'EG003', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.', 'otherNumAtRisk': 329, 'deathsNumAtRisk': 329, 'otherNumAffected': 104, 'seriousNumAtRisk': 329, 'deathsNumAffected': 1, 'seriousNumAffected': 30}, {'id': 'EG004', 'title': 'Insulin Lispro (Humalog) Lead-in-MEE', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 5, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Insulin Lispro (Humalog)-MEE', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 13, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG006', 'title': 'LY900014-MEE', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 3, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'LY900014 Postmeal-MEE', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 87, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 123, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 161, 'numAffected': 106}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 85, 'numAffected': 66}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 43, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Maternal exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperemesis gravidarum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Placenta praevia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Retroplacental haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vasectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 0, 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'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 442, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '417', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.031', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.00', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority margin = 0.4% for HbA1c'}, {'pValue': '0.003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.22', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority margin = 0.4% for HbA1c'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.\n\nLeast Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post-baseline HbA1c data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}, {'value': '390', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.6', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '3.74', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '3.34', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.9', 'ciLowerLimit': '-35.3', 'ciUpperLimit': '-20.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.2', 'ciLowerLimit': '5.0', 'ciUpperLimit': '21.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. 1-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.7', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '5.04', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '4.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.2', 'ciLowerLimit': '-41.1', 'ciUpperLimit': '-21.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.235', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-17.6', 'ciUpperLimit': '4.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. 2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Rate of Severe Hypoglycemia at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '442', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.50', 'groupId': 'OG000'}, {'value': '13.70', 'groupId': 'OG001'}, {'value': '18.34', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 26', 'description': 'Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group \\*36525.', 'unitOfMeasure': 'Events per 100 participant years', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Rate of Documented Symptomatic Hypoglycemia at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '442', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.71', 'spread': '0.479', 'groupId': 'OG000'}, {'value': '7.75', 'spread': '0.582', 'groupId': 'OG001'}, {'value': '7.35', 'spread': '0.697', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Week 26', 'description': 'Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of \\<54 mg/dL \\[3.0 millimole per liter (mmol/L)\\]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.', 'unitOfMeasure': 'Events per participant per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}, {'value': '417', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.124', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.109', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': '1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'milligram per liter (mg/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post-baseline 1,5-AG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'title': 'Morning Premeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '3.19', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '2.84', 'groupId': 'OG002'}]}]}, {'title': 'Morning 1-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.8', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '3.71', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '3.31', 'groupId': 'OG002'}]}]}, {'title': 'Morning 2-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '292', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.1', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '3.63', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '3.22', 'groupId': 'OG002'}]}]}, {'title': 'Midday Premeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.17', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'Midday 1-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '3.81', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '3.40', 'groupId': 'OG002'}]}]}, {'title': 'Midday 2-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '288', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '3.28', 'groupId': 'OG002'}]}]}, {'title': 'Evening Premeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.64', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '3.24', 'groupId': 'OG002'}]}]}, {'title': 'Evening 1-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '3.95', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '3.57', 'groupId': 'OG002'}]}]}, {'title': 'Evening 2-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.2', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '3.83', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '3.45', 'groupId': 'OG002'}]}]}, {'title': 'Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '4.08', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '3.56', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post-baseline SMBG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin Dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'title': 'Total Daily Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '0.73', 'groupId': 'OG002'}]}]}, {'title': 'Daily Basal Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '371', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.29', 'groupId': 'OG002'}]}]}, {'title': 'Daily Prandial Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.60', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'Units (U)/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post-baseline basal insulin dose data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '423', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.91', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '423', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.07', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the LOCF method to the post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c <7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '442', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG002', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.00', 'groupId': 'OG000'}, {'value': '24.84', 'groupId': 'OG001'}, {'value': '33.94', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post-baseline HbA1c \\<7% data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'OG001', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.037', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.184', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.\n\nLeast Squares (LS) mean was determined by MMRM model with variables of baseline, pooled country, type of basal insulin during lead-in, prandial Insulin Dosing Plan, treatment (Type III sum of squares) as fixed factors. The analysis included data prior to permanent discontinuation of study drug.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one postbaseline observation for HbA1c. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. Only double blind arms analysed for this outcome because open label group ended at week 26.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Lispro (Humalog) Lead-in', 'description': '100 units per milliliter (U/mL) Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'FG001', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'FG002', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'FG003', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'FG004', 'title': 'Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'FG005', 'title': 'Insulin Lispro (Humalog)- Maximum Extended Enrollment (MEE)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'FG006', 'title': 'LY900014-MEE', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'FG007', 'title': 'LY900014 Postmeal-MEE', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}], 'periods': [{'title': 'Lead-in Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1316'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '76'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1222'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '74'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Treatment Interruption', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants received Insulin Lispro during Lead-in Period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants were randomized to either LY900014 or Insulin lispro in Treatment Period.', 'groupId': 'FG001', 'numSubjects': '442'}, {'comment': 'Participants were randomized to either LY900014 or Insulin lispro in Treatment Period.', 'groupId': 'FG002', 'numSubjects': '451'}, {'comment': 'Participants were randomized to either LY900014 or Insulin lispro in Treatment Period.', 'groupId': 'FG003', 'numSubjects': '329'}, {'comment': 'Participants received Insulin Lispro during Lead-in Period.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Participants were randomized to either LY900014 or Insulin lispro in Treatment Period.', 'groupId': 'FG005', 'numSubjects': '31'}, {'comment': 'Participants were randomized to either LY900014 or Insulin lispro in Treatment Period.', 'groupId': 'FG006', 'numSubjects': '21'}, {'comment': 'Participants were randomized to either LY900014 or Insulin lispro in Treatment Period.', 'groupId': 'FG007', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '408'}, {'groupId': 'FG002', 'numSubjects': '418'}, {'groupId': 'FG003', 'numSubjects': '310'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '28'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study consists of 2 double-blind arms (LY900014 and Insulin Lispro (Humalog)) and one Open-label treatment group (LY900014 Postmeal).\n\nDouble-blind group: The study included 8-week lead-in period followed by a 52-week treatment period.\n\nOpen-label treatment group: The treatment period ended after 26 weeks.', 'preAssignmentDetails': 'The purpose of the Lead-in Period was to titrate basal insulin prior to randomization. Participants were then randomized to either LY900014 at mealtime, Insulin Lispro (Humalog) at mealtime, or LY900014 administered 20 minutes after the start of a meal (LY900014 Postmeal) in the treatment period (Period 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '1296', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Lispro (Humalog)', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'BG001', 'title': 'LY900014', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'BG002', 'title': 'LY900014 Postmeal', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'BG003', 'title': 'Insulin Lispro (Humalog)-MEE', 'description': '100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'BG004', 'title': 'LY900014-MEE', 'description': '100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'BG005', 'title': 'LY900014 Postmeal-MEE', 'description': '100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '44.1', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '44.5', 'spread': '14.3', 'groupId': 'BG002'}, {'value': '32.1', 'spread': '12.3', 'groupId': 'BG003'}, {'value': '32.4', 'spread': '12.4', 'groupId': 'BG004'}, {'value': '31.5', 'spread': '12.7', 'groupId': 'BG005'}, {'value': '43.7', 'spread': '14.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '570', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '726', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '132', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '397', 'groupId': 'BG000'}, {'value': '399', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '1121', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '266', 'groupId': 'BG006'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '344', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '976', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '361', 'groupId': 'BG006'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '167', 'groupId': 'BG006'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '52', 'groupId': 'BG006'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '123', 'groupId': 'BG006'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '46', 'groupId': 'BG006'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.33', 'spread': '0.67', 'groupId': 'BG000'}, {'value': '7.34', 'spread': '0.65', 'groupId': 'BG001'}, {'value': '7.36', 'spread': '0.64', 'groupId': 'BG002'}, {'value': '7.52', 'spread': '0.99', 'groupId': 'BG003'}, {'value': '7.28', 'spread': '0.67', 'groupId': 'BG004'}, {'value': '7.60', 'spread': '0.62', 'groupId': 'BG005'}, {'value': '7.35', 'spread': '0.66', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-22', 'size': 1889190, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-27T02:52', 'hasProtocol': True}, {'date': '2018-08-14', 'size': 1458785, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-27T03:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2019-09-02', 'completionDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-17', 'studyFirstSubmitDate': '2017-07-10', 'dispFirstSubmitQcDate': '2019-09-02', 'resultsFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2017-07-10', 'dispFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-17', 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.\n\nLeast Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. 1-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.'}, {'measure': 'Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. 2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.'}, {'measure': 'Rate of Severe Hypoglycemia at Week 26', 'timeFrame': 'Baseline through Week 26', 'description': 'Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group \\*36525.'}, {'measure': 'Rate of Documented Symptomatic Hypoglycemia at Week 26', 'timeFrame': 'Baseline through Week 26', 'description': 'Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of \\<54 mg/dL \\[3.0 millimole per liter (mmol/L)\\]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.'}, {'measure': 'Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': '1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.'}, {'measure': 'Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.'}, {'measure': 'Change From Baseline in Insulin Dose at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug.'}, {'measure': 'Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.'}, {'measure': 'Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.'}, {'measure': 'Percentage of Participants With HbA1c <7%', 'timeFrame': 'Week 26', 'description': 'Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.'}, {'measure': 'Change From Baseline in HbA1c at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.\n\nLeast Squares (LS) mean was determined by MMRM model with variables of baseline, pooled country, type of basal insulin during lead-in, prandial Insulin Dosing Plan, treatment (Type III sum of squares) as fixed factors. The analysis included data prior to permanent discontinuation of study drug.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '38035641', 'type': 'DERIVED', 'citation': 'Piras de Oliveira C, Dellva MA, Bue-Valleskey J, Chang AM, Liao B. Fasting and postprandial plasma glucose contributions to hemoglobin A1c and time in range in people with diabetes on multiple daily injection insulin therapy: Results from the PRONTO-T1D and PRONTO-T2D clinical trials. J Diabetes Complications. 2024 Jan;38(1):108648. doi: 10.1016/j.jdiacomp.2023.108648. Epub 2023 Nov 16.'}, {'pmid': '34347267', 'type': 'DERIVED', 'citation': 'Miura J, Nishiyama H, Imori M. Long-term Efficacy and Safety of Ultra Rapid Lispro in Japanese Patients With Type 1 Diabetes: Subpopulation Analysis of the 52-Week PRONTO-T1D Study. Diabetes Ther. 2021 Sep;12(9):2471-2484. doi: 10.1007/s13300-021-01124-9. Epub 2021 Aug 4.'}, {'pmid': '33458803', 'type': 'DERIVED', 'citation': 'Bue-Valleskey J, Klaff L, Cho JI, Dellva MA, Schloot NC, Tobian J, Miura J, Dahl D. Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension. Diabetes Ther. 2021 Feb;12(2):569-580. doi: 10.1007/s13300-020-00987-8. Epub 2021 Jan 17.'}, {'pmid': '32728832', 'type': 'DERIVED', 'citation': 'Miura J, Imori M, Nishiyama H, Imaoka T. Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog(R) in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis. Diabetes Ther. 2020 Sep;11(9):2089-2104. doi: 10.1007/s13300-020-00892-0. Epub 2020 Jul 29.'}], 'seeAlsoLinks': [{'url': 'https://www.lillytrialguide.com/en-US/studies/type-1-diabetes/ITRM#?postal=', 'label': 'A Study of LY900014 in Participants With Type 1 Diabetes (PRONTO-T1D)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.\n* HbA1c of ≥7.0 and ≤9.5%.\n* Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.\n* Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.\n\nExclusion Criteria:\n\n* Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.\n* Have had more than 1 severe hypoglycemic episode within 6 months of screening.\n* Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.\n* Have clinically significant gastrointestinal disease.'}, 'identificationModule': {'nctId': 'NCT03214367', 'acronym': 'PRONTO-T1D', 'briefTitle': 'A Study of LY900014 in Participants With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro With an Open-Label Postprandial LY900014 Treatment Group, in Combination With Insulin Glargine or Insulin Degludec, in Adults With Type 1 Diabetes PRONTO-T1D', 'orgStudyIdInfo': {'id': '16313'}, 'secondaryIdInfos': [{'id': 'I8B-MC-ITRM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2015-005356-99', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY900014', 'description': 'LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'interventionNames': ['Drug: LY900014', 'Drug: Insulin Glargine', 'Drug: Insulin Degludec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Lispro (Humalog)', 'description': 'Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'interventionNames': ['Drug: Insulin Lispro', 'Drug: Insulin Glargine', 'Drug: Insulin Degludec']}, {'type': 'EXPERIMENTAL', 'label': 'LY900014 Postmeal (Open Label)', 'description': 'LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.', 'interventionNames': ['Drug: LY900014', 'Drug: Insulin Glargine', 'Drug: Insulin Degludec']}, {'type': 'EXPERIMENTAL', 'label': 'LY900014 - Maximum Extended Enrollment (MEE)', 'description': 'LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'interventionNames': ['Drug: LY900014', 'Drug: Insulin Glargine', 'Drug: Insulin Degludec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Lispro (Humalog)-MEE', 'description': 'Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.', 'interventionNames': ['Drug: Insulin Lispro', 'Drug: Insulin Glargine', 'Drug: Insulin Degludec']}, {'type': 'EXPERIMENTAL', 'label': 'LY900014 Postmeal (Open Label)-MEE', 'description': 'LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.', 'interventionNames': ['Drug: LY900014', 'Drug: Insulin Glargine', 'Drug: Insulin Degludec']}], 'interventions': [{'name': 'LY900014', 'type': 'DRUG', 'otherNames': ['Ultra-Rapid Lispro'], 'description': 'Administered SC', 'armGroupLabels': ['LY900014', 'LY900014 - Maximum Extended Enrollment (MEE)', 'LY900014 Postmeal (Open Label)', 'LY900014 Postmeal (Open Label)-MEE']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'otherNames': ['Humalog'], 'description': 'Administered SC', 'armGroupLabels': ['Insulin Lispro (Humalog)', 'Insulin Lispro (Humalog)-MEE']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Insulin Lispro (Humalog)', 'Insulin Lispro (Humalog)-MEE', 'LY900014', 'LY900014 - Maximum Extended Enrollment (MEE)', 'LY900014 Postmeal (Open Label)', 'LY900014 Postmeal (Open Label)-MEE']}, {'name': 'Insulin Degludec', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Insulin Lispro (Humalog)', 'Insulin Lispro (Humalog)-MEE', 'LY900014', 'LY900014 - Maximum Extended Enrollment (MEE)', 'LY900014 Postmeal (Open Label)', 'LY900014 Postmeal (Open Label)-MEE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Internal Medicine Center LLC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Physician Network Clinical Research Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute INC', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Endocrine, Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Marin Endocrine Associates', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes and Endocrine Associates', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'University Clinical Investigators, Inc.', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Coastal Metabolic Research Centre', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Childhood Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33312', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center For Diabetes & Endocrine Care', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'East Coast Institute For Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Sun Coast Clinical Research, Inc', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Metabolic Research Institute Inc.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'East Coast Institute For Research', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endocrine Research Solutions, Inc.', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East West Medical Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Northwest Clinical Trials', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Diabetes and Osteoporosis Center', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '62711', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Education and Research Cooperative', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iderc, P.L.C.', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': "Cotton O'Neil Diabetes and Endocrinology Center", 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Diabetes Endocrinology Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02453', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MassResearch', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Research Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Research Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03063', 'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Southern New Hampshire Diabetes and Endocrinology', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Medical Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27843', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Physicians East', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Diabetes & Endocrinology Consultants PC', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington, LLC', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Your Diabetes Endocrine Nutrition Group PC', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Partners in Nephrology & Endocrinology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Sudir Bansal M.D. Inc.', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '37411', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University Diabetes and Endocrine Consultants', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78731-4309', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes and Endocrinology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Diabetes Endocrine Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes and Endocrinology, P.A.', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Consano Clinical Research', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 40.88939, 'lon': -111.88077}}, {'zip': '98003', 'city': 'Federal Way', 'state': 'Washington', 'country': 'United States', 'facility': 'Private: Dr. Larry Stonesifer', 'geoPoint': {'lat': 47.32232, 'lon': -122.31262}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': 'C1013AAB', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1056ABJ', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1179AAB', 'city': 'Caba', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.'}, {'zip': 'C1180AAX', 'city': 'Caba', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.'}, {'zip': '1408', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information 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- 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '64710', 'city': 'Monterrey', 'country': 'Mexico', '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': 25.68435, 'lon': -100.31721}}, {'zip': '45116', 'city': 'Zapopan', 'country': 'Mexico', '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': 20.72111, 'lon': -103.38742}}, {'zip': '0620', 'city': 'Takapuna', 'state': 'Auckland', 'country': 'New Zealand', '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': -36.79167, 'lon': 174.77583}}, {'zip': '2025', 'city': 'Auckland', 'country': 'New Zealand', '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': -36.84853, 'lon': 174.76349}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', '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': -43.53333, 'lon': 172.63333}}, {'zip': '6021', 'city': 'Wellington', 'country': 'New Zealand', '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': -41.28664, 'lon': 174.77557}}, {'zip': '80-546', 'city': 'Gdansk', 'country': 'Poland', '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': 54.35227, 'lon': 18.64912}}, {'zip': '31-500', 'city': 'Krakow', 'country': 'Poland', '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': 50.06143, 'lon': 19.93658}}, {'zip': '90-132', 'city': 'Lodz', 'country': 'Poland', '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': 51.77058, 'lon': 19.47395}}, {'zip': '20-333', 'city': 'Lublin', 'country': 'Poland', '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': 51.25058, 'lon': 22.57009}}, {'zip': '20-538', 'city': 'Lublin', 'country': 'Poland', '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': 51.25058, 'lon': 22.57009}}, {'zip': '41-709', 'city': 'Ruda Śląska', 'country': 'Poland', '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': 50.2584, 'lon': 18.85632}}, {'zip': '70-376', 'city': 'Szczecin', 'country': 'Poland', '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': 53.42894, 'lon': 14.55302}}, {'zip': '70-506', 'city': 'Szczecin', 'country': 'Poland', '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': 53.42894, 'lon': 14.55302}}, {'zip': '01-518', 'city': 'Warsaw', 'country': 'Poland', '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': 52.22977, 'lon': 21.01178}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', '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': 52.22977, 'lon': 21.01178}}, {'zip': '50-403', 'city': 'Wroclaw', 'country': 'Poland', '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': 51.10286, 'lon': 17.03006}}, {'zip': '00956', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Dr Altagracia Aurora Alcantara Gonzalez', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '00961', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Advanced Clinical Research, LLC', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '00674', 'city': 'Manatí', 'country': 'Puerto Rico', 'facility': 'Manati Center for Clinical Research Inc', 'geoPoint': {'lat': 18.42745, 'lon': -66.49212}}, {'zip': '00921', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Martha Gomez Cuellar M.D.', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00767', 'city': 'Yabucoa', 'country': 'Puerto Rico', 'facility': 'Centro de Endocrinologia del Este', 'geoPoint': {'lat': 18.05052, 'lon': -65.87933}}, {'zip': '600164', 'city': 'Bacau', 'country': 'Romania', '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': 46.56718, 'lon': 26.91384}}, {'zip': '500283', 'city': 'Brasov', 'country': 'Romania', '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': 45.64861, 'lon': 25.60613}}, {'zip': '013682', 'city': 'Bucharest', 'country': 'Romania', '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': 44.43225, 'lon': 26.10626}}, {'zip': '700547', 'city': 'Lasi', 'country': 'Romania', '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.'}, {'zip': '410025', 'city': 'Oradea', 'country': 'Romania', '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': 47.0458, 'lon': 21.91833}}, {'zip': '100163', 'city': 'Ploieşti', 'country': 'Romania', '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': 44.95, 'lon': 26.01667}}, {'zip': '100342', 'city': 'Ploieşti', 'country': 'Romania', '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': 44.95, 'lon': 26.01667}}, {'zip': '440055', 'city': 'Satu Mare', 'country': 'Romania', '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': 47.79926, 'lon': 22.86255}}, {'zip': '540098', 'city': 'Târgu Mureş', 'country': 'Romania', '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': 46.54245, 'lon': 24.55747}}, {'zip': '300456', 'city': 'Timișoara', 'country': 'Romania', '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': 45.75372, 'lon': 21.22571}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', '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': 64.5461, 'lon': 40.55183}}, {'zip': '305014', 'city': 'Kursk', 'country': 'Russia', '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': 51.72689, 'lon': 36.18457}}, {'zip': '117036', 'city': 'Moscow', 'country': 'Russia', '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': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', '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': 55.75204, 'lon': 37.61781}}, {'zip': '123182', 'city': 'Moscow', 'country': 'Russia', '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': 55.75204, 'lon': 37.61781}}, {'zip': '195257', 'city': 'Saint Petersburg', 'country': 'Russia', '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': 59.93863, 'lon': 30.31413}}, {'zip': '410053', 'city': 'Saratov', 'country': 'Russia', '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': 51.54048, 'lon': 45.9901}}, {'zip': '04012', 'city': 'Košice', 'country': 'Slovakia', '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': 48.71441, 'lon': 21.25802}}, {'zip': '90101', 'city': 'Malacky', 'country': 'Slovakia', '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': 48.43604, 'lon': 17.02188}}, {'zip': '91501', 'city': 'Nové Mesto nad Váhom', 'country': 'Slovakia', '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': 48.75763, 'lon': 17.8309}}, {'zip': '048 01', 'city': 'Rožňava', 'country': 'Slovakia', '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': 48.66009, 'lon': 20.53758}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', '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': 41.54329, 'lon': 2.10942}}, {'zip': '46600', 'city': 'Alzira', 'state': 'Valencia', 'country': 'Spain', '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': 39.15, 'lon': -0.43333}}, {'zip': '29006', 'city': 'Málaga', 'country': 'Spain', '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': 36.72016, 'lon': -4.42034}}, {'zip': '41003', 'city': 'Seville', 'country': 'Spain', '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': 37.38283, 'lon': -5.97317}}, {'zip': '41010', 'city': 'Seville', 'country': 'Spain', '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': 37.38283, 'lon': -5.97317}}, {'zip': '41071', 'city': 'Seville', 'country': 'Spain', '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': 37.38283, 'lon': -5.97317}}, {'zip': '44002', 'city': 'Teruel', 'country': 'Spain', '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': 40.3456, 'lon': -1.10646}}, {'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', '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': 57.70716, 'lon': 11.96679}}, {'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', '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': 58.41086, 'lon': 15.62157}}, {'zip': '22185', 'city': 'Lund', 'country': 'Sweden', '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': 55.70584, 'lon': 13.19321}}, {'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', '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': 59.32938, 'lon': 18.06871}}, {'zip': '500', 'city': 'Chang-hua', 'country': 'Taiwan', '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': 24.07327, 'lon': 120.56276}}, {'zip': '40201', 'city': 'Taichung', 'country': 'Taiwan', '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': 24.1469, 'lon': 120.6839}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', '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': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', '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': 22.99083, 'lon': 120.21333}}, {'zip': '10507', 'city': 'Taipei', 'country': 'Taiwan', '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': 25.05306, 'lon': 121.52639}}, {'zip': '71004', 'city': 'Yongkang District', 'country': 'Taiwan', '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': 23.02444, 'lon': 120.25556}}], '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'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}