Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 11:42 PM
Study NCT ID:
NCT01774968
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2013-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Serious Adverse Events and Other Adverse Events Tables include all randomized participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.', 'otherNumAtRisk': 162, 'otherNumAffected': 80, 'seriousNumAtRisk': 162, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.', 'otherNumAtRisk': 163, 'otherNumAffected': 94, 'seriousNumAtRisk': 163, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mesenteric vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Endometrial cancer stage i', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Viith nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.12', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3709', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.12', 'groupDescription': 'Approximately 325 participants were to be randomized (in a 1:1 ratio of U-500R insulin TID:BID) and 260 were to complete the study (with a 20% dropout rate). The 260 completers would provide a 66.4% chance to show equivalence of TID and BID algorithms, 14.4% chance to show noninferiority of TID, 2.5% chance to superiority of TID, 14.4% chance to show noninferiority of BID, and 2.5% chance to show superiority of BID, assuming a difference in HbA1c change of 0% and a standard deviation of 1.1%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A non-inferiority margin of 0.4% was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'HbA1c ≤6.5% (n=159, 161)', 'categories': [{'measurements': [{'value': '20.13', 'groupId': 'OG000'}, {'value': '23.60', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.0% (n=158, 159)', 'categories': [{'measurements': [{'value': '42.41', 'groupId': 'OG000'}, {'value': '41.51', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.5% (n=148, 143)', 'categories': [{'measurements': [{'value': '64.19', 'groupId': 'OG000'}, {'value': '61.54', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <8.0% (n=120, 123)', 'categories': [{'measurements': [{'value': '77.50', 'groupId': 'OG000'}, {'value': '77.24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The percentage of participants achieving an HbA1c of ≤6.5%, \\<7.0%, \\<7.5%, and \\<8.0% at Week 24 was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data.'}, {'type': 'SECONDARY', 'title': '30-Day Adjusted Rate of Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'Severe HE', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.053', 'groupId': 'OG001'}]}]}, {'title': 'Documented Symptomatic HE', 'categories': [{'measurements': [{'value': '3.343', 'spread': '3.174', 'groupId': 'OG000'}, {'value': '3.885', 'spread': '3.448', 'groupId': 'OG001'}]}]}, {'title': 'Documented Symptomatic Nocturnal HE', 'categories': [{'measurements': [{'value': '1.013', 'spread': '1.438', 'groupId': 'OG000'}, {'value': '1.299', 'spread': '1.540', 'groupId': 'OG001'}]}]}, {'title': 'Asymptomatic HE', 'categories': [{'measurements': [{'value': '1.340', 'spread': '3.215', 'groupId': 'OG000'}, {'value': '1.028', 'spread': '2.231', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 24', 'description': 'Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person \\[accompanied by neurologic/cognitive impairment\\]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose \\[PG\\] ≤70 milligrams per deciliter \\[mg/dL\\]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'events per participant per 30 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.44', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '4.88', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.19', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '51.39', 'spread': '10.24', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.', 'unitOfMeasure': 'units per kilogram (units/kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.66', 'spread': '5.64', 'groupId': 'OG000'}, {'value': '-8.86', 'spread': '5.72', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline FPG as a covariate.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R with evaluable FPG data.'}, {'type': 'SECONDARY', 'title': 'Time to Reach HbA1c Target Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'HbA1c ≤6.5%, Week 6 (n=154, 155)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c ≤6.5%, Week 12 (n=145, 151)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c ≤6.5%, Week 18 (n=140, 145)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c ≤6.5%, Week 24 (n=76, 65)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.0%, Week 6 (n=154, 153)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.0%, Week 12 (n=148, 149)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.0%, Week 18 (n=144, 145)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.0%, Week 24 (n=53, 52)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.5%, Week 6 (n=144, 137)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.5%, Week 12 (n=140, 134)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.5%, Week 18 (n=136, 132)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.5%, Week 24 (n=34, 31)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <8.0%, Week 6 (n=117, 117)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <8.0%, Week 12 (n=114, 115)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <8.0%, Week 18 (n=111, 113)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <8.0%, Week 24 (n=20, 19)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 6, 12, 18, and 24 weeks.', 'description': 'The cumulative number of participants achieving an HbA1c of ≤6.5%, \\<7.0%, \\<7.5%, and \\<8.0% is summarized at Weeks 6, 12, 18, and 24. The number of participants at risk (n) is also provided for each target value and timepoint.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'Severe HE', 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000'}, {'value': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'Documented Symptomatic HE', 'categories': [{'measurements': [{'value': '91.98', 'groupId': 'OG000'}, {'value': '90.06', 'groupId': 'OG001'}]}]}, {'title': 'Documented Symptomatic Nocturnal HE', 'categories': [{'measurements': [{'value': '77.78', 'groupId': 'OG000'}, {'value': '80.75', 'groupId': 'OG001'}]}]}, {'title': 'Asymptomatic HE', 'categories': [{'measurements': [{'value': '64.20', 'groupId': 'OG000'}, {'value': '66.46', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 24', 'description': 'Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person \\[accompanied by neurologic/cognitive impairment\\]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose \\[PG\\] ≤70 milligrams per deciliter \\[mg/dL\\]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The percentage of participants with HE at 24 weeks was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in Number of Insulin Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.765', 'spread': '1.234', 'groupId': 'OG000'}, {'value': '4.783', 'spread': '1.307', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '3.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '2.000', 'spread': '0.000', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.', 'unitOfMeasure': 'injections per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R. Last observation carried forward (LOCF) was used to impute missing postbaseline values.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'Pre-morning Meal (n=150, 149)', 'categories': [{'measurements': [{'value': '-24.10', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '-29.19', 'spread': '3.91', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Morning Meal (n=146, 133)', 'categories': [{'measurements': [{'value': '-21.68', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '-31.32', 'spread': '4.29', 'groupId': 'OG001'}]}]}, {'title': 'Pre-midday Meal (n=150, 149)', 'categories': [{'measurements': [{'value': '-23.54', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '-32.26', 'spread': '4.11', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Midday Meal (n=143, 133)', 'categories': [{'measurements': [{'value': '-24.31', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '-22.53', 'spread': '4.49', 'groupId': 'OG001'}]}]}, {'title': 'Pre-evening Meal (n=150, 149)', 'categories': [{'measurements': [{'value': '-34.17', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '-32.96', 'spread': '3.85', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Evening Meal (n=147, 142)', 'categories': [{'measurements': [{'value': '-40.56', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '-38.36', 'spread': '4.11', 'groupId': 'OG001'}]}]}, {'title': '3 AM (n=147, 140)', 'categories': [{'measurements': [{'value': '-36.77', 'spread': '4.34', 'groupId': 'OG000'}, {'value': '-47.82', 'spread': '4.29', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The 7-point SMBG is a participant self-administered blood glucose test which utilizes measurements at specific time points over a 24-hour period, including pre-morning meal (fasting), 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and 3 AM. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline SMBG as a covariate.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R with evaluable SMBG data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'Baseline TDD ≤2.0 units/kg (n=50, 46)', 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TDD >2.0 units/kg (n=112, 115)', 'categories': [{'measurements': [{'value': '-1.19', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or \\>2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'Severe HE, TDD ≤2 units/kg, Baseline (n=50, 46)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe HE, TDD ≤2 units/kg, Week 24 (n=50, 46)', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe HE, TDD >2 units/kg, Baseline (n=112, 115)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe HE, TDD >2 units/kg, Week 24 (n=112, 115)', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'DS HE, TDD ≤2 units/kg, Baseline (n=50, 46)', 'categories': [{'measurements': [{'value': '1.958', 'spread': '4.808', 'groupId': 'OG000'}, {'value': '1.454', 'spread': '3.251', 'groupId': 'OG001'}]}]}, {'title': 'DS HE, TDD ≤2 units/kg, Week 24 (n=50, 46))', 'categories': [{'measurements': [{'value': '2.356', 'spread': '2.352', 'groupId': 'OG000'}, {'value': '3.131', 'spread': '3.204', 'groupId': 'OG001'}]}]}, {'title': 'DS HE, TDD >2 units/kg, Baseline (n=112, 115)', 'categories': [{'measurements': [{'value': '2.037', 'spread': '4.382', 'groupId': 'OG000'}, {'value': '1.730', 'spread': '3.180', 'groupId': 'OG001'}]}]}, {'title': 'DS HE, TDD >2 units/kg, Week 24 (n=112, 115)', 'categories': [{'measurements': [{'value': '3.784', 'spread': '3.397', 'groupId': 'OG000'}, {'value': '4.186', 'spread': '3.509', 'groupId': 'OG001'}]}]}, {'title': 'Noc. HE, TDD ≤2 units/kg, Baseline (n=50, 46)', 'categories': [{'measurements': [{'value': '1.066', 'spread': '2.045', 'groupId': 'OG000'}, {'value': '0.711', 'spread': '1.965', 'groupId': 'OG001'}]}]}, {'title': 'Noc. HE, TDD ≤2 units/kg, Week 24 (n=50, 46)', 'categories': [{'measurements': [{'value': '1.105', 'spread': '1.153', 'groupId': 'OG000'}, {'value': '1.282', 'spread': '1.431', 'groupId': 'OG001'}]}]}, {'title': 'Noc. HE, TDD >2 units/kg, Baseline (n=112, 115)', 'categories': [{'measurements': [{'value': '0.792', 'spread': '2.465', 'groupId': 'OG000'}, {'value': '0.585', 'spread': '1.445', 'groupId': 'OG001'}]}]}, {'title': 'Noc. HE, TDD >2 units/kg, Week 24 (n=112, 115)', 'categories': [{'measurements': [{'value': '1.522', 'spread': '2.018', 'groupId': 'OG000'}, {'value': '1.753', 'spread': '1.934', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or \\>2.0 units/kg). Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person \\[accompanied by neurologic/cognitive impairment\\]), documented symptomatic (DS; an event which is associated with signs/symptoms of hypoglycemia and plasma glucose \\[PG\\] ≤70 milligrams per deciliter \\[mg/dL\\]), or nocturnal (Noc; any documented symptomatic HE that occurred between bedtime and waking). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'events per participant per 30 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'Baseline TDD≤2.0 U/kg, Baseline risk (n=50, 46)', 'categories': [{'measurements': [{'value': '56.00', 'groupId': 'OG000'}, {'value': '39.13', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TDD ≤2.0 U/kg, Week 24 risk (n=50, 46)', 'categories': [{'measurements': [{'value': '94.00', 'groupId': 'OG000'}, {'value': '86.96', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TDD >2.0 U/kg, Baseline risk (n=112, 115)', 'categories': [{'measurements': [{'value': '47.32', 'groupId': 'OG000'}, {'value': '51.30', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TDD >2.0 U/kg, Week 24 risk (n=112, 115)', 'categories': [{'measurements': [{'value': '96.43', 'groupId': 'OG000'}, {'value': '97.39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were stratified by their baseline TDD insulin (≤2.0 units (U)/kg or \\>2.0 U/kg). The percentage of participants at risk of developing hypoglycemia (including documented symptomatic, asymptomatic, probable symptomatic, unspecified, or severe hypoglycemia) is presented at Baseline and at Week 24 and was calculated using MMRM fit with options of the binomial distribution and log link function including treatment, TDD (\\>300 units or ≤300 units), pioglitazone use (yes or no), visit, and treatment-by-visit interaction as fixed effects, and baseline HbA1c value as a covariate.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'OG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}], 'classes': [{'title': 'Baseline TDD insulin ≤2.0 units/kg (n=50, 46)', 'categories': [{'measurements': [{'value': '6.11', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '6.09', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TDD insulin >2.0 units/kg (n=112, 115)', 'categories': [{'measurements': [{'value': '5.08', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or \\>2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.'}, {'id': 'FG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Human Regular U-500 Insulin TID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.'}, {'id': 'BG001', 'title': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.31', 'spread': '10.51', 'groupId': 'BG000'}, {'value': '55.50', 'spread': '9.03', 'groupId': 'BG001'}, {'value': '55.41', 'spread': '9.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2013-01-22', 'resultsFirstSubmitDate': '2015-04-24', 'studyFirstSubmitQcDate': '2013-01-22', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-24', 'studyFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 24', 'description': 'Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24', 'timeFrame': 'Week 24', 'description': 'The percentage of participants achieving an HbA1c of ≤6.5%, \\<7.0%, \\<7.5%, and \\<8.0% at Week 24 was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100.'}, {'measure': '30-Day Adjusted Rate of Hypoglycemic Events', 'timeFrame': 'Baseline through Week 24', 'description': 'Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person \\[accompanied by neurologic/cognitive impairment\\]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose \\[PG\\] ≤70 milligrams per deciliter \\[mg/dL\\]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Change From Baseline to Week 24 in Body Weight', 'timeFrame': 'Baseline, Week 24', 'description': 'LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.'}, {'measure': 'Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin', 'timeFrame': 'Baseline, Week 24', 'description': 'Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.'}, {'measure': 'Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin', 'timeFrame': 'Baseline, Week 24', 'description': 'Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.'}, {'measure': 'Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels', 'timeFrame': 'Baseline, Week 24', 'description': 'LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline FPG as a covariate.'}, {'measure': 'Time to Reach HbA1c Target Values', 'timeFrame': 'Baseline through 6, 12, 18, and 24 weeks.', 'description': 'The cumulative number of participants achieving an HbA1c of ≤6.5%, \\<7.0%, \\<7.5%, and \\<8.0% is summarized at Weeks 6, 12, 18, and 24. The number of participants at risk (n) is also provided for each target value and timepoint.'}, {'measure': 'Percentage of Participants With Hypoglycemic Events', 'timeFrame': 'Baseline through Week 24', 'description': 'Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person \\[accompanied by neurologic/cognitive impairment\\]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose \\[PG\\] ≤70 milligrams per deciliter \\[mg/dL\\]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The percentage of participants with HE at 24 weeks was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Change From Baseline to Week 24 in Number of Insulin Injections', 'timeFrame': 'Baseline, Week 24', 'description': 'The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.'}, {'measure': 'Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)', 'timeFrame': 'Baseline, Week 24', 'description': 'The 7-point SMBG is a participant self-administered blood glucose test which utilizes measurements at specific time points over a 24-hour period, including pre-morning meal (fasting), 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and 3 AM. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline SMBG as a covariate.'}, {'measure': 'Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or \\>2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.'}, {'measure': 'Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or \\>2.0 units/kg). Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person \\[accompanied by neurologic/cognitive impairment\\]), documented symptomatic (DS; an event which is associated with signs/symptoms of hypoglycemia and plasma glucose \\[PG\\] ≤70 milligrams per deciliter \\[mg/dL\\]), or nocturnal (Noc; any documented symptomatic HE that occurred between bedtime and waking). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were stratified by their baseline TDD insulin (≤2.0 units (U)/kg or \\>2.0 U/kg). The percentage of participants at risk of developing hypoglycemia (including documented symptomatic, asymptomatic, probable symptomatic, unspecified, or severe hypoglycemia) is presented at Baseline and at Week 24 and was calculated using MMRM fit with options of the binomial distribution and log link function including treatment, TDD (\\>300 units or ≤300 units), pioglitazone use (yes or no), visit, and treatment-by-visit interaction as fixed effects, and baseline HbA1c value as a covariate.'}, {'measure': 'Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or \\>2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or \\>8%), baseline TDD (≤300 or \\>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '27716283', 'type': 'DERIVED', 'citation': 'Kabul S, Hood RC, Duan R, DeLozier AM, Settles J. Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial. Health Qual Life Outcomes. 2016 Sep 30;14(1):139. doi: 10.1186/s12955-016-0541-4.'}, {'pmid': '26307903', 'type': 'DERIVED', 'citation': 'Mari A, Rosenstock J, Ma X, Li YG, Jackson JA. OPTIMIZED HUMAN REGULAR U-500 INSULIN TREATMENT IMPROVES beta-CELL FUNCTION IN SEVERELY INSULIN-RESISTANT PATIENTS WITH LONG-STANDING TYPE 2 DIABETES AND HIGH INSULIN REQUIREMENTS. Endocr Pract. 2015 Dec;21(12):1344-52. doi: 10.4158/EP15898.OR. Epub 2015 Aug 26.'}, {'pmid': '25813411', 'type': 'DERIVED', 'citation': 'Hood RC, Arakaki RF, Wysham C, Li YG, Settles JA, Jackson JA. TWO TREATMENT APPROACHES FOR HUMAN REGULAR U-500 INSULIN IN PATIENTS WITH TYPE 2 DIABETES NOT ACHIEVING ADEQUATE GLYCEMIC CONTROL ON HIGH-DOSE U-100 INSULIN THERAPY WITH OR WITHOUT ORAL AGENTS: A RANDOMIZED, TITRATION-TO-TARGET CLINICAL TRIAL. Endocr Pract. 2015 Jul;21(7):782-93. doi: 10.4158/EP15612.OR. Epub 2015 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Major Inclusion Criteria:\n\n* Have type 2 diabetes mellitus (World Health Organization \\[WHO\\] Classification of Diabetes)\n* Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m\\^2)\n* Have Glycated Hemoglobin A1c (HbA1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry\n* Current U-100 insulin/analogue users on \\>200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization\n* Have a history of stable body weight for at least 3 months prior to study entry\n* Concomitant medications may include metformin (MET), dipeptidyl peptidase-4 (DPP-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (SUs)/glinides (repaglinide or nateglinide). Participant's oral antihyperglycemic drug (OAD) dose(s) must have been stable for ≥3 months\n\nMajor Exclusion Criteria:\n\n* Have type 1 diabetes mellitus or other types of diabetes mellitus apart from type 2 diabetes mellitus\n* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range\n* Have chronic kidney disease stage 4 and higher or history of renal transplantation\n* Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to study entry\n* Have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry\n* Have received U-500R in the 3 months prior to study entry\n* Have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia\n* Are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry\n* Have an irregular sleep/wake cycle\n* Have used rosiglitazone, once- or twice-daily glucagon-like peptide-1 (GLP-1) receptor agents, pramlintide, or other injectable or oral antihyperglycemic therapy not listed in the inclusion criteria in the 3 months prior to study entry. Participants may not have used once-weekly GLP-1 receptor agents in the 4 months prior to study entry\n* Have used any weight loss drugs in the 3 months prior to study entry\n* Have a history of bariatric surgery\n* Have a history of malignancy other than basal cell or squamous cell skin cancer\n* Have New York Heart Association (NYHA) Class III or IV per NYHA Cardiac Disease Functional Classification\n* Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable"}, 'identificationModule': {'nctId': 'NCT01774968', 'briefTitle': 'Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Two Treatment Approaches for Human Regular U-500 Insulin (Thrice-Daily Versus Twice-Daily) in Subjects With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial', 'orgStudyIdInfo': {'id': '14838'}, 'secondaryIdInfos': [{'id': 'B5K-US-IBHC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Human Regular U-500 Insulin TID', 'description': 'Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.', 'interventionNames': ['Drug: Human Regular U-500 Insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Human Regular U-500 Insulin BID', 'description': 'U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.', 'interventionNames': ['Drug: Human Regular U-500 Insulin']}], 'interventions': [{'name': 'Human Regular U-500 Insulin', 'type': 'DRUG', 'otherNames': ['LY041001', 'Humulin R', 'U-500R'], 'armGroupLabels': ['Human Regular U-500 Insulin BID', 'Human Regular U-500 Insulin TID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33619', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60012', 'city': 'Crystal Lake', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.24113, 'lon': -88.3162}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03063', 'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37411', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77701', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98003', 'city': 'Federal Way', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.32232, 'lon': -122.31262}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '00956', 'city': 'Bayamón', 'country': 'Puerto Rico', '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': 18.39856, 'lon': -66.15572}}, {'zip': '00921', 'city': 'Las Lomas', 'country': 'Puerto Rico', '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': 18.06191, 'lon': -66.50989}}, {'zip': '00674', 'city': 'Manatí', 'country': 'Puerto Rico', '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': 18.42745, 'lon': -66.49212}}, {'zip': '00917-3104', 'city': 'San Juan', 'country': 'Puerto Rico', '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': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}