Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-18 @ 12:13 PM
Study NCT ID:
NCT01582451
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2012-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587357', 'term': 'LY2605541'}, {'id': 'C000621851', 'term': 'basal insulin peglispro'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': 'Includes events from participants who were randomized and had at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.', 'otherNumAtRisk': 305, 'otherNumAffected': 223, 'seriousNumAtRisk': 305, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.', 'otherNumAtRisk': 159, 'otherNumAffected': 104, 'seriousNumAtRisk': 159, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 63, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 27, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac vein perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Postoperative respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rectosigmoid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urethral obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': "HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol \\[LDL-C, \\<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\\], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.", 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 52 Weeks in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': 'Total hypoglycemia, 0-26 weeks', 'categories': [{'measurements': [{'value': '1.55', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Total hypoglycemia, 0-52 weeks', 'categories': [{'measurements': [{'value': '1.24', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal hypoglycemia, 0-26 weeks', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal hypoglycemia, 0-52 weeks', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 26 weeks and Baseline through 52 weeks', 'description': 'Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter \\[mmol/L\\]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, with log \\[exposure in days/30\\] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.', 'unitOfMeasure': 'events/participant/30 days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': 'Total hypoglycemia, 0-26 weeks', 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000'}, {'value': '80.5', 'groupId': 'OG001'}]}]}, {'title': 'Total hypoglycemia, 0-52 weeks', 'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000'}, {'value': '83.0', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal hypoglycemia, 0-26 weeks', 'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000'}, {'value': '62.3', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal hypoglycemia, 0-52 weeks', 'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000'}, {'value': '67.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 26 weeks and Baseline through 52 weeks', 'description': 'Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': 'HbA1c ≤6.5%, 26 weeks', 'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000'}, {'value': '28.7', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c ≤6.5%, 52 weeks', 'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.0%, 26 weeks', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}, {'value': '52.2', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.0%, 52 weeks', 'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000'}, {'value': '45.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 and 52 weeks', 'description': 'The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with by applying the last observation carried forward (LOCF) method to the post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 and 52 weeks', 'description': 'Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with HbA1c \\<7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with by applying the LOCF method to the post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Fasting Serum Glucose (FSG) (by Laboratory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '103.80', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '119.50', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '107.61', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '115.74', 'spread': '2.72', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 and 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \\[≤8.0% and \\>8.0%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Fasting Blood Glucose (FBG) (by Self Monitoring)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '106.32', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '104.50', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '110.61', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '107.46', 'spread': '1.68', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 and 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \\[≤8.0% and \\>8.0%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Intra-participant Variability in Fasting Blood Glucose (FBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '13.70', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '17.90', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '14.18', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '17.38', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 and 52 weeks', 'description': 'FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': '6-point Self-monitored Blood Glucose (SMBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': 'Pre-morning meal, 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '107.93', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '104.11', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'Pre-midday meal, 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120.87', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '132.56', 'spread': '3.11', 'groupId': 'OG001'}]}]}, {'title': 'Pre-evening meal, 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125.87', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '141.45', 'spread': '3.08', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime, 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '146.54', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '161.48', 'spread': '3.69', 'groupId': 'OG001'}]}]}, {'title': '0300 hours, 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.43', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '120.42', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'Pre-morning meal next day, 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106.28', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '102.79', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Pre-morning meal, 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.84', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '108.22', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Pre-midday meal, 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121.34', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '130.55', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Pre-evening meal, 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.53', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '141.31', 'spread': '2.82', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime, 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '146.92', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '161.83', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': '0300 hours, 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.23', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '121.07', 'spread': '2.76', 'groupId': 'OG001'}]}]}, {'title': 'Pre-morning meal next day, 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.38', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '106.68', 'spread': '1.97', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 and 52 weeks', 'description': 'SMBG measurements were taken at 6 time points (pre-morning meal \\[fasting\\], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal \\[fasting\\] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c \\[≤8.5% and \\>8.5%\\], country, LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '6.60', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '7.13', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '6.75', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 and 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose Per Kilogram of Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 and 52 weeks', 'description': 'Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose.', 'unitOfMeasure': 'units per kilogram per day (U/kg/day)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.'}, {'type': 'SECONDARY', 'title': 'Number of Insulin Dose Adjustments to Steady-state', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.06', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 26 weeks', 'description': 'The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use).', 'unitOfMeasure': 'number of dose adjustments', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'European Quality of Life - 5 Dimension (EuroQol-5D) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'The EuroQol-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], and SU or meglitinide use), and baseline EuroQol-5D score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable EuroQol-5D data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Insulin Treatment Satisfaction Questionnaire (ITSQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.69', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '84.43', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Adult Low Blood Sugar Survey (LBSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.57', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '15.63', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'LBSS (also referenced as Hypoglycemia Fear Survey - II \\[HFS-II\\]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], LDL-C \\[\\<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipid Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'title': 'Cholesterol, 26 weeks', 'categories': [{'measurements': [{'value': '2.24', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol, 52 weeks', 'categories': [{'measurements': [{'value': '-1.35', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'HDL-C, 26 weeks', 'categories': [{'measurements': [{'value': '-1.74', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'HDL-C, 52 weeks', 'categories': [{'measurements': [{'value': '-3.52', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-2.01', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'LDL-C, 26 weeks', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '4.54', 'spread': '2.00', 'groupId': 'OG001'}]}]}, {'title': 'LDL-C, 52 weeks', 'categories': [{'measurements': [{'value': '-3.38', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, 26 weeks', 'categories': [{'measurements': [{'value': '22.53', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '-2.90', 'spread': '5.23', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, 52 week', 'categories': [{'measurements': [{'value': '27.39', 'spread': '4.00', 'groupId': 'OG000'}, {'value': '12.02', 'spread': '5.59', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, 52 weeks', 'description': 'Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], LDL-C \\[\\<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Anti-LY2605541 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 weeks', 'description': 'The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by subcutaneous (SQ) injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG).'}, {'id': 'FG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '305'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LY2605541', 'description': 'LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'BG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.84', 'spread': '8.52', 'groupId': 'BG000'}, {'value': '60.38', 'spread': '10.10', 'groupId': 'BG001'}, {'value': '61.34', 'spread': '9.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 466}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2014-04-14', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-17', 'studyFirstSubmitDate': '2012-04-19', 'dispFirstSubmitQcDate': '2014-04-14', 'resultsFirstSubmitDate': '2018-03-17', 'studyFirstSubmitQcDate': '2012-04-19', 'dispFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-17', 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, 26 weeks', 'description': "HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol \\[LDL-C, \\<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\\], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to 52 Weeks in HbA1c', 'timeFrame': 'Baseline, 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.'}, {'measure': 'Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)', 'timeFrame': 'Baseline through 26 weeks and Baseline through 52 weeks', 'description': 'Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter \\[mmol/L\\]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, with log \\[exposure in days/30\\] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.'}, {'measure': 'Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events', 'timeFrame': 'Baseline through 26 weeks and Baseline through 52 weeks', 'description': 'Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.'}, {'measure': 'Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%', 'timeFrame': '26 and 52 weeks', 'description': 'The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.'}, {'measure': 'Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia', 'timeFrame': '26 and 52 weeks', 'description': 'Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with HbA1c \\<7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.'}, {'measure': 'Fasting Serum Glucose (FSG) (by Laboratory)', 'timeFrame': '26 and 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \\[≤8.0% and \\>8.0%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG.'}, {'measure': 'Fasting Blood Glucose (FBG) (by Self Monitoring)', 'timeFrame': '26 and 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \\[≤8.0% and \\>8.0%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG.'}, {'measure': 'Intra-participant Variability in Fasting Blood Glucose (FBG)', 'timeFrame': '26 and 52 weeks', 'description': 'FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability.'}, {'measure': '6-point Self-monitored Blood Glucose (SMBG)', 'timeFrame': '26 and 52 weeks', 'description': 'SMBG measurements were taken at 6 time points (pre-morning meal \\[fasting\\], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal \\[fasting\\] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c \\[≤8.5% and \\>8.5%\\], country, LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values.'}, {'measure': 'HbA1c', 'timeFrame': '26 and 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.'}, {'measure': 'Insulin Dose Per Kilogram of Body Weight', 'timeFrame': '26 and 52 weeks', 'description': 'Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose.'}, {'measure': 'Number of Insulin Dose Adjustments to Steady-state', 'timeFrame': 'Baseline through 26 weeks', 'description': 'The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], baseline LDL-C \\[\\<100 mg/dL and ≥100 mg/dL\\], and SU or meglitinide use).'}, {'measure': 'European Quality of Life - 5 Dimension (EuroQol-5D) Score', 'timeFrame': '26 weeks', 'description': 'The EuroQol-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], and SU or meglitinide use), and baseline EuroQol-5D score.'}, {'measure': 'Insulin Treatment Satisfaction Questionnaire (ITSQ) Score', 'timeFrame': '26 weeks', 'description': 'ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate.'}, {'measure': 'Adult Low Blood Sugar Survey (LBSS) Score', 'timeFrame': '26 weeks', 'description': 'LBSS (also referenced as Hypoglycemia Fear Survey - II \\[HFS-II\\]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline, 26 weeks, 52 weeks', 'description': 'LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], LDL-C \\[\\<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight.'}, {'measure': 'Change From Baseline in Lipid Profile', 'timeFrame': 'Baseline, 26 weeks, 52 weeks', 'description': 'Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \\[≤8.5% and \\>8.5%\\], LDL-C \\[\\<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable\\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.'}, {'measure': 'Number of Participants With Change in Anti-LY2605541 Antibodies', 'timeFrame': 'Baseline through 52 weeks', 'description': 'The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '36542287', 'type': 'DERIVED', 'citation': 'Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.'}, {'pmid': '29167192', 'type': 'DERIVED', 'citation': 'Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.'}, {'pmid': '28587667', 'type': 'DERIVED', 'citation': 'Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.'}, {'pmid': '28417532', 'type': 'DERIVED', 'citation': 'Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.'}, {'pmid': '26577417', 'type': 'DERIVED', 'citation': 'Buse JB, Rodbard HW, Trescoli Serrano C, Luo J, Ivanyi T, Bue-Valleskey J, Hartman ML, Carey MA, Chang AM; IMAGINE 5 Investigators. Randomized Clinical Trial Comparing Basal Insulin Peglispro and Insulin Glargine in Patients With Type 2 Diabetes Previously Treated With Basal Insulin: IMAGINE 5. Diabetes Care. 2016 Jan;39(1):92-100. doi: 10.2337/dc15-1531. Epub 2015 Nov 17.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:\n\n* Change in participants' overall blood sugar control\n* The rate of night time low blood sugar episodes\n* The number of participants that reach blood sugar targets without low blood sugar episodes at night\n* The rate of low blood sugar episodes reported over a 24-hour period"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have had type 2 diabetes mellitus for at least 1 year\n* Have been receiving basal insulin (neutral protamine Hagedorn \\[NPH\\], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose\n* Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening\n* Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m\\^2)\n* Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug\n\nExclusion Criteria:\n\n* Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks\n* Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening\n* For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations\n* Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss\n* Have had any episodes of severe hypoglycemia within 6 months prior to screening\n* Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening\n* Have cardiac disease with functional status that is New York Heart Association Class III or IV\n* Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter \\[µmol/L\\])\n* Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \\[NAFLD\\]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements\n* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c\n* Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator\n* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening\n* Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter \\[mmol/L\\]) at screening\n* Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion\n* Lipid-lowering medication: Are using or have used any of the following:\n\n * niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or\n * lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening"}, 'identificationModule': {'nctId': 'NCT01582451', 'acronym': 'IMAGINE 5', 'briefTitle': 'A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Comparison of LY2605541 Versus Insulin Glargine Alone or in Combination With Pre-study Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Study', 'orgStudyIdInfo': {'id': '14703'}, 'secondaryIdInfos': [{'id': 'I2R-MC-BIDJ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2605541', 'description': 'Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications (OAMs) whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.', 'interventionNames': ['Drug: LY2605541']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin glargine', 'description': 'Administered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAMs whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.', 'interventionNames': ['Drug: Insulin glargine']}], 'interventions': [{'name': 'LY2605541', 'type': 'DRUG', 'otherNames': ['Insulin peglispro'], 'armGroupLabels': ['LY2605541']}, {'name': 'Insulin glargine', 'type': 'DRUG', 'armGroupLabels': ['Insulin glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'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': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'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': '91978', 'city': 'Spring Valley', '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': 32.74477, 'lon': -116.99892}}, {'zip': '33316', 'city': 'Fort Lauderdale', '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': 26.12231, 'lon': -80.14338}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', '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': 28.24418, 'lon': -82.71927}}, {'zip': '32765', 'city': 'Oviedo', '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': 28.67, 'lon': -81.20812}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', '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': 34.02316, 'lon': -84.36159}}, {'zip': '60607', 'city': 'Chicago', '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': 41.85003, 'lon': -87.65005}}, {'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': '47402', 'city': 'Bloomington', 'state': 'Indiana', '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': 39.16533, 'lon': -86.52639}}, {'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': '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': '20852', 'city': 'Rockville', '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': 39.084, 'lon': -77.15276}}, {'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': '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': '08753', 'city': 'Toms River', 'state': 'New Jersey', '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': 39.95373, 'lon': -74.19792}}, {'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': '27609', 'city': 'Raleigh', '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': 35.7721, 'lon': -78.63861}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '43015', 'city': 'Delaware', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.29867, 'lon': -83.06797}}, {'zip': '38305', 'city': 'Jackson', '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': 35.61452, 'lon': -88.81395}}, {'zip': '38119', 'city': 'Memphis', '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': 35.14953, 'lon': -90.04898}}, {'zip': '78731', 'city': 'Austin', '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': 30.26715, 'lon': -97.74306}}, {'zip': '75251', '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': '78681', 'city': 'Round Rock', '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': 30.50826, 'lon': -97.6789}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', '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': 40.88939, 'lon': -111.88077}}, {'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': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', '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': 43.0389, 'lon': -87.90647}}, {'zip': '26601', 'city': 'Beroun', 'country': 'Czechia', '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': 49.96382, 'lon': 14.072}}, {'zip': '250 01', 'city': 'Brandýs nad Labem', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.18356, 'lon': 14.67244}}, {'zip': '181 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', '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': 49.97704, 'lon': 9.15214}}, {'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', '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': 49.4925, 'lon': 9.77361}}, {'zip': '49401', 'city': 'Damme', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.52157, 'lon': 8.19793}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '55624', 'city': 'Rhaunen', 'country': 'Germany', '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': 49.8638, 'lon': 7.34198}}, {'zip': '341 00', 'city': 'Chalcis', 'country': 'Greece', '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': 38.46354, 'lon': 23.60284}}, {'zip': '54639', 'city': 'Thessaloniki', 'country': 'Greece', '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': 40.64072, 'lon': 22.93493}}, {'zip': '18274', 'city': 'Acre', 'country': 'Israel', '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': 32.92814, 'lon': 35.07647}}, {'zip': '84350', 'city': 'Beersheba', 'country': 'Israel', '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': 31.25181, 'lon': 34.7913}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', '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': 32.01034, 'lon': 34.77918}}, {'zip': '16000', 'city': 'Nazareth', 'country': 'Israel', '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': 32.70087, 'lon': 35.29719}}, {'zip': '43452', 'city': 'Raanana', 'country': 'Israel', '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': 32.1836, 'lon': 34.87386}}, {'zip': '00961', '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': '00717', 'city': 'Ponce', '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': 18.01031, 'lon': -66.62398}}, {'zip': '020359', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '410169', 'city': 'Oradea', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '550245', 'city': 'Sibiu', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '630091', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '192012', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '46600', 'city': 'Alzira', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '11540', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '07010', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '44001', 'city': 'Teruel', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.3456, 'lon': -1.10646}}], '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'}}}}