Viewing Study NCT01683266

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Ignite Creation Date: 2025-12-24 @ 4:01 PM
Ignite Modification Date: 2026-01-27 @ 9:26 PM
Study NCT ID: NCT01683266
Status: COMPLETED
Last Update Posted: 2015-06-24
First Post: 2012-09-07
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': {'email': 'Contact--US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug.', 'description': "Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (as the time from first injection of IMP up to 2 days after the last injection of IMP). Analysis was done on safety population.", 'eventGroups': [{'id': 'EG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.', 'otherNumAtRisk': 274, 'otherNumAffected': 113, 'seriousNumAtRisk': 274, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.', 'otherNumAtRisk': 275, 'otherNumAffected': 86, 'seriousNumAtRisk': 275, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Open fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change In HbA1c From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.051', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.098', 'ciUpperLimit': '0.185', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.072', 'groupDescription': 'Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\\<8.0, \\>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:\n\n1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \\<0.4%.\n2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \\<0.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population: all randomized participants who received at least (\\>=)1 dose, had baseline and \\>=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c <7% at Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'SECONDARY', 'title': 'Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.16', 'spread': '0.223', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.233', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.982', 'ciUpperLimit': '0.287', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.322', 'groupDescription': 'Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\\<8.0, \\>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.', 'unitOfMeasure': 'millimole per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.'}, {'type': 'SECONDARY', 'title': 'Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.03', 'spread': '1.573', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '1.651', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.', 'unitOfMeasure': 'percentage of mean', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.95', 'spread': '0.263', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '0.260', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '12.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.'}, {'type': 'SECONDARY', 'title': 'Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'title': '03:00 at Night (n= 156, 159)', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '4.98', 'groupId': 'OG001'}]}]}, {'title': 'Pre--Breakfast (n= 166, 167)', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '5.20', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Breakfast (n= 152, 156)', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '4.75', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '5.66', 'groupId': 'OG001'}]}]}, {'title': 'Pre--Lunch (n= 166, 166)', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '4.76', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Lunch (n= 163,163)', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '5.20', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '5.37', 'groupId': 'OG001'}]}]}, {'title': 'Pre--Dinner (n= 165,166)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '-1.74', 'spread': '5.28', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Dinner (n= 154,152)', 'categories': [{'measurements': [{'value': '-0.93', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '5.51', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime (n= 141,146)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '5.39', 'groupId': 'OG000'}, {'value': '-1.91', 'spread': '5.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point.'}, {'type': 'SECONDARY', 'title': 'Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'unitOfMeasure': 'U/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.'}, {'type': 'SECONDARY', 'title': 'Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '0.331', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.334', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}], 'classes': [{'title': 'Any Hypoglycemia Event: All Hypoglycemia', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}, {'value': '94.9', 'groupId': 'OG001'}]}]}, {'title': 'Severe Hypoglycemia: All Hypoglycemia', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Documented Symptomatic: All Hypoglycemia', 'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}]}]}, {'title': 'Asymptomatic: All Hypoglycemia', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}, {'value': '81.5', 'groupId': 'OG001'}]}]}, {'title': 'Probable Symptomatic: All Hypoglycemia', 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'Relative: All Hypoglycemia', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or Confirmed: All Hypoglycemia', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000'}, {'value': '94.5', 'groupId': 'OG001'}]}]}, {'title': 'Any Hypoglycemia Event: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000'}, {'value': '74.9', 'groupId': 'OG001'}]}]}, {'title': 'Severe Hypoglycemia: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Documented Symptomatic: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}, {'value': '63.3', 'groupId': 'OG001'}]}]}, {'title': 'Asymptomatic: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}]}]}, {'title': 'Probable Symptomatic: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Relative: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or Confirmed: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000'}, {'value': '74.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 12', 'description': 'Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \\<=3.9 mmol/L \\[70 mg/dL\\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \\<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \\<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \\>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \\<=3.9 mmol/L).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 (new insulin glargine 300 units per milliliter \\[U/mL\\]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.'}, {'id': 'FG001', 'title': 'Lantus', 'description': 'Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '275'}]}, {'type': 'Modified Intent-to-Treat Population', 'achievements': [{'comment': 'Participants who received at least 1 dose of drug, had both baseline, at least 1 post-baseline data', 'groupId': 'FG000', 'numSubjects': '273'}, {'comment': 'Participants who received at least 1 dose of drug, had both baseline, at least 1 post-baseline data', 'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Personal Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Selection Criterion / Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Site Closure / Site Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Nonserious Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Perceived Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Possibly Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Serious Adverse Event of Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 846 participants were screened, of whom 297 participants were screen failure and 549 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HOE901--U300', 'description': 'HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'BG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '48.2', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '47.3', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '27.6', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '27.6', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '21.4', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '21.0', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants analyzed for this baseline characteristics = 274 and 272 for each reporting group, respectively.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycated Hemoglobin (HbA1c)', 'classes': [{'title': 'Less Than (<) 8%', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}, {'title': 'Greater Than or Equal to (>=) 8%', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Basal Insulin Daily Dose', 'classes': [{'categories': [{'measurements': [{'value': '0.381', 'spread': '0.173', 'groupId': 'BG000'}, {'value': '0.372', 'spread': '0.152', 'groupId': 'BG001'}, {'value': '0.376', 'spread': '0.162', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants analyzed for this baseline characteristics = 201 and 210 for each reporting group, respectively.', 'unitOfMeasure': 'units per kilogram (U/kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Insulin Daily Dose', 'classes': [{'categories': [{'measurements': [{'value': '0.714', 'spread': '0.278', 'groupId': 'BG000'}, {'value': '0.724', 'spread': '0.245', 'groupId': 'BG001'}, {'value': '0.719', 'spread': '0.262', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants analyzed for this baseline characteristics = 195 and 198 for each reporting group, respectively.', 'unitOfMeasure': 'U/kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Randomized population: all screened participants (who originally met inclusion criteria and signed informed consent) allocated to a treatment group and recorded in Interactive Voice/Web Response System (IVRS/IWRS) database, regardless of whether treatment was used or not. Participants were analyzed in treatment group to which they were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 549}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2014-11-14', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2012-09-07', 'dispFirstSubmitQcDate': '2014-11-14', 'resultsFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2012-09-10', 'dispFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-22', 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change In HbA1c From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HbA1c <7% at Month 6 Endpoint', 'timeFrame': 'Month 6'}, {'measure': 'Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint', 'timeFrame': 'Month 6'}, {'measure': 'Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6', 'description': 'Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.'}, {'measure': 'Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6', 'description': 'Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.'}, {'measure': 'Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6', 'timeFrame': 'Month 6'}, {'measure': 'Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint', 'timeFrame': 'Month 6'}, {'measure': 'Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6', 'description': 'Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.'}, {'measure': 'Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6', 'description': 'DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.'}, {'measure': 'Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12', 'timeFrame': 'Up to Month 12', 'description': 'Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \\<=3.9 mmol/L \\[70 mg/dL\\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \\<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \\<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \\>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \\<=3.9 mmol/L).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28661585', 'type': 'DERIVED', 'citation': 'Home PD, Bergenstal RM, Bolli GB, Ziemen M, Rojeski M, Espinasse M, Riddle MC. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab. 2018 Jan;20(1):121-128. doi: 10.1111/dom.13048. Epub 2017 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n* To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus\n\nSecondary Objective:\n\n* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:\n* Change of HbA1c from baseline to endpoint (scheduled Month 6)\n* Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)\n* Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)\n* Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)\n* Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period', 'detailedDescription': 'The maximum study duration was up to approximately 54 weeks per participants:\n\n* Up to 2-week screening period\n* 6-month open-label comparative efficacy and safety treatment period\n* 6-month open-label comparative safety extension period\n* 48-hour post-treatment safety follow-up period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Adult participants with type 1 diabetes mellitus\n\nExclusion criteria:\n\n* HbA1c less than (\\<) 7.0% (53 mmol/mol) or greater than (\\>) 10% (86 mmol/mol) at screening\n* Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit\n* Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit\n* Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit\n* Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months\n* Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;\n* Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit\n* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01683266', 'acronym': 'EDITION IV', 'briefTitle': 'Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period', 'orgStudyIdInfo': {'id': 'EFC12456'}, 'secondaryIdInfos': [{'id': '2012-001524-35', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1128-5517', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HOE901-U300', 'description': 'HOE901-U300 (new insulin glargine 300 units per milliliter \\[U/mL\\]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \\[mg/dL\\]).', 'interventionNames': ['Drug: HOE901-U300 (Insulin glargine new formulation)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lantus', 'description': 'Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).', 'interventionNames': ['Drug: Lantus (Insulin glargine)']}], 'interventions': [{'name': 'HOE901-U300 (Insulin glargine new formulation)', 'type': 'DRUG', 'armGroupLabels': ['HOE901-U300']}, {'name': 'Lantus (Insulin glargine)', 'type': 'DRUG', 'armGroupLabels': ['Lantus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840156', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840177', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90201', 'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840430', 'geoPoint': {'lat': 33.96529, 'lon': -118.15146}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840131', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840140', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840107', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840149', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840120', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840123', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840159', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840114', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840189', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840105', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840155', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840115', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840160', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840188', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Investigational Site Number 840196', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840113', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840102', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840134', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840185', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32258', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840116', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840126', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840179', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840117', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840174', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840110', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840178', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840181', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840420', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840195', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Investigational Site Number 840124', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Investigational Site Number 840167', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'Investigational Site Number 840163', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840162', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 840172', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 840197', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840108', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840407', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site Number 840170', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840421', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 840426', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840104', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840180', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '1830', 'city': 'Haverhill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 840137', 'geoPoint': {'lat': 42.7762, 'lon': -71.07728}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840408', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48071', 'city': 'Madison Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840153', 'geoPoint': {'lat': 42.48587, 'lon': -83.1052}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site Number 840171', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 840184', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 840106', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 840145', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site Number 840139', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Investigational Site Number 840151', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 840191', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 840173', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840133', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840175', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28655', 'city': 'Morganton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840161', 'geoPoint': {'lat': 35.74541, 'lon': -81.68482}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 840169', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 840119', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site Number 840112', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840136', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '57049', 'city': 'Dakota Dunes', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Investigational Site Number 840122', 'geoPoint': {'lat': 42.48749, 'lon': -96.48642}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 840144', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 840187', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840109', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840157', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840150', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840412', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840130', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77095', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840141', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 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