Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01676220
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2012-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
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'}], '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' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.", 'eventGroups': [{'id': 'EG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).', 'otherNumAtRisk': 435, 'otherNumAffected': 115, 'seriousNumAtRisk': 435, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).', 'otherNumAtRisk': 438, 'otherNumAffected': 107, 'seriousNumAtRisk': 438, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Pulmonary mycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Carotid artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Cerebral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Medical device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 17.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numAffected': 0}], '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': '402', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.42', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-1.46', 'spread': '0.048', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.090', 'ciUpperLimit': '0.174', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.067', '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', 'description': 'Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4536', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.20', 'groupDescription': 'A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (\\<8.0, \\>=8.0%), randomization strata of geographical region (Non-Japan; Japan).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 9 Up to Month 6', 'description': 'Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (\\<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \\[mg/dL\\]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.16', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '0.156', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.275', 'ciUpperLimit': '0.605', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.224', '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; baseline preinjection SMPG value and baseline preinjection 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. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)'}, {'type': 'SECONDARY', 'title': 'Variability of Preinjection SMPG at Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.70', 'spread': '0.502', 'groupId': 'OG000'}, {'value': '18.33', 'spread': '0.521', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '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. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.', 'unitOfMeasure': 'percentage of mean', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c <7% at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}, {'value': '42.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.41', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '-3.80', 'spread': '0.105', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).'}, {'type': 'SECONDARY', 'title': 'Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'title': '03:00 at Night Plasma Glucose (n=281,277)', 'categories': [{'measurements': [{'value': '-2.63', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '-3.01', 'spread': '3.75', 'groupId': 'OG001'}]}]}, {'title': 'Pre-Breakfast Plasma Glucose (n=292,286)', 'categories': [{'measurements': [{'value': '-3.28', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '-3.72', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Breakfast Plasma Glucose (n=278,278)', 'categories': [{'measurements': [{'value': '-3.69', 'spread': '3.65', 'groupId': 'OG000'}, {'value': '-4.08', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Pre-Lunch Plasma Glucose (n=289,281)', 'categories': [{'measurements': [{'value': '-2.58', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '-3.39', 'spread': '3.76', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Lunch Plasma Glucose (n=280,269)', 'categories': [{'measurements': [{'value': '-2.19', 'spread': '3.88', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '3.77', 'groupId': 'OG001'}]}]}, {'title': 'Pre-Dinner Plasma Glucose (n=291,285)', 'categories': [{'measurements': [{'value': '-2.57', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '-2.43', 'spread': '3.79', 'groupId': 'OG001'}]}]}, {'title': '2 Hours After Dinner Plasma Glucose (n=282,269)', 'categories': [{'measurements': [{'value': '-2.36', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime Plasma Glucose (n=249,249)', 'categories': [{'measurements': [{'value': '-2.19', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '-2.26', 'spread': '3.66', '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. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.72', 'spread': '0.088', 'groupId': 'OG000'}, {'value': '-2.90', 'spread': '0.089', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 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. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).'}, {'type': 'SECONDARY', 'title': 'Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.53', 'spread': '0.643', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.647', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.', 'unitOfMeasure': 'percentage of mean', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).'}, {'type': 'SECONDARY', 'title': 'Change in Daily Basal Insulin Dose From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.', 'unitOfMeasure': 'U/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal 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': '371', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.89', 'spread': '0.246', 'groupId': 'OG000'}, {'value': '5.12', 'spread': '0.251', '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. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'classes': [{'title': 'Any Hypoglycemia Event: All Hypoglycemia', 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000'}, {'value': '63.2', 'groupId': 'OG001'}]}]}, {'title': 'Severe Hypoglycemia: All Hypoglycemia', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Documented Symptomatic: All Hypoglycemia', 'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}]}]}, {'title': 'Asymptomatic: All Hypoglycemia', 'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}]}]}, {'title': 'Probable Symptomatic: All Hypoglycemia', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Relative: All Hypoglycemia', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or Confirmed: All Hypoglycemia', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '61.2', 'groupId': 'OG001'}]}]}, {'title': 'Any Hypoglycemia Event: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}, {'value': '30.1', 'groupId': 'OG001'}]}]}, {'title': 'Severe Hypoglycemia: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Documented Symptomatic: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'Asymptomatic: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'Probable Symptomatic: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Relative: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or Confirmed: Nocturnal Hypoglycemia', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', '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 (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'FG001', 'title': 'Lantus (Insulin Glargine)', 'description': 'Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}, {'groupId': 'FG001', 'numSubjects': '439'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '435'}, {'groupId': 'FG001', 'numSubjects': '438'}]}, {'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': '432'}, {'comment': 'Participants who received at least 1 dose of drug, had both baseline, at least 1 post-baseline data', 'groupId': 'FG001', 'numSubjects': '430'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '125'}]}], 'dropWithdraws': [{'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Received Rescue Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Personal Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Selection Criterion/Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Site Closure/Site Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Perceived Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non Serious Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No More Need of Insulin', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 1396 participants were screened, of whom 518 participants were screen failure and 878 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '878', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'BG001', 'title': 'Lantus', 'description': 'Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '33.2', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '10.11', 'spread': '6.49', 'groupId': 'BG000'}, {'value': '9.57', 'spread': '6.22', 'groupId': 'BG001'}, {'value': '9.84', 'spread': '6.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants analyzed for this baseline characteristics = 435 and 436 in HOE901-U300 and Lantus arm, respectively.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Basal Insulin Daily Dose', 'classes': [{'categories': [{'measurements': [{'value': '0.193', 'spread': '0.027', 'groupId': 'BG000'}, {'value': '0.193', 'spread': '0.034', 'groupId': 'BG001'}, {'value': '0.193', 'spread': '0.031', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants analyzed for this baseline characteristics = 432 and 436 in HOE901-U300 and Lantus arm, respectively.', 'unitOfMeasure': 'units per kilogram (U/kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycated Hemoglobin A1c (HbA1c)', 'classes': [{'title': 'Less Than (<) 8%', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}, {'title': 'Greater Than or Equal to (>=) 8%', 'categories': [{'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '595', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], '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': 878}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2014-11-14', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2012-08-28', 'dispFirstSubmitQcDate': '2014-11-14', 'resultsFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2012-08-28', 'dispFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-22', 'studyFirstPostDateStruct': {'date': '2012-08-30', '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', 'description': 'Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6', 'timeFrame': 'Week 9 Up to Month 6', 'description': 'Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (\\<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \\[mg/dL\\]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.'}, {'measure': 'Change in Preinjection Self-Monitored Plasma Glucose (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. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.'}, {'measure': 'Variability of Preinjection SMPG at Month 6 Endpoint', 'timeFrame': '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. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.'}, {'measure': 'Percentage of Participants With HbA1c <7% at Month 6', 'timeFrame': 'Month 6', 'description': 'Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6', 'description': 'Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.'}, {'measure': 'Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6', 'timeFrame': 'Month 6', 'description': 'Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.'}, {'measure': 'Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6', '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. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.'}, {'measure': 'Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6', 'description': 'Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 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. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.'}, {'measure': 'Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint', 'timeFrame': 'Baseline, Month 6', 'description': 'Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.'}, {'measure': 'Change in Daily Basal Insulin Dose From Baseline to Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.'}, {'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. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.'}, {'measure': 'Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12', 'timeFrame': 'Up to 12 months', '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 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25641260', 'type': 'RESULT', 'citation': 'Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, Home PD; on behalf of the EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015 Apr;17(4):386-94. doi: 10.1111/dom.12438. Epub 2015 Feb 12.'}, {'pmid': '30366067', 'type': 'DERIVED', 'citation': 'Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.'}, {'pmid': '30160030', 'type': 'DERIVED', 'citation': 'Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.'}, {'pmid': '29370218', 'type': 'DERIVED', 'citation': 'Yale JF, Pettus JH, Brito-Sanfiel M, Lavalle-Gonzalez F, Merino-Trigo A, Stella P, Chevalier S, Buzzetti R. The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PLoS One. 2018 Jan 25;13(1):e0190579. doi: 10.1371/journal.pone.0190579. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus\n\nSecondary Objectives:\n\nTo compare a new formulation of insulin glargine and Lantus in terms of:\n\n\\- occurrence of nocturnal hypoglycemia', 'detailedDescription': 'The maximum study duration was up to approximately 54 weeks per participant, consisting of:\n\n* Up to 2 week screening period; it can be exceptionally extended of up to one additional week\n* 6-month comparative efficacy and safety treatment period\n* 6-month comparative safety extension period\n* 2-day 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 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);\n* Signed written informed consent.\n\nExclusion criteria:\n\n* HbA1c less than (\\<) 7.0% (\\< 53 millimole per mole \\[mmol/mol\\]) or greater than (\\>) 11% (\\> 97 mmol/mol)\n* History of type 2 diabetes mellitus for less than 1 year before screening\n* Less than 6 months before screening with non-insulin antihyperglycemic treatment\n* Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening\n* Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit\n* Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)\n* Current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening\n* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for 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': 'NCT01676220', 'acronym': 'EDITION III', 'briefTitle': 'Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': '6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs With a 6-month Safety Extension Period', 'orgStudyIdInfo': {'id': 'EFC12347'}, 'secondaryIdInfos': [{'id': '2012-000146-35', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1124-5261', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HOE901-U300', 'interventionNames': ['Drug: HOE901-U300 (new formulation of insulin glargine)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lantus', 'interventionNames': ['Drug: Lantus (insulin glargine)']}], 'interventions': [{'name': 'HOE901-U300 (new formulation of insulin glargine)', 'type': 'DRUG', 'description': 'HOE901-U300 (new insulin glargine 300 units per milliliter \\[U/mL\\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \\[mg/dL\\]).', 'armGroupLabels': ['HOE901-U300']}, {'name': 'Lantus (insulin glargine)', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).', 'armGroupLabels': ['Lantus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36109', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840324', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840273', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840217', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85050', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840220', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840211', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840207', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840264', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840234', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840304', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90201', 'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840347', 'geoPoint': {'lat': 33.96529, 'lon': -118.15146}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840244', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840257', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840213', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840267', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840230', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840235', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840274', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840222', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840243', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840250', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840209', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840297', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840272', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840223', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840249', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80212', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 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{'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840266', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840204', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840248', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840226', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840318', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32258', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840224', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840228', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840238', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840302', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33141', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840337', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 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'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840332', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840288', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840325', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33716', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840309', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840251', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840339', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840245', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840323', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Investigational Site Number 840236', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Investigational Site Number 840283', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840278', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840320', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840276', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 840314', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 840317', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840214', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site Number 840232', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site Number 840287', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840344', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '42003', 'city': 'Murray', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840231', 'geoPoint': {'lat': 36.61033, 'lon': -88.31476}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 840348', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 840290', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840208', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840301', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 840289', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '1830', 'city': 'Haverhill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 840253', 'geoPoint': {'lat': 42.7762, 'lon': -71.07728}}, {'zip': '48071', 'city': 'Madison Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840270', 'geoPoint': {'lat': 42.48587, 'lon': -83.1052}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 840300', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 840210', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 840263', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89117', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site Number 840349', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site Number 840201', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las 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840307', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 840229', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site Number 840219', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 840240', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '16684', 'city': 'Tipton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 840308', 'geoPoint': {'lat': 40.6359, 'lon': -78.29585}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840252', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, 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