Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT03211858
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2017-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Trial Transparency Team'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) weeks were collected from signature of the informed consent form up to the study completion (up to 52 Weeks) regardless of seriousness or relationship to investigational product.', 'description': "Reported AEs and deaths are treatment-emergent AEs, that is AEs that developed/worsened or became serious and deaths that occurred during the '12-month on-treatment period' (time from the first injection of IMP up to 1 day after the last injection of IMP). Analysis was performed on safety population.", 'eventGroups': [{'id': 'EG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.', 'otherNumAtRisk': 301, 'deathsNumAtRisk': 301, 'otherNumAffected': 70, 'seriousNumAtRisk': 301, 'deathsNumAffected': 1, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.', 'otherNumAtRisk': 296, 'deathsNumAtRisk': 296, 'otherNumAffected': 66, 'seriousNumAtRisk': 296, 'deathsNumAffected': 2, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 39, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Inappropriate Antidiuretic Hormone Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peptic Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Small Intestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Biliary Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Clostridium Difficile Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetic Foot Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Osteomyelitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device Use Error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ulna Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vascular Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rotator Cuff Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colon Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pancreatic Carcinoma Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Prolymphocytic Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Squamous Cell Carcinoma Of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycaemic Unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoglycaemic Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoglycaemic Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoglycaemic Unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Loss Of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intercapillary Glomerulosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tubulointerstitial Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumothorax Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetic Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.041', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.192', 'ciUpperLimit': '0.039', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.059', 'estimateComment': 'SAR341402 vs NovoLog/NovoRapid', 'groupDescription': 'Analysis was performed using ANCOVA with treatment group (SAR341402, NovoLog/NovoRapid), the randomization strata of geographical region, type of diabetes and prior use of NovoLog/NovoRapid as fixed categorical effects, as well as the continuous fixed covariate of baseline HbA1c value.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of SAR341402 over NovoLog/NovoRapid was demonstrated if upper bound of the 2-sided 95% confidence interval (CI) of the difference between SAR341402 and NovoLog/NovoRapid was \\<0.3%. If non-inferiority was demonstrated, using a hierarchical step down testing procedure, the inverse non-inferiority of NovoLog/NovoRapid over SAR341402 was tested and was demonstrated if lower bound of the 2-sided 95% CI of the difference between SAR341402 and NovoLog/NovoRapid was \\> -0.3%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': "All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae).", 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants, irrespective of compliance with the study protocol and procedures.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.059', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "All values up to Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 52 value. Missing changes at Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae).", 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c <7% at Week 26 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'At Week 26', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'At Week 52', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26 and Week 52', 'description': 'Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'At Week 26', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.249', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.245', 'groupId': 'OG001'}]}]}, {'title': 'At Week 52', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.366', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.359', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26, and Week 52', 'description': "All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in FPG at Week 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).", 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population.'}, {'type': 'SECONDARY', 'title': 'Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'At Week 26', 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.121', 'groupId': 'OG001'}]}]}, {'title': 'At Week 52', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.147', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26, and Week 52', 'description': "Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in mean 24-hour plasma glucose concentration at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population. Here, "Overall number of participants analyzed" = participants with a baseline mean 24-hour plasma glucose concentration.'}, {'type': 'SECONDARY', 'title': 'Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: At Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.232', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.233', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: At Lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.230', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.228', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: At Dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.243', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.243', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: At Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.253', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.255', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: At Lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.252', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.251', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: At Dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.255', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.254', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26, and Week 52', 'description': "Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as the average across profiles performed in the week before the visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in PPG excursions at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population. Here, "Number analyzed" = participants with a baseline value for each specified category.'}, {'type': 'SECONDARY', 'title': 'Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: Before Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.62', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '3.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: 2 Hours After Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Before Lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '4.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: 2 Hours After Lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.61', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '4.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Before Dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: 2 Hours After Dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '4.71', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '4.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Before Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '4.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: 2 Hours After Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '4.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Before Lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '4.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: 2 Hours After Lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '5.01', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '4.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Before Dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '4.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: 2 Hours After Dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '4.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '4.98', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '4.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, and Week 52', 'description': '7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 26, and Week 52): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population. Here, "Number analyzed" = participants with an available value at baseline, Week 26/Week 52 for the specified 7-point SMPG time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Hypoglycemic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: Any hypoglycemia', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Severe hypoglycemia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Documented symptomatic <=3.9 mmol/L', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Documented symptomatic < 3.0 mmol/L', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Any hypoglycemia', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Severe hypoglycemia', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Documented symptomatic <=3.9 mmol/L', 'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Documented symptomatic hypo < 3.0 mmol/L', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (\\<=70 mg/dL) or plasma glucose level of \\<3.0 mmol/L (\\<54 mg/dL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population that included all randomized participants who received at least one dose of IMP, analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycemia Events Per Participant-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: Any hypo', 'categories': [{'measurements': [{'value': '73.33', 'groupId': 'OG000'}, {'value': '69.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Severe hypo', 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000'}, {'value': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 26:Documented symptomatic hypo (<=3.9 mmol/L)', 'categories': [{'measurements': [{'value': '40.36', 'groupId': 'OG000'}, {'value': '36.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Documented symptomatic hypo (<3.0 mmol/L)', 'categories': [{'measurements': [{'value': '11.18', 'groupId': 'OG000'}, {'value': '9.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Any hypo', 'categories': [{'measurements': [{'value': '66.00', 'groupId': 'OG000'}, {'value': '64.46', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Severe hypo', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000'}, {'value': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 52:Documented symptomatic hypo (<=3.9 mmol/L)', 'categories': [{'measurements': [{'value': '35.68', 'groupId': 'OG000'}, {'value': '33.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Documented symptomatic hypo (<3.0 mmol/L)', 'categories': [{'measurements': [{'value': '9.37', 'groupId': 'OG000'}, {'value': '8.91', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Number of hypoglycemia events (any, severe and documented \\[both thresholds\\]) per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (\\<=70 mg/dL) or plasma glucose level of \\<3.0 mmol/L (\\<54 mg/dL).', 'unitOfMeasure': 'events per participant-year', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: Hypersensitivity Reactions', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Injection site reactions', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Hypersensitivity Reactions', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Injection site reactions', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Participants with at least one treatment-emergent adverse event linked to hypersensitivity reaction and injection site reaction regardless of relationship to IMP during the main 6-month and the 12-month on-treatment periods was assessed and reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'At Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}]}]}, {'title': 'At Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '58.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on AIA population, which included all participants who received at least one dose of IMP and had at least one AIA sample available for analysis during the on-treatment period, analyzed according to the treatment actually received. Here, "Number analyzed" = participants included in the AIA population at Week 26 and Week 52.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: Treatment-Induced AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '28.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Treatment-Boosted AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Treatment-Emergent AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Treatment-Induced AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000'}, {'value': '37.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Treatment-Boosted AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Treatment-Emergent AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000'}, {'value': '29.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). 2) Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on AIA population. Here, 'Number analyzed' = participants included in the AIA population at Week 26 and Week 52 and with negative or missing AIA status at baseline (for treatment-induced AIA) or with positive AIA status at baseline (for treatment-boosted AIA)."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Glycated Hemoglobin A1c From Baseline to Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior NovoLog/NovoRapid Use: SAR341402', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG002', 'title': 'Prior Humalog/Liprolog Use: SAR341402', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG003', 'title': 'Prior Humalog/Liprolog Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'At Week 26', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.052', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '0.070', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '0.067', 'groupId': 'OG003'}]}]}, {'title': 'At Week 52', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.069', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.091', 'groupId': 'OG002'}, {'value': '-0.26', 'spread': '0.087', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26 and Week 52', 'description': "All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c at Week 26 and Week 52 was calculated by subtracting baseline value from Week 26 and Week 52 value, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae).", 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population and data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With at Least One Hypoglycemic Event: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior NovoLog/NovoRapid Use: SAR341402', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG002', 'title': 'Prior Humalog/Liprolog Use: SAR341402', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG003', 'title': 'Prior Humalog/Liprolog Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: Any hypoglycemia', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}]}, {'title': 'Week 26: Severe hypoglycemia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Week 26: Documented symptomatic <=3.9 mmol/L', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}]}, {'title': 'Week 26: Documented symptomatic < 3.0 mmol/L', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: Any hypoglycemia', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: Severe hypoglycemia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: Documented symptomatic <=3.9 mmol/L', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: Documented symptomatic < 3.0 mmol/L', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (\\<=70 mg/dL) or plasma glucose level of \\<3.0 mmol/L (\\<54 mg/dL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population and data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior NovoLog/NovoRapid Use: SAR341402', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG002', 'title': 'Prior Humalog/Liprolog Use: SAR341402', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG003', 'title': 'Prior Humalog/Liprolog Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: Any TEAE', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: Any TEAE', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during the main 6-month or 12-month on-treatment periods.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population and data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs): Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior NovoLog/NovoRapid Use: SAR341402', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG002', 'title': 'Prior Humalog/Liprolog Use: SAR341402', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG003', 'title': 'Prior Humalog/Liprolog Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Week 26: Treatment-Induced AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}, {'value': '28.3', 'groupId': 'OG001'}, {'value': '29.9', 'groupId': 'OG002'}, {'value': '28.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 26: Treatment-Boosted AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}, {'value': '6.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 26: Treatment-Emergent AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '24.8', 'groupId': 'OG002'}, {'value': '21.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: Treatment-Induced AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}, {'value': '38.0', 'groupId': 'OG002'}, {'value': '41.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: Treatment-Boosted AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}, {'value': '9.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: Treatment-Emergent AIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}, {'value': '32.7', 'groupId': 'OG002'}, {'value': '31.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample. 2) Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. Data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on AIA population. Here, 'Number analyzed' = participants included in the AIA population at Week 26 and Week 52 and with negative or missing AIA status at baseline (for treatment-induced AIA) or with positive AIA status at baseline (for treatment-boosted AIA)."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Basal insulin dose at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '-0.000', 'spread': '0.023', 'groupId': 'OG001'}]}]}, {'title': 'Mealtime insulin dose at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.091', 'groupId': 'OG001'}]}]}, {'title': 'Total insulin dose at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.090', 'groupId': 'OG001'}]}]}, {'title': 'Basal insulin dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.088', 'groupId': 'OG001'}]}]}, {'title': 'Mealtime insulin dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.011', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.116', 'groupId': 'OG001'}]}]}, {'title': 'Total insulin dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.167', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.170', 'groupId': 'OG001'}]}]}, {'title': 'Basal insulin dose at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.095', 'groupId': 'OG001'}]}]}, {'title': 'Mealtime insulin dose at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Total insulin dose at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.175', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.165', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, Week 26 and Week 52', 'description': 'Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit.', 'unitOfMeasure': 'Units/kilogram (U/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'POST_HOC', 'title': 'Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior NovoLog/NovoRapid Use: SAR341402', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG001', 'title': 'Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG002', 'title': 'Prior Humalog/Liprolog Use: SAR341402', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'OG003', 'title': 'Prior Humalog/Liprolog Use: NovoLog/NovoRapid', 'description': 'Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}], 'classes': [{'title': 'Basal insulin dose at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.0000', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '-0.002', 'spread': '0.033', 'groupId': 'OG002'}, {'value': '-0.002', 'spread': '0.026', 'groupId': 'OG003'}]}]}, {'title': 'Mealtime insulin dose at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.071', 'groupId': 'OG001'}, {'value': '0.008', 'spread': '0.075', 'groupId': 'OG002'}, {'value': '0.013', 'spread': '0.118', 'groupId': 'OG003'}]}]}, {'title': 'Total insulin dose at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.075', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.077', 'groupId': 'OG001'}, {'value': '0.006', 'spread': '0.079', 'groupId': 'OG002'}, {'value': '0.011', 'spread': '0.111', 'groupId': 'OG003'}]}]}, {'title': 'Basal insulin dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.065', 'groupId': 'OG001'}, {'value': '0.008', 'spread': '0.070', 'groupId': 'OG002'}, {'value': '-0.006', 'spread': '0.118', 'groupId': 'OG003'}]}]}, {'title': 'Mealtime insulin dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.009', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '0.019', 'spread': '0.114', 'groupId': 'OG001'}, {'value': '-0.015', 'spread': '0.133', 'groupId': 'OG002'}, {'value': '-0.003', 'spread': '0.121', 'groupId': 'OG003'}]}]}, {'title': 'Total insulin dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.171', 'groupId': 'OG000'}, {'value': '0.027', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '-0.008', 'spread': '0.159', 'groupId': 'OG002'}, {'value': '-0.006', 'spread': '0.210', 'groupId': 'OG003'}]}]}, {'title': 'Basal insulin dose at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '0.010', 'spread': '0.067', 'groupId': 'OG002'}, {'value': '-0.009', 'spread': '0.105', 'groupId': 'OG003'}]}]}, {'title': 'Mealtime insulin dose at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.132', 'groupId': 'OG001'}, {'value': '-0.001', 'spread': '0.147', 'groupId': 'OG002'}, {'value': '-0.001', 'spread': '0.105', 'groupId': 'OG003'}]}]}, {'title': 'Total insulin dose at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.177', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.169', 'groupId': 'OG001'}, {'value': '0.009', 'spread': '0.171', 'groupId': 'OG002'}, {'value': '-0.009', 'spread': '0.156', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, Week 26, Week 52', 'description': 'Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day 1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit.', 'unitOfMeasure': 'U/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population and data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog). Here, 'Number analyzed' = participants with available data for each specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SAR341402', 'description': 'SAR341402 100 units per milliliter (U/mL) subcutaneous (SC) injection, before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.'}, {'id': 'FG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine,up to Week 52.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '296'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '296'}]}, {'type': 'COMPLETED', 'comment': 'Completed 12-month on treatment period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '263'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-serious Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'The study was conducted at 82 centers in 7 countries. A total of 846 participants were screened between 02 August 2017 and 29 December 2017, of which 249 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level lesser than (\\<) 7.0% or greater than (\\>) 10% at the screening visit.', 'preAssignmentDetails': 'Randomization was stratified by HbA1c at screening visit (\\<8%, greater than or equal to \\[\\>=\\] 8%), prior use of NovoLog/NovoRapid (Yes, No), geographical region (Europe, United States \\[US\\], Japan) and type 1 or 2 of diabetes mellitus (T1DM/T2DM \\[US only\\]). Assigned to arms in 1:1 ratio (SAR341402: NovoLog/NovoRapid).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SAR341402', 'description': 'SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'BG001', 'title': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.4', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '15.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '593', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '490', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Here, "Overall number of participants analyzed" = participants evaluable for this baseline measure.'}, {'title': 'Baseline Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.45', 'spread': '4.58', 'groupId': 'BG000'}, {'value': '27.46', 'spread': '4.99', 'groupId': 'BG001'}, {'value': '27.45', 'spread': '4.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram/meter square^2 (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '19.4', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '19.5', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycated Haemoglobin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.00', 'spread': '0.77', 'groupId': 'BG000'}, {'value': '7.94', 'spread': '0.70', 'groupId': 'BG001'}, {'value': '7.97', 'spread': '0.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Randomization Strata of Types of Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Type 1 Diabetes Mellitus', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '497', 'groupId': 'BG002'}]}, {'title': 'Type 2 Diabetes Mellitus', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Randomization Strata of Screening HbA1c Categories', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'title': 'HbA1c <8%', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}, {'title': 'HbA1c >=8%', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Randomization Strata of Prior Use of NovoLog/NovoRapid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No (Humalog/Liprolog)', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Yes (NovoLog/NovoRapid)', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '380', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, "No" signifies participant who had prior use of Humalog/Liprolog; "Yes" signifies prior use of NovoLog/NovoRapid.', 'unitOfMeasure': 'Participants'}, {'title': 'Randomization strata of geographical region', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Europe', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'Japan', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'US', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '335', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-13', 'size': 1086182, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-16T06:18', 'hasProtocol': True}, {'date': '2018-02-28', 'size': 785431, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-16T06:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 597}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2017-07-06', 'resultsFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-16', 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Glycated Hemoglobin A1c From Baseline to Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'timeFrame': 'Baseline, Week 26 and Week 52', 'description': "All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c at Week 26 and Week 52 was calculated by subtracting baseline value from Week 26 and Week 52 value, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae)."}, {'measure': 'Number of Participants With at Least One Hypoglycemic Event: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (\\<=70 mg/dL) or plasma glucose level of \\<3.0 mmol/L (\\<54 mg/dL).'}, {'measure': 'Number of Participants With Adverse Events: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during the main 6-month or 12-month on-treatment periods.'}, {'measure': 'Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs): Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample. 2) Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. Data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog).'}, {'measure': 'Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52', 'timeFrame': 'Baseline, Day 1, Week 26 and Week 52', 'description': 'Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit.'}], 'primaryOutcomes': [{'measure': 'Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae)."}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c From Baseline to Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "All values up to Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 52 value. Missing changes at Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae)."}, {'measure': 'Percentage of Participants With HbA1c <7% at Week 26 and Week 52', 'timeFrame': 'Week 26 and Week 52', 'description': 'Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52', 'timeFrame': 'Baseline, Week 26, and Week 52', 'description': "All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in FPG at Week 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae)."}, {'measure': 'Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52', 'timeFrame': 'Baseline, Week 26, and Week 52', 'description': "Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in mean 24-hour plasma glucose concentration at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae)."}, {'measure': 'Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52', 'timeFrame': 'Baseline, Week 26, and Week 52', 'description': "Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as the average across profiles performed in the week before the visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in PPG excursions at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae)."}, {'measure': 'Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point', 'timeFrame': 'Baseline, Week 26, and Week 52', 'description': '7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 26, and Week 52): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.'}, {'measure': 'Number of Participants With at Least One Hypoglycemic Event', 'timeFrame': 'From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (\\<=70 mg/dL) or plasma glucose level of \\<3.0 mmol/L (\\<54 mg/dL).'}, {'measure': 'Number of Hypoglycemia Events Per Participant-Year', 'timeFrame': 'From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Number of hypoglycemia events (any, severe and documented \\[both thresholds\\]) per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (\\<=70 mg/dL) or plasma glucose level of \\<3.0 mmol/L (\\<54 mg/dL).'}, {'measure': 'Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Participants with at least one treatment-emergent adverse event linked to hypersensitivity reaction and injection site reaction regardless of relationship to IMP during the main 6-month and the 12-month on-treatment periods was assessed and reported.'}, {'measure': 'Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence).'}, {'measure': 'Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)', 'timeFrame': 'From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52', 'description': 'AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). 2) Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31804851', 'type': 'BACKGROUND', 'citation': 'Garg SK, Wernicke-Panten K, Wardecki M, Kramer D, Delalande F, Franek E, Sadeharju K, Monchamp T, Mukherjee B, Shah VN. Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1). Diabetes Technol Ther. 2020 Feb;22(2):85-95. doi: 10.1089/dia.2019.0382.'}, {'pmid': '32068436', 'type': 'BACKGROUND', 'citation': 'Garg SK, Wernicke-Panten K, Wardecki M, Kramer D, Delalande F, Franek E, Sadeharju K, Monchamp T, Miossec P, Mukherjee B, Shah VN. Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial. Diabetes Technol Ther. 2020 Jul;22(7):516-526. doi: 10.1089/dia.2020.0008. Epub 2020 Mar 31.'}, {'pmid': '33432547', 'type': 'DERIVED', 'citation': 'Shah VN, Franek E, Wernicke-Panten K, Pierre S, Mukherjee B, Sadeharju K. Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin. Diabetes Ther. 2021 Feb;12(2):557-568. doi: 10.1007/s13300-020-00992-x. Epub 2021 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®.\n\nSecondary Objectives:\n\n* To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study.\n* To assess the relationship of AIAs with efficacy and safety.\n* To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of participants reaching HbA1c lesser than (\\<) 7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c).\n* To assess safety of SAR341402 and NovoLog/NovoRapid.', 'detailedDescription': 'The study consisted of a 2-week screening period, a 26-week treatment period, a 26-week comparative safety extension period, and a 1-day follow-up period. The maximum study duration was 54 weeks per participant and a 1 day safety follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with\n* NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening visit AND\n* insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin detemir (Levemir®) in the last 12 months prior to screening visit.\n\nExclusion criteria:\n\n* At screening visit, age under legal age of adulthood.\n* HbA1c \\<7.0% or greater than (\\>) 10% at screening.\n* Less than 1 year on continuous insulin treatment.\n* Use of insulin pump in the last 3 months before screening visit.\n* Participants with incomplete baseline 7-point SMPG profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3.\n* Participants with T1DM: Use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening.\n* Participants with T2DM:\n\n * Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months before screening visit.\n * Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months before screening visit (sulfonylureas was discontinued at baseline).\n* At screening visit, body mass index (BMI) greater than or equal to (\\>=) 35 kilogram per meter square (kg/m\\^2) in participants with T1DM and \\>=40 kg/m\\^2 in participants with T2DM.\n* Use of insulin other than:\n\n * insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as part of a multiple injection regimen in the last 6 months before screening visit, OR\n * insulin detemir 100 U/mL in the 12 months before screening visit and NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before screening visit as part of a multiple injection regimen.\n* Status post pancreatectomy.\n* Status post pancreas and/or islet cell transplantation.\n* Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before screening visit.\n* History of severe hypoglycemia requiring Emergency Room admission or hospitalization in the last 3 months before screening visit.\n* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.\n* Pregnant or breastfeeding women.\n* Women of childbearing potential not protected by highly effective method(s) of birth control.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03211858', 'acronym': 'GEMELLI1', 'briefTitle': 'Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period', 'orgStudyIdInfo': {'id': 'EFC15081'}, 'secondaryIdInfos': [{'id': '2017-000091-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1191-5775', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAR341402', 'description': 'SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.', 'interventionNames': ['Drug: Insulin aspart', 'Drug: Insulin glargine (HOE901)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NovoLog/NovoRapid', 'description': 'NovoLog/NovoRapid SC, before meals intake on top of QD Insulin Glargine, up to Week 52.', 'interventionNames': ['Drug: NovoLog/NovoRapid', 'Drug: Insulin glargine (HOE901)']}], 'interventions': [{'name': 'Insulin aspart', 'type': 'DRUG', 'description': 'SAR341402 100 units per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG \\<10 millimoles/liter \\[mmol/L\\] \\[\\<180 milligram/deciliter {mg/dL}\\]) while avoiding hypoglycemia.', 'armGroupLabels': ['SAR341402']}, {'name': 'NovoLog/NovoRapid', 'type': 'DRUG', 'otherNames': ['Insulin aspart'], 'description': 'NovoLog/NovoRapid 100 U/mL (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG \\<10 mmol/L \\[\\<180 mg/dL\\]) while avoiding hypoglycemia.', 'armGroupLabels': ['NovoLog/NovoRapid']}, {'name': 'Insulin glargine (HOE901)', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.', 'armGroupLabels': ['NovoLog/NovoRapid', 'SAR341402']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 8400040', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400012', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400002', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400030', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400004', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400014', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400043', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91766', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400036', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400011', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400013', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 8400037', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 8400018', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400031', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400027', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 8400007', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 8400022', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 8400032', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 8400038', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 8400005', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 8400041', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '20852-4267', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 8400015', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02453', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 8400042', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '48532-3447', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 8400019', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8400003', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site Number 8400024', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 8400028', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8400025', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8400010', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Investigational Site Number 8400023', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site Number 8400029', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 8400033', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400044', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400009', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400035', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400021', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77043', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400017', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400001', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77089', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400020', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400016', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '84102', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400034', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigational Site Number 8400008', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '26330', 'city': 'Bridgeport', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Investigational Site Number 8400039', 'geoPoint': {'lat': 39.28648, 'lon': -80.2562}}, {'zip': '40100', 'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Investigational Site Number 2460006', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '70100', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Investigational Site Number 2460002', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '28500', 'city': 'Pori', 'country': 'Finland', 'facility': 'Investigational Site Number 2460004', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '60100', 'city': 'Seinäjoki', 'country': 'Finland', 'facility': 'Investigational Site Number 2460003', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'zip': '10115', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site Number 2760001', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'Investigational Site Number 2760006', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '69115', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Investigational Site Number 2760004', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '23758', 'city': 'Oldenburg in Holstein', 'country': 'Germany', 'facility': 'Investigational Site Number 2760005', 'geoPoint': {'lat': 54.29498, 'lon': 10.89043}}, {'zip': '01796', 'city': 'Pirna', 'country': 'Germany', 'facility': 'Investigational Site Number 2760002', 'geoPoint': {'lat': 50.95843, 'lon': 13.93702}}, {'zip': '8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480012', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480011', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1042', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480008', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1062', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480001', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1062', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480005', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1139', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480004', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4031', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480007', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '8800', 'city': 'Nagykanizsa', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480003', 'geoPoint': {'lat': 46.45347, 'lon': 16.99104}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480010', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '2000', 'city': 'Szentendre', 'country': 'Hungary', 'facility': 'Investigational Site Number 3480009', 'geoPoint': {'lat': 47.66943, 'lon': 19.07561}}, {'city': 'Fukuyama-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 3920009'}, {'city': 'Higashiosaka-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 3920008'}, {'city': 'Kashiwara-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 3920007'}, {'city': 'Koriyama-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 3920001'}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Investigational Site Number 3920005', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Mito', 'country': 'Japan', 'facility': 'Investigational Site Number 3920003', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Investigational Site Number 3920010', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sagamihara-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 3920002'}, {'city': 'Shinjuku-Ku', 'country': 'Japan', 'facility': 'Investigational Site Number 3920004'}, {'city': 'Ushiku-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 3920006'}, {'zip': '15-435', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Investigational Site Number 6160004', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Investigational Site Number 6160003', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-548', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Investigational Site Number 6160005', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-538', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Investigational Site Number 6160007', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '33-300', 'city': 'Nowy Sącz', 'country': 'Poland', 'facility': 'Investigational Site Number 6160006', 'geoPoint': {'lat': 49.62177, 'lon': 20.69705}}, {'zip': '60-834', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Investigational Site Number 6160001', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Investigational Site Number 6160002', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '194358', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigational Site Number 6430001', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443041', 'city': 'Samara', 'country': 'Russia', 'facility': 'Investigational Site Number 6430002', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '410030', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Investigational Site Number 6430003', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '634050', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Investigational Site Number 6430004', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}