Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-28 @ 1:14 AM
Study NCT ID:
NCT01421459
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2011-08-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Adults With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'Romania', 'Russia', 'Slovakia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'C000606659', 'term': 'LY2963016 insulin glargine'}, {'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': {'eventGroups': [{'id': 'EG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks', 'otherNumAtRisk': 376, 'otherNumAffected': 188, 'seriousNumAtRisk': 376, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks', 'otherNumAtRisk': 380, 'otherNumAffected': 175, 'seriousNumAtRisk': 380, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 27, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abnormal loss of weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abnormal weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myocardial infarction', 'notes': 'Event resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coeliac disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Open wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lung adenocarcinoma', 'notes': 'Event resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lung carcinoma cell type unspecified recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Subclavian artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.286', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.338', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.403', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.052', 'ciLowerLimit': '-0.070', 'ciUpperLimit': '0.175', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week endpoint HbA1c for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Endpoint (up to 24 weeks)', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin Antibody Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Change at 4 weeks (n=10, 3)', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-3.25', 'spread': '2.79', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 weeks (n=9, 5)', 'categories': [{'measurements': [{'value': '-1.57', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-4.39', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 weeks (n=10, 2)', 'categories': [{'measurements': [{'value': '-2.61', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Change at Endpoint, up to 24 weeks (n=14, 6)', 'categories': [{'measurements': [{'value': '-2.49', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-3.11', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)', 'description': 'Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.', 'unitOfMeasure': 'percentage of insulin antibody binding', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline insulin antibody measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Change at 4 weeks (n=368, 371)', 'categories': [{'measurements': [{'value': '-0.452', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.481', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Change at 8 weeks (n=359, 358)', 'categories': [{'measurements': [{'value': '-0.871', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.866', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 weeks (n=349, 351)', 'categories': [{'measurements': [{'value': '-1.134', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.143', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Change at 16 weeks (n=345, 345)', 'categories': [{'measurements': [{'value': '-1.265', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.321', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Change at 20 weeks (n=338, 334)', 'categories': [{'measurements': [{'value': '-1.294', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.379', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 weeks (n=331, 329)', 'categories': [{'measurements': [{'value': '-1.336', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.438', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.382', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.910', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 8 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.869', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.345', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 16 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 20 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure.'}, {'type': 'SECONDARY', 'title': '7-Point Self-Monitored Blood Glucose (SMBG) Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Baseline- AM Pre-Meal (n=353, 359)', 'categories': [{'measurements': [{'value': '8.82', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '8.86', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Baseline- AM 2 hrs PP (n=356, 356)', 'categories': [{'measurements': [{'value': '11.68', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '11.80', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Baseline- MD Pre-Meal (n=357, 357)', 'categories': [{'measurements': [{'value': '9.09', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '9.44', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline- MD 2 hrs PP (n=357, 353)', 'categories': [{'measurements': [{'value': '10.65', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '10.89', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline- EV Pre-Meal (n=356, 354)', 'categories': [{'measurements': [{'value': '9.29', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '9.59', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline- Bed Time (n=355, 354)', 'categories': [{'measurements': [{'value': '11.25', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '11.17', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Baseline- 0300 hrs (n=342, 341)', 'categories': [{'measurements': [{'value': '8.83', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '8.96', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 wk- AM Pre-Meal (n=353, 359)', 'categories': [{'measurements': [{'value': '5.94', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '6.06', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 wk- AM 2 hrs PP (n=356, 356)', 'categories': [{'measurements': [{'value': '8.07', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '8.40', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 wk- MD Pre-Meal (n=357, 357)', 'categories': [{'measurements': [{'value': '6.81', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '7.12', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 wk- MD 2 hrs PP (n=357, 353)', 'categories': [{'measurements': [{'value': '8.53', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '8.69', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 wk- EV Pre-Meal (n=356, 354)', 'categories': [{'measurements': [{'value': '7.29', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '7.40', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 wk- Bed Time (n=355, 354)', 'categories': [{'measurements': [{'value': '8.56', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '8.67', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 wk- 0300 hrs (n=342, 341)', 'categories': [{'measurements': [{'value': '6.72', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '6.70', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.837', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is at Morning Pre-Meal at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.620', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Morning 2 hrs PP Meal at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Midday Pre-Meal at Baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.258', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Midday 2 hrs PP Meal at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Evening Pre-Meal at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.725', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Bed Time at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.543', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 0300 hrs at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.265', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Morning Pre-Meal at Endpoint, up to 24 wk.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.050', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Morning 2 hrs PP Meal at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Midday Pre-Meal at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.366', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Midday 2 hrs PP Meal at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.485', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Evening Pre-Meal at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.537', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Bed Time at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.878', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 0300 hrs at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Endpoint [up to 24 weeks (wk)]', 'description': 'Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Glycemic Variability of Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 weeks', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.779', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.788', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Endpoint (up to 24 weeks)', 'description': 'Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose \\[SMBG\\] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Change at 4 wk (n=361, 364)', 'categories': [{'measurements': [{'value': '0.292', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.526', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Change at 8 wk (n=358, 357)', 'categories': [{'measurements': [{'value': '0.999', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.152', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 wk (n=350, 352)', 'categories': [{'measurements': [{'value': '1.271', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '1.440', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Change at 16 wk (n=342, 344)', 'categories': [{'measurements': [{'value': '1.550', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.918', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Change at 20 wk (n=340, 333)', 'categories': [{'measurements': [{'value': '1.734', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.234', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 wk (n=335, 329)', 'categories': [{'measurements': [{'value': '1.914', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '2.175', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Change at Endpoint, up to 24 wk (n=370, 374)', 'categories': [{'measurements': [{'value': '1.776', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.020', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.687', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for change at 4 wks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.323', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for change at 8 wks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for change at 12 wks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.089', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for change at 16 wks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for change at 20 wks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.330', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for change at 24 wks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.334', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for change at Endpoint, up to 24 wks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)', 'description': 'Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Adult Low Blood Sugar Survey (ALBSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Behavior Score- 4 wk (n=351, 354)', 'categories': [{'measurements': [{'value': '8.41', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '8.64', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Behavior Score- 12 wk (n=350, 349)', 'categories': [{'measurements': [{'value': '8.95', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '9.36', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Behavior Score- Endpoint up to 24 wk (n=368, 371)', 'categories': [{'measurements': [{'value': '7.90', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '8.36', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Worry Score- 4 wk (n=352, 354)', 'categories': [{'measurements': [{'value': '7.74', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '8.82', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Worry Score- 12 wk (n=349, 348)', 'categories': [{'measurements': [{'value': '8.35', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '8.51', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Worry Score- Endpoint up to 24 wk (n=368, 371)', 'categories': [{'measurements': [{'value': '8.61', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '8.57', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'ALBSS Total Score- 4 wk (n=352, 354)', 'categories': [{'measurements': [{'value': '16.15', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '17.45', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'ALBSS Total Score- 12 wk (n=349, 348)', 'categories': [{'measurements': [{'value': '17.32', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '17.85', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'ALBSS Total Score-Endpoint up to 24 wk (n=368,371)', 'categories': [{'measurements': [{'value': '16.53', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '16.92', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.726', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Behavior domain at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.502', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Behavior domain at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Behavior domain at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.237', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Worry domain at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.860', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Worry domain at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.966', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Worry domain at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for ALBSS Total Score at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.683', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for ALBSS Total Score at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.765', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for ALBSS Total Score at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)', 'description': 'ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ALBSS measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Insulin Treatment Satisfaction Questionnaire (ITSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'IR- 4 wk (n=352, 354)', 'categories': [{'measurements': [{'value': '86.10', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '86.12', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'IR- 12 wk (n=350, 348)', 'categories': [{'measurements': [{'value': '83.44', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '84.54', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'IR- EP, up to 24 wk (n=368, 371)', 'categories': [{'measurements': [{'value': '85.62', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '85.21', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'LF- 4 wk (n=352, 354)', 'categories': [{'measurements': [{'value': '79.65', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '79.87', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'LF-12 wk (n=350, 350)', 'categories': [{'measurements': [{'value': '76.69', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '78.16', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'LF- EP, up to 24 wk (n=368, 372)', 'categories': [{'measurements': [{'value': '78.00', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '78.32', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'HC- 4 wk (n=352, 354)', 'categories': [{'measurements': [{'value': '79.36', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '80.33', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'HC- 12 wk (n=350, 348)', 'categories': [{'measurements': [{'value': '77.15', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '77.73', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'HC- EP, up to 24 wk (n=368, 372)', 'categories': [{'measurements': [{'value': '77.51', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '79.08', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'GC- 4 wk (n=352, 354)', 'categories': [{'measurements': [{'value': '75.67', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '75.47', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'GC- 12 wk (n=350, 347)', 'categories': [{'measurements': [{'value': '78.95', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '81.38', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'GC- EP, up to 24 wk (n=368, 372)', 'categories': [{'measurements': [{'value': '80.74', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '80.26', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'IDD- 4 wk (n=352, 353)', 'categories': [{'measurements': [{'value': '70.56', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '73.22', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'IDD- 12 wk (n=348, 349)', 'categories': [{'measurements': [{'value': '70.97', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '72.21', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'IDD- EP, up to 24 wk (n=368, 372)', 'categories': [{'measurements': [{'value': '72.85', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '73.87', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'ITSQ Overall Total- 4 wk (n=352, 354)', 'categories': [{'measurements': [{'value': '78.02', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '78.98', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'ITSQ Overall Total- 12 wk (n=349, 348)', 'categories': [{'measurements': [{'value': '77.06', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '78.30', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'ITSQ Overall Total- EP, up to 24 wk (n=368, 372)', 'categories': [{'measurements': [{'value': '78.54', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '79.06', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.983', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Inconvenience of Regimen at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.371', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Inconvenience of Regimen at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.757', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Inconvenience of Regimen at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.890', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Lifestyle Flexibility at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.326', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Lifestyle Flexibility at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.831', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Lifestyle Flexibility at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.507', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Hypoglycemic Control at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.690', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Hypoglycemic Control at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.307', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Hypoglycemic Control at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.902', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Glycemic Control at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.109', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Glycemic Control at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.754', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Glycemic Control at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.088', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Insulin Deliver Device at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.456', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Insulin Delivery Device at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.531', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Insulin Delivery Device at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.393', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for ITSQ Total Score at 4 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.296', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for ITSQ Total Score at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.662', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for ITSQ Total Score at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)', 'description': 'ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen \\[(IR) 5 items: domain scores range (DSR) 5-35\\], Lifestyle Flexibility \\[(LF) 3 items: DSR 3-21\\], Glycemic Control \\[(GC) 3 items: DSR 3-21\\], Hypoglycemic Control \\[(HC) 5 items: DSR 5-35\\], Insulin Delivery Device \\[(IDD) 6 items: DSR 6-42\\]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100\\*\\[(7-mean raw score)/6\\]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Insulin Dose Per Body Weight (U/kg) Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.500', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.479', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.393', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Endpoint (up to 24 weeks)', 'description': 'Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.', 'unitOfMeasure': 'units per kilogram per day (U/kg/day)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Insulin Dose per Body Weight measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (Units)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '44.465', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '41.015', 'spread': '2.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.185', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Insulin Dose at Endpoint, up to 24 weeks.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Endpoint (up to 24 weeks)', 'description': 'Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.', 'unitOfMeasure': 'units per day (U/day)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline insulin dose measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'HbA1c- at Baseline < 7.0 % (n=369, 375)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at Baseline ≤ 6.5% (n=369, 375)', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 4 weeks < 7% (n=368, 371)', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 4 week ≤ 6.5%(n=368, 371)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 8 weeks < 7% (n=359, 358)', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000'}, {'value': '29.9', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 8 weeks ≤ 6.5% (n=359, 358)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 12 weeks <7% (n=349, 351)', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '43.0', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 12 weeks ≤ 6.5% (n=349, 351)', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 16 weeks <7% (n=345, 345)', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '52.8', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 16 weeks ≤ 6.5% (n=345, 345)', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '28.4', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 20 weeks < 7% (n=338, 334)', 'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000'}, {'value': '54.2', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 20 weeks ≤ 6.5% (n=338, 334)', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '32.6', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 24 weeks < 7% (n=331, 329)', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000'}, {'value': '55.9', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- at 24 weeks ≤ 6.5% (n=331, 329)', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- Endpoint, up to 24 weeks <7% (n=369, 375)', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '52.5', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c- Endpoint, up to 24 weeks ≤ 6.5% (n=369,375)', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.661', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c \\<7% at Baseline.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.394', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c ≤ 6.5% at Baseline.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.688', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c \\<7% at 4 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c ≤ 6.5% at 4 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.409', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c \\<7% at 8 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.090', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c ≤ 6.5% at 8 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.319', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c \\<7% at 12 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.463', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c ≤6.5% at 12 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c \\<7% at 16 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.261', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c ≤6.5% at 16 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.218', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c \\<7% at 20 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.092', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c ≤6.5% at 20 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.186', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c \\<7%% at 24 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.174', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c ≤6.5% at 24 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.340', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c \\<7% at Endpoint, up to 24 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.293', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for HbA1c ≤6.5% at Endpoint, up to 24 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)', 'description': 'Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Total Events with BG ≤70 mg/dL', 'categories': [{'measurements': [{'value': '3564', 'groupId': 'OG000'}, {'value': '3845', 'groupId': 'OG001'}]}]}, {'title': 'Severe Events', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal Events with BG ≤70 mg/dL', 'categories': [{'measurements': [{'value': '1248', 'groupId': 'OG000'}, {'value': '1386', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.594', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Total Hypoglycemic with BG ≤70 mg/dL events.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.462', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Nocturnal Hypoglycemic with BG ≤70 mg/dL events.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Endpoint (up to 24 weeks)', 'description': 'A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.', 'unitOfMeasure': 'hypoglycemic events in 24 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline hypoglycemic event measure.'}, {'type': 'SECONDARY', 'title': 'Rate Per 30 Days of Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Total Hypoglycemia with BG ≤70 mg/dL', 'categories': [{'measurements': [{'value': '1.75', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '2.32', 'groupId': 'OG001'}]}]}, {'title': 'Severe Hypoglycemia', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal Hypoglycemia with BG ≤70 mg/dL', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.995', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Total Hypoglycemia with BG ≤70 mg/dL events.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.686', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Nocturnal Hypoglycemia with BG ≤70 mg/dL events.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Endpoint (up to 24 weeks)', 'description': 'The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.', 'unitOfMeasure': 'hypoglycemic events per 30 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Detectable Insulin Antibody Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': 'Baseline (n=365, 365)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': '4 weeks (n=362, 359)', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': '12 weeks (n= 351, 344)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}, {'title': '24 weeks (n=337, 328)', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 weeks (n= 365, 365)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 24 weeks (Overall) (n= 365, 365)', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '11.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.285', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Baseline.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 4 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.882', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 12 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 24 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.314', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Endpoint, up to 24 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Baseline to 24 weeks (Overall).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Treatment Emergent Antibody Response (TEAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'OG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'classes': [{'title': '4 weeks (n= 362, 359)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': '12 weeks (n= 351, 344)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': '24 weeks (n=337, 328)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint, up to 24 weeks (n= 365, 365)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Overall (n= 365, 365)', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.176', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 4 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.999', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 12 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.618', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 24 weeks.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.874', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Endpoint (LOCF).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.233', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Overall (Baseline to 24 weeks).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)', 'description': 'TEAR is defined as an absolute increase of at least 1% in insulin antibody levels (measured in % binding) and at least 30% relative increase from Baseline for participants who are insulin antibody-positive at Baseline, or turning from insulin antibody-negative status at Baseline to antibody-positive during the course of the study following treatment with study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'FG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}, {'groupId': 'FG001', 'numSubjects': '380'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}, {'groupId': 'FG001', 'numSubjects': '380'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '334'}, {'groupId': 'FG001', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '756', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks'}, {'id': 'BG001', 'title': 'Lantus + OAMs', 'description': 'Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.98', 'spread': '10.17', 'groupId': 'BG000'}, {'value': '58.67', 'spread': '10.02', 'groupId': 'BG001'}, {'value': '58.82', 'spread': '10.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '593', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.34', 'spread': '1.09', 'groupId': 'BG000'}, {'value': '8.31', 'spread': '1.06', 'groupId': 'BG001'}, {'value': '8.33', 'spread': '1.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sulfonylurea Use', 'classes': [{'title': 'Yes, did use sulfonylurea', 'categories': [{'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '630', 'groupId': 'BG002'}]}]}, {'title': 'No, did not use sulfonylurea', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants who used or did not use sulfonylurea.', 'unitOfMeasure': 'participants'}, {'title': 'Time of Basal Insulin Injection', 'classes': [{'title': 'Daytime', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}]}, {'title': 'Evening/Bedtime', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants who administered a basal insulin injection during the Daytime and Evening/Bedtime.', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '90.35', 'spread': '20.02', 'groupId': 'BG000'}, {'value': '89.83', 'spread': '19.25', 'groupId': 'BG001'}, {'value': '90.09', 'spread': '19.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 759}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'dispFirstSubmitDate': '2013-01-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2011-08-19', 'dispFirstSubmitQcDate': '2013-01-11', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2011-08-19', 'dispFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-03', 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Detectable Insulin Antibody Levels', 'timeFrame': 'Baseline and 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)'}, {'measure': 'Percentage of Participants With Treatment Emergent Antibody Response (TEAR)', 'timeFrame': '4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)', 'description': 'TEAR is defined as an absolute increase of at least 1% in insulin antibody levels (measured in % binding) and at least 30% relative increase from Baseline for participants who are insulin antibody-positive at Baseline, or turning from insulin antibody-negative status at Baseline to antibody-positive during the course of the study following treatment with study drug.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Endpoint (up to 24 weeks)', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Insulin Antibody Levels', 'timeFrame': 'Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)', 'description': 'Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.'}, {'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.'}, {'measure': '7-Point Self-Monitored Blood Glucose (SMBG) Profiles', 'timeFrame': 'Baseline and Endpoint [up to 24 weeks (wk)]', 'description': 'Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.'}, {'measure': 'Glycemic Variability of Fasting Blood Glucose', 'timeFrame': 'Baseline and Endpoint (up to 24 weeks)', 'description': 'Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose \\[SMBG\\] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)', 'description': 'Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.'}, {'measure': 'Adult Low Blood Sugar Survey (ALBSS)', 'timeFrame': '4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)', 'description': 'ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.'}, {'measure': 'Insulin Treatment Satisfaction Questionnaire (ITSQ)', 'timeFrame': '4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)', 'description': 'ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen \\[(IR) 5 items: domain scores range (DSR) 5-35\\], Lifestyle Flexibility \\[(LF) 3 items: DSR 3-21\\], Glycemic Control \\[(GC) 3 items: DSR 3-21\\], Hypoglycemic Control \\[(HC) 5 items: DSR 5-35\\], Insulin Delivery Device \\[(IDD) 6 items: DSR 6-42\\]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100\\*\\[(7-mean raw score)/6\\]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.'}, {'measure': 'Insulin Dose Per Body Weight (U/kg) Per Day', 'timeFrame': 'Endpoint (up to 24 weeks)', 'description': 'Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.'}, {'measure': 'Insulin Dose (Units)', 'timeFrame': 'Endpoint (up to 24 weeks)', 'description': 'Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.'}, {'measure': 'Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%', 'timeFrame': 'Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)', 'description': 'Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.'}, {'measure': 'Incidence of Hypoglycemic Events', 'timeFrame': 'Baseline and Endpoint (up to 24 weeks)', 'description': 'A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.'}, {'measure': 'Rate Per 30 Days of Hypoglycemic Events', 'timeFrame': 'Baseline, Endpoint (up to 24 weeks)', 'description': 'The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Type 2 Diabetes'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '29855972', 'type': 'DERIVED', 'citation': 'Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.'}, {'pmid': '29542012', 'type': 'DERIVED', 'citation': 'Pollom RK, Costigan T, Lacaya LB, Ilag LL, Hollander PA. Similar Efficacy and Safety of Basaglar(R) and Lantus(R) in Patients with Type 2 Diabetes in Age Groups (< 65 Years, >/= 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. Diabetes Ther. 2018 Apr;9(2):827-837. doi: 10.1007/s13300-018-0405-5. Epub 2018 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification\n* Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study\n* Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent\n* Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m\\^2)\n\nExclusion Criteria:\n\n* Have significant liver, cardiac or gastrointestinal disease\n* Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)\n* Have an excessive resistance to insulin or hypersensitivity to Lantus\n* Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study\n* Have taken any other insulin other than Lantus within the past 30 days\n* Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin'}, 'identificationModule': {'nctId': 'NCT01421459', 'acronym': 'ELEMENT 2', 'briefTitle': 'A Study in Adults With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study', 'orgStudyIdInfo': {'id': '13713'}, 'secondaryIdInfos': [{'id': 'I4L-MC-ABEC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2011-000828-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2963016 + OAMs', 'description': 'LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) \\[alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)\\] administered per standard of care for 24 weeks', 'interventionNames': ['Drug: LY2963016', 'Drug: OAMs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lantus + OAMs', 'description': 'Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks', 'interventionNames': ['Drug: Lantus', 'Drug: OAMs']}], 'interventions': [{'name': 'LY2963016', 'type': 'DRUG', 'description': 'Administered subcutaneously', 'armGroupLabels': ['LY2963016 + OAMs']}, {'name': 'Lantus', 'type': 'DRUG', 'description': 'Administered subcutaneously', 'armGroupLabels': ['Lantus + OAMs']}, {'name': 'OAMs', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY2963016 + OAMs', 'Lantus + OAMs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36106', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '34601', 'city': 'Brooksville', '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': 28.55554, 'lon': -82.38991}}, {'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': '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': '33028', 'city': 'Pembroke Pines', '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': 26.00315, 'lon': -80.22394}}, {'zip': '33617', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30329', 'city': 'Atlanta', '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': 33.749, 'lon': -84.38798}}, {'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': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '39150', 'city': 'Port Gibson', 'state': 'Mississippi', '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': 31.96099, 'lon': -90.98399}}, {'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': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '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': '11501', 'city': 'Mineola', 'state': 'New York', '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': 40.74927, 'lon': -73.64068}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', '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': 40.7351, 'lon': -73.68791}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', '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': 43.04812, 'lon': -76.14742}}, {'zip': '28803', 'city': 'Asheville', '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': 35.60095, 'lon': -82.55402}}, {'zip': '28144', 'city': 'Salisbury', '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': 35.67097, 'lon': -80.47423}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', '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': 46.87719, 'lon': -96.7898}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75246', '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': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76054', 'city': 'Hurst', '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': 32.82346, 'lon': -97.17057}}, {'zip': '75605', 'city': 'Longview', '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': 32.5007, 'lon': -94.74049}}, {'zip': '75093', 'city': 'Plano', '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': 33.01984, 'lon': -96.69889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'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': '15500', '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': '44300', 'city': 'Nantes', 'country': 'France', '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': 47.21725, 'lon': -1.55336}}, {'zip': '59690', 'city': 'Vieux-Condé', 'country': 'France', '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': 50.45944, 'lon': 3.56738}}, {'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': '01219', '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': '89537', 'city': 'Giengen an der Brenz', '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': 48.62219, 'lon': 10.24312}}, {'zip': '22607', 'city': 'Hamburg', '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': 53.55073, 'lon': 9.99302}}, {'zip': '69115', 'city': 'Heidelberg', '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': 49.40768, 'lon': 8.69079}}, {'zip': '21339', 'city': 'Lüneburg', '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': 53.2509, 'lon': 10.41409}}, {'zip': '66386', 'city': 'Saint Ingbert-Oberwürzbach', '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.'}, {'zip': '57010', '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': '1171', 'city': 'Budapest', 'country': 'Hungary', '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': 47.49835, 'lon': 19.04045}}, {'zip': '8500', 'city': 'Pápa', 'country': 'Hungary', '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': 47.33004, 'lon': 17.4674}}, {'zip': '04460', 'city': 'Guadalajara Jalisco', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '03300', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64710', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '89000', 'city': 'Tampico', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.28519, 'lon': -97.87777}}, {'zip': '15-404', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-858', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '41-709', 'city': 'Ruda Śląska', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.2584, 'lon': 18.85632}}, {'zip': '50-403', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '00983', 'city': 'Carolina', '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': 18.38078, 'lon': -65.95739}}, {'zip': '00674', 'city': 'Manatí', 'country': 'Puerto Rico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 18.42745, 'lon': -66.49212}}, {'zip': '00917-3104', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00909', 'city': 'Santurce', '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': 18.19523, 'lon': -67.14018}}, {'zip': '139-872', 'city': 'Seoul', 'country': 'South Korea', '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': 37.566, 'lon': 126.9784}}, {'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', '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': 35.53722, 'lon': 129.31667}}, {'zip': '29006', 'city': 'Málaga', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '07014', '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': '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}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '11031', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '71004', 'city': 'Yong Kung City', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}], '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'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}