Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT00666718
Status:
COMPLETED
Last Update Posted:
2011-05-13
First Post:
2008-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], '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'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, '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': 'Glargine/Lispro', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin', 'otherNumAtRisk': 187, 'otherNumAffected': 81, 'seriousNumAtRisk': 187, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Lispro/Metformin', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin', 'otherNumAtRisk': 187, 'otherNumAffected': 65, 'seriousNumAtRisk': 187, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 39, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary artery perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial infarction', 'notes': 'This event resulted in death.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroduodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema mucosal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chondromalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Physiotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assuming a drop-out rate after randomization of approximately 15%, the remaining 160 patients in each treatment group should allow confirmation of noninferiority with no true treatment difference and a noninferiority limit of 0.4% using the upper limit of a 2-sided 95% confidence interval ("insulin lispro protamine suspension + insulin lispro" minus "insulin glargine+insulin lispro") at a significance level of 0.025 with 90% power.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.', 'unitOfMeasure': 'Percent of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'title': 'Week 12 Change (n=172, n=168)', 'categories': [{'measurements': [{'value': '-0.99', 'groupId': 'OG000', 'lowerLimit': '-1.14', 'upperLimit': '-0.84'}, {'value': '-0.90', 'groupId': 'OG001', 'lowerLimit': '-1.10', 'upperLimit': '-0.69'}]}]}, {'title': 'Week 24 Change (n=170, n=166)', 'categories': [{'measurements': [{'value': '-1.29', 'groupId': 'OG000', 'lowerLimit': '-1.45', 'upperLimit': '-1.13'}, {'value': '-1.07', 'groupId': 'OG001', 'lowerLimit': '-1.28', 'upperLimit': '-0.86'}]}]}], 'analyses': [{'pValue': '0.4580', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for Week 12 Change.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change from baseline=Treatment+country+baseline HbA1c+week+treatment\\*country+treatment\\*week+baseline HbA1c\\*treatment (unstructured covariance used).', 'testedNonInferiority': False}, {'pValue': '0.1070', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for Week 24 Change.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change from baseline=Treatment+country+baseline HbA1c+week+treatment\\*country+treatment\\*week+baseline HbA1c\\*treatment (unstructured covariance used).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.', 'unitOfMeasure': 'Percent of Glycosylated Hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'title': 'HbA1c < 7.0%', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <= 6.5%', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1333', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for HbA1c \\<7.0%.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1213', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for HbA1c \\<=6.5%', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All patients who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': '7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'title': 'Morning Pre-Meal', 'categories': [{'measurements': [{'value': '8.26', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '8.63', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Morning Postprandial', 'categories': [{'measurements': [{'value': '8.93', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '9.19', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Midday Pre-Meal', 'categories': [{'measurements': [{'value': '8.19', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '7.90', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Midday Postprandial', 'categories': [{'measurements': [{'value': '9.11', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '9.58', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Evening Pre-Meal', 'categories': [{'measurements': [{'value': '8.80', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '8.75', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Evening Postprandial', 'categories': [{'measurements': [{'value': '9.27', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '9.73', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': '0300 Hours', 'categories': [{'measurements': [{'value': '8.16', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '8.30', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '1.17', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Morning Pre-Meal measurement = Treatment+country+week+treatment\\*country + treatment\\*week (unstructured covariance was used)', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Morning Postprandial measurement = Treatment +country+week+treatment\\*country + treatment\\*week (unstructured covariance was used)', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.57', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Midday Pre-Meal measurement = Treatment +country + week +treatment\\*country + treatment\\*week (unstructured covariance was used).', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '1.40', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Midday Postprandial measurement = Treatment+country+week+treatment\\*country + treatment\\*week (unstructured covariance was used).', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '0.83', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Evening Pre-Meal measurement = Treatment +country+week+treatment\\*country + treatment\\*week (unstructured covariance was used).', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '1.34', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Evening Postprandial measurement = Treatment+country+week +treatment\\*country + treatment\\*week (unstructured covariance was used).', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.96', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '0300 Hours measurement = Treatment+country+week+treatment\\*country+treatment\\*week (unstructured covariance was used).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'Glycemic Variability at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'title': 'Fasting', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Post-breakfast', 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Post-lunch', 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Post-dinner', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5568', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for Fasting.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\\*country (Mediterranean, rest of Europe)', 'testedNonInferiority': False}, {'pValue': '0.7523', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for Post-breakfast.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\\*country (Mediterranean, rest of Europe)', 'testedNonInferiority': False}, {'pValue': '0.6448', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for Post-lunch.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\\*country (Mediterranean, rest of Europe)', 'testedNonInferiority': False}, {'pValue': '0.9122', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for Post-dinner.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+ treatment\\*country (Mediterranean, rest of Europe)', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'Rate Of All Self-reported Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'title': 'All reported episodes rate', 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal reported episodes rate', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Non-Nocturnal reported episodes rate', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Severe reported episodes rate', 'categories': [{'measurements': [{'value': '0', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.029', 'groupId': 'OG001'}]}]}, {'title': 'Documented <=3.9 millimoles per liter(mmol/L) rate', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Documented <=3.0 mmol/L rate', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '0.12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\\*Country+Treatment\\*Week (unstructured covariance structure was used)', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\\*Country+Treatment\\*Week (unstructured covariance structure was used)', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.16', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\\*Country+Treatment\\*Week (unstructured covariance structure was used)', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.06', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\\*Country+Treatment\\*Week (unstructured covariance structure was used)', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hypoglycemia rate per 30 days=Treatment+Country+Week+Treatment\\*Country+Treatment\\*Week (unstructured covariance structure was used)', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Week 24', 'description': 'Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose \\<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.', 'unitOfMeasure': 'episode/30 days/participant', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population - all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Self-Reported Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'title': '>=1 hypoglycemic episode', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '56.1', 'groupId': 'OG001'}]}]}, {'title': '>=1 nocturnal hypoglycemic episode', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000'}, {'value': '25.7', 'groupId': 'OG001'}]}]}, {'title': '>=1 non-nocturnal hypoglycemic episode', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '54.0', 'groupId': 'OG001'}]}]}, {'title': '>=1 severe hypoglycemic episode', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1701', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for \\>=1 hypoglycemic episode.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1727', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for \\>=1 nocturnal hypoglycemic episode.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2094', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for \\>=1 non-nocturnal hypoglycemic episode.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6230', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for \\>=1 severe hypoglycemic episode.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 24', 'description': 'Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value \\<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population - all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events (SAE)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 24', 'description': 'A listing of adverse events is located in the Reported Adverse Event module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population - all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.55', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'weight change from baseline = Treatment + country + baseline Hb1Ac + baseline weight + treatment\\*HbA1c baseline value', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'LSMean values presented were controlled for treatment, country, and baseline HbA1C value.', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.'}, {'type': 'SECONDARY', 'title': 'Total Daily Insulin Dose at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '78.05', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '80.23', 'spread': '4.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '-8.33', 'ciUpperLimit': '12.68', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Total daily insulin dose=Treatment+country+week+treatment\\*country+ treatment\\*week (unstructured covariance was used).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'LSMean values presented were controlled for treatment, country, and baseline HbA1C value.', 'unitOfMeasure': 'Units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'Number of Injections of Insulin at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks'}, {'id': 'OG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks'}], 'classes': [{'title': '2 to <3 per day', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '3 to <4 per day', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': '≥4 per day', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin'}, {'id': 'FG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections) plus metformin'}, {'id': 'BG001', 'title': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '8.07', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '8.36', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '8.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Insulin Injections/Inhalations Per Day', 'classes': [{'title': '1 Insulin Injection/Inhalation per day', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}, {'title': '2 Insulin Injections/Inhalations per day', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': '3 Insulin Injections/Inhalations per day', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': '4 Insulin Injections/Inhalations per day', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': '>=5 Insulin Injections/Inhalations per day', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Missing Data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The number of insulin injections/inhalations is calculated as the sum of injections per day from the most recently applied insulins before randomization.', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '93.53', 'spread': '17.168', 'groupId': 'BG000'}, {'value': '90.60', 'spread': '17.075', 'groupId': 'BG001'}, {'value': '92.06', 'spread': '17.161', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '33.27', 'spread': '5.040', 'groupId': 'BG000'}, {'value': '33.00', 'spread': '5.004', 'groupId': 'BG001'}, {'value': '33.13', 'spread': '5.017', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.83', 'spread': '0.896', 'groupId': 'BG000'}, {'value': '8.82', 'spread': '0.895', 'groupId': 'BG001'}, {'value': '8.82', 'spread': '0.894', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '7.04', 'groupId': 'BG000'}, {'value': '11.8', 'spread': '6.66', 'groupId': 'BG001'}, {'value': '12.3', 'spread': '6.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Previous Insulin Treatment', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '25.65', 'groupId': 'BG000'}, {'value': '37.6', 'spread': '25.75', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '25.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The dose is calculated as the total dose from the most recently applied previous insulins before randomization.', 'unitOfMeasure': 'Units (IU)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 374}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-11', 'studyFirstSubmitDate': '2008-04-23', 'resultsFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-18', 'studyFirstPostDateStruct': {'date': '2008-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 12 and Week 24', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.'}, {'measure': 'Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint', 'timeFrame': 'Week 24'}, {'measure': '7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint', 'timeFrame': '24 weeks', 'description': 'LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.'}, {'measure': 'Glycemic Variability at Endpoint', 'timeFrame': 'Week 24', 'description': 'LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.'}, {'measure': 'Rate Of All Self-reported Hypoglycemic Episodes', 'timeFrame': 'Baseline through Week 24', 'description': 'Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose \\<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.'}, {'measure': 'Percentage of Participants With Self-Reported Hypoglycemic Episodes', 'timeFrame': 'Baseline through Week 24', 'description': 'Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value \\<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.'}, {'measure': 'Number of Participants With Adverse Events (AE)', 'timeFrame': 'Baseline through Week 24', 'description': 'A listing of adverse events is located in the Reported Adverse Event module.'}, {'measure': 'Change in Body Weight From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'LSMean values presented were controlled for treatment, country, and baseline HbA1C value.'}, {'measure': 'Total Daily Insulin Dose at Endpoint', 'timeFrame': 'Week 24', 'description': 'LSMean values presented were controlled for treatment, country, and baseline HbA1C value.'}, {'measure': 'Number of Injections of Insulin at Week 24', 'timeFrame': 'Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes Mellitus, Type 2\n* Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)\n* Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%\n* Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m\\^2\n* Capable and willing to follow the protocol\n* Give written consent\n\nExclusion Criteria:\n\n* Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)\n* Have a history of severe hypoglycemia in the past 6 months\n* Are pregnant or may become pregnant\n* Women who are breastfeeding\n* Have significant cardiac disease\n* Have significant renal or liver disease\n* Undergoing therapy for a malignancy\n* Contraindications to the study medications\n* Have an irregular sleep/wake cycle\n* Have a serious disease or any condition considered by the investigator to be exclusionary'}, 'identificationModule': {'nctId': 'NCT00666718', 'briefTitle': 'A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '12047'}, 'secondaryIdInfos': [{'id': 'F3Z-EW-IOPJ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glargine', 'description': 'Glargine plus Insulin Lispro (2-3 injections)', 'interventionNames': ['Drug: Insulin Glargine', 'Drug: Insulin Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'ILPS', 'description': 'Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)', 'interventionNames': ['Drug: Insulin Lispro Protamine Suspension (ILPS)', 'Drug: Insulin Lispro']}], 'interventions': [{'name': 'Insulin Glargine', 'type': 'DRUG', 'description': 'patient glucose-level dependent, injection, once daily in the evening, 24 weeks', 'armGroupLabels': ['Glargine']}, {'name': 'Insulin Lispro Protamine Suspension (ILPS)', 'type': 'DRUG', 'otherNames': ['LY275585'], 'description': 'patient glucose-level dependent, injection, once daily in the evening, 24 weeks', 'armGroupLabels': ['ILPS']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'description': 'subcutaneous injections prior to meals, 24 weeks', 'armGroupLabels': ['Glargine', 'ILPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'country': 'Belgium', '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': 50.965, 'lon': 5.50082}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', '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': 50.87959, 'lon': 4.70093}}, {'zip': '2830', 'city': 'Willebroek', 'country': 'Belgium', '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': 51.06041, 'lon': 4.36019}}, {'zip': '769 01', 'city': 'Holešov', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.33331, 'lon': 17.57832}}, {'zip': '753 01', 'city': 'Hranice I-Mesto', '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.'}, {'zip': '77200', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '709 00', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '301 66', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '149 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': 'D-97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': 'D-12351', 'city': 'Berlin', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-49401', 'city': 'Damme', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.52157, 'lon': 8.19793}}, {'zip': 'D-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': 'D-22177', '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': '30519', 'city': 'Hanover', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '01796', 'city': 'Pirna', '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': 50.95843, 'lon': 13.93702}}, {'zip': 'D-36199', 'city': 'Rotenburg-Fulda', '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': '11526', 'city': 'Athens', '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': 37.98376, 'lon': 23.72784}}, {'zip': '41221', 'city': 'Larissa', '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': 39.62847, 'lon': 22.42112}}, {'zip': '56429', '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': '60131', 'city': 'Ancona', 'country': 'Italy', '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': 43.60717, 'lon': 13.5103}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', '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': 41.12066, 'lon': 16.86982}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', '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': 42.78235, 'lon': 12.59836}}, {'zip': '35143', 'city': 'Padua', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '51100', 'city': 'Pistoia', 'country': 'Italy', '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': 43.93064, 'lon': 10.92365}}, {'zip': '48100', 'city': 'Ravenna', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '00189', 'city': 'Rome', 'country': 'Italy', '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': 41.89193, 'lon': 12.51133}}, {'zip': '66-400', 'city': 'Gorzów Wielkopolski', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.73371, 'lon': 15.22505}}, {'zip': '31-159', 'city': 'Krakow', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '93-338', 'city': 'Lodz', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '59-301', 'city': 'Lubin', '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': 51.40089, 'lon': 16.20149}}, {'zip': '39-300', 'city': 'Mielec', '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': 50.28709, 'lon': 21.4239}}, {'zip': '61-696', 'city': 'Poznan', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-577', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '503-349', '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': '430071', 'city': 'Baia Mare', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'zip': '020475', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Sf Gheorghe', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '97405', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '821 06', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '900 01', 'city': 'Modra', 'country': 'Slovakia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.33397, 'lon': 17.30711}}, {'zip': '94901', 'city': 'Nitra', 'country': 'Slovakia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.30763, 'lon': 18.08453}}, {'zip': '35100', 'city': 'Bornova', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.47921, 'lon': 27.2399}}, {'zip': '34662', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', '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': 41.01384, 'lon': 28.94966}}, {'zip': '35360', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': 'EH3 9YW', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', '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': 53.38297, 'lon': -1.4659}}, {'zip': 'CV22 5PX', 'city': 'Rugby', 'state': 'Warwickshire', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.37092, 'lon': -1.26417}}, {'zip': 'B71 4HJ', 'city': 'West Bromwich', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.51868, 'lon': -1.9945}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}