Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 1:30 PM
Study NCT ID:
NCT01768559
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2013-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479460', 'term': 'lixisenatide'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 185) regardless of seriousness or relationship to IMP.', 'description': "Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose of study drug up to 3 days after the last dose of study drug). Analysis was done on safety population.\n\n4 participants randomized to TID group, but received insulin glulisine QD were analyzed according to the QD dose. 1 participant randomized to QD group, but received insulin glulisine TID was analyzed according to the TID dose.", 'eventGroups': [{'id': 'EG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin (Median exposure of 182 days).', 'otherNumAtRisk': 298, 'otherNumAffected': 183, 'seriousNumAtRisk': 298, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).', 'otherNumAtRisk': 301, 'otherNumAffected': 186, 'seriousNumAtRisk': 301, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).', 'otherNumAtRisk': 294, 'otherNumAffected': 195, 'seriousNumAtRisk': 294, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 154}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 82}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Penile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Septic arthritis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neuritis cranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetic bullosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Skin ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.054', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.053', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.064', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.059', 'estimateComment': 'Lixisenatide vs Insulin Glulisine QD', 'groupDescription': 'Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, strata of Week -1 HbA1c (\\<8.0, ≥8.0%), randomization strata of metformin use, and country as fixed effects and baseline HbA1c value as a covariate. The non-inferiority was assessed using upper bound of 2-sided 95% Confidence Interval (CI).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Pre-specified non-inferiority margin of 0.4%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.095', 'ciUpperLimit': '0.328', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.059', 'estimateComment': 'Lixisenatide vs Insulin Glulisine TID', 'groupDescription': 'Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at significance level = 0.025 (1-sided) for comparison between Lixisenatide vs Insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Pre-specified non-inferiority margin of 0.4%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.'}, {'type': 'PRIMARY', 'title': 'Change in Body Weight From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.276', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '0.276', 'groupId': 'OG001'}, {'value': '1.37', 'spread': '0.271', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.99', 'ciLowerLimit': '-2.593', 'ciUpperLimit': '-1.396', 'pValueComment': 'Threshold for significance at 0.025 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.305', 'estimateComment': 'Lixisenatide vs Insulin Glulisine TID', 'groupDescription': 'Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at α = 0.025 (1-sided) for comparison between lixisenatide vs insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The superiority was assessed by comparing the P-value at significance level = 0.025 or 0.0125.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.\n\nChange in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'title': 'HbA1c ≤6.5%', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}, {'value': '30.8', 'groupId': 'OG002'}]}]}, {'title': 'HbA1c <7.0%', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '38.4', 'groupId': 'OG001'}, {'value': '49.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Weight Gain at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000'}, {'value': '36.6', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in Average 7-point SMPG Profiles From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.784', 'spread': '0.1141', 'groupId': 'OG000'}, {'value': '-0.782', 'spread': '0.1133', 'groupId': 'OG001'}, {'value': '-1.053', 'spread': '0.1105', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in FPG From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.14', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.93', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '4.01', 'groupId': 'OG001'}, {'value': '-1.87', 'spread': '3.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.42', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '2.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline glucose excursion assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Glargine Dose From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.002', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.999', 'groupId': 'OG001'}, {'value': '-3.13', 'spread': '0.982', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.', 'unitOfMeasure': 'U', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glargine dose assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Insulin Glulisine Dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.97', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '20.24', 'spread': '13.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.', 'unitOfMeasure': 'U', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glulisine dose assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Total Insulin Dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.61', 'spread': '39.13', 'groupId': 'OG000'}, {'value': '81.05', 'spread': '33.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.\n\nThe outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9.', 'unitOfMeasure': 'U', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline total insulin dose assessment during on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'title': 'Documented symptomatic hypoglycemia', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '44.6', 'groupId': 'OG002'}]}]}, {'title': 'Severe symptomatic hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were exposed to at least one dose of study drug, regardless of the amount of treatment administered.\n\nThe 4 participants in the TID group who received Insulin Glulisine QD were analyzed according to the QD dose.The 1 participant in the QD group who received Insulin Glulisine TID was analyzed according to the TID dose'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}, {'value': '26.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response. Otherwise, they were counted as missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}, {'value': '10.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.Participants without post-baseline on-treatment values(HbA1c;body weight),no more than 30 days apart counted as non-responders if at least one of components(HbA1c;body weight) was available,showed non-response or experienced at least one symptomatic hypoglycemia during on-treatment period.Otherwise,they were counted as missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg once daily (QD) subcutaneously (SC) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'FG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'FG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine thrice daily (TID) SC up to Week 26 on top of insulin glargine with or without metformin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '298'}, {'groupId': 'FG002', 'numSubjects': '298'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'comment': '1 participant received Insulin Glulisine TID (for more than 50%)', 'groupId': 'FG001', 'numSubjects': '298'}, {'comment': '4 participants received Insulin Glulisine QD (for more than 50%)', 'groupId': 'FG002', 'numSubjects': '297'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '281'}, {'groupId': 'FG002', 'numSubjects': '285'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The study was conducted at 199 centers in 18 countries. A total of 2159 participants were screened between January 08, 2013 and April 10, 2014.', 'preAssignmentDetails': 'Participants underwent a 12-week run-in period with switch from other basal insulins to insulin glargine. A total of 1265 participants were screen failures/run-in failures; the most frequent reason for run-in failure was that glycosylated hemoglobin (HbA1c) criteria were not met at the end of run-in phase. 894 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}, {'value': '894', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'BG001', 'title': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'BG002', 'title': 'Insulin Glulisine TID', 'description': 'Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '59.8', 'spread': '8.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '489', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '405', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'title': 'Caucasian/White', 'categories': [{'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}, {'value': '828', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Asian/Oriental', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}]}, {'title': 'Non-Hispanic', 'categories': [{'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '705', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Metformin Use at Screening', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}, {'value': '781', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Participants with Categorical Body Mass Index (BMI)', 'classes': [{'title': '<30 kg/m^2', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG003'}]}]}, {'title': '≥30 kg/m^2', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '581', 'groupId': 'BG003'}]}]}, {'title': 'Participants not analyzed for BMI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '32.27', 'spread': '4.57', 'groupId': 'BG000'}, {'value': '31.86', 'spread': '4.39', 'groupId': 'BG001'}, {'value': '32.50', 'spread': '4.60', 'groupId': 'BG002'}, {'value': '32.21', 'spread': '4.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for baseline BMI analysis.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '90.06', 'spread': '17.31', 'groupId': 'BG000'}, {'value': '88.45', 'spread': '15.84', 'groupId': 'BG001'}, {'value': '90.08', 'spread': '17.18', 'groupId': 'BG002'}, {'value': '89.53', 'spread': '16.79', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '893 participants (298 in Lixisenatide arm, 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for baseline weight analysis.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.77', 'spread': '0.55', 'groupId': 'BG000'}, {'value': '7.73', 'spread': '0.59', 'groupId': 'BG001'}, {'value': '7.79', 'spread': '0.60', 'groupId': 'BG002'}, {'value': '7.76', 'spread': '0.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for HbA1c analysis.', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '6.58', 'spread': '1.82', 'groupId': 'BG000'}, {'value': '6.84', 'spread': '1.98', 'groupId': 'BG001'}, {'value': '6.65', 'spread': '1.89', 'groupId': 'BG002'}, {'value': '6.69', 'spread': '1.90', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for FPG analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-Hour Postprandial Plasma Glucose (PPG)', 'classes': [{'categories': [{'measurements': [{'value': '14.26', 'spread': '3.55', 'groupId': 'BG000'}, {'value': '14.02', 'spread': '3.59', 'groupId': 'BG001'}, {'value': '14.25', 'spread': '3.35', 'groupId': 'BG002'}, {'value': '14.18', 'spread': '3.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '258 participants (79 in Lixisenatide arm; 77 in Insulin glulisine QD and 102 in Insulin glulisine TID) were included for PPG analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-Hour Glucose Excursion', 'classes': [{'categories': [{'measurements': [{'value': '7.31', 'spread': '3.19', 'groupId': 'BG000'}, {'value': '7.31', 'spread': '3.63', 'groupId': 'BG001'}, {'value': '7.35', 'spread': '3.34', 'groupId': 'BG002'}, {'value': '7.33', 'spread': '3.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '243 participants (73 in Lixisenatide arm, 74 in Insulin glulisine QD and 96 in Insulin glulisine TID) were included for 2-hour glucose excursion analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average 7-Point Self-monitored Plasma Glucose (SMPG)', 'classes': [{'categories': [{'measurements': [{'value': '9.02', 'spread': '1.75', 'groupId': 'BG000'}, {'value': '9.07', 'spread': '1.74', 'groupId': 'BG001'}, {'value': '8.99', 'spread': '1.57', 'groupId': 'BG002'}, {'value': '9.02', 'spread': '1.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '877 participants (292 in Lixisenatide arm; 291 in Insulin glulisine QD and 294 in Insulin glulisine TID) were included for average 7-point SMPG analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin Glargine Dose', 'classes': [{'categories': [{'measurements': [{'value': '67.25', 'spread': '31.95', 'groupId': 'BG000'}, {'value': '64.72', 'spread': '32.07', 'groupId': 'BG001'}, {'value': '64.97', 'spread': '26.90', 'groupId': 'BG002'}, {'value': '65.65', 'spread': '30.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for Insulin glargine dose analysis.', 'unitOfMeasure': 'Units (U)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '11.89', 'spread': '6.43', 'groupId': 'BG000'}, {'value': '12.33', 'spread': '6.75', 'groupId': 'BG001'}, {'value': '12.41', 'spread': '6.80', 'groupId': 'BG002'}, {'value': '12.21', 'spread': '6.66', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 894}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2015-12-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-04', 'studyFirstSubmitDate': '2013-01-11', 'dispFirstSubmitQcDate': '2015-12-02', 'resultsFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2013-01-11', 'dispFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-04', 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.'}, {'measure': 'Change in Body Weight From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.\n\nChange in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.'}, {'measure': 'Percentage of Participants With no Weight Gain at Week 26', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.'}, {'measure': 'Change in Average 7-point SMPG Profiles From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.'}, {'measure': 'Change in FPG From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.'}, {'measure': 'Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)', 'timeFrame': 'Baseline, Week 26', 'description': 'The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.'}, {'measure': 'Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)', 'timeFrame': 'Baseline, Week 26', 'description': 'Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.'}, {'measure': 'Change in Insulin Glargine Dose From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.'}, {'measure': 'Insulin Glulisine Dose at Week 26', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.'}, {'measure': 'Total Insulin Dose at Week 26', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.\n\nThe outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9.'}, {'measure': 'Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia', 'timeFrame': 'First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.'}, {'measure': 'Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.'}, {'measure': 'Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.'}, {'measure': 'Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period', 'timeFrame': 'Week 26', 'description': 'The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27222510', 'type': 'RESULT', 'citation': 'Rosenstock J, Guerci B, Hanefeld M, Gentile S, Aronson R, Tinahones FJ, Roy-Duval C, Souhami E, Wardecki M, Ye J, Perfetti R, Heller S; GetGoal Duo-2 Trial Investigators. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care. 2016 Aug;39(8):1318-28. doi: 10.2337/dc16-0014. Epub 2016 May 23.'}, {'pmid': '31848983', 'type': 'DERIVED', 'citation': 'Tabak AG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.'}, {'pmid': '29974618', 'type': 'DERIVED', 'citation': 'Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n\\- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.\n\nSecondary Objectives:\n\n\\- To compare the treatments/regimens on:\n\n* The percentage of participants reaching the target of HbA1c \\<7% or ≤6.5%,\n* Body weight,\n* Self-Monitored Glucose profiles,\n* Fasting Plasma Glucose (FPG),\n* Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),\n* Daily doses of insulins,\n* Safety and tolerability.', 'detailedDescription': 'Approximately 41 weeks including a 26 week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1).\n* Participants treated with basal insulin for at least 6 months.\n* Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1.\n* Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.\n\nExclusion criteria:\n\n* At screening: age \\< legal age of majority.\n* At screening, HbA1c: \\<7.5% and \\>10.0% for participants treated with basal insulin alone or in combination with metformin only; \\< 7.0% and \\> 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide.\n* Women of childbearing potential with no effective contraceptive method, pregnancy or lactation.\n* Type 1 diabetes mellitus.\n* Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.\n* Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.\n* Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.\n* At screening, Body Mass Index (BMI) ≤20 or \\>40 kg/m\\^2.\n* Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.\n* Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.\n* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.\n* At screening resting systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>95 mmHg.\n* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposed to MTC (e.g. multiple endocrine neoplasia syndromes).\n* Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.\n* Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.\n* At screening, amylase and/or lipase \\>3 times the upper limit of the normal laboratory range (ULN).\n* At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 ULN.\n* At screening calcitonin ≥20 pg/ml (5.9 pmol/L).\n\nExclusion Criteria for randomization at the end of the screening period before randomization:\n\n* HbA1c \\<7.0% or \\>9.0%.\n* 7-day mean fasting SMPG \\>140 mg/dl (7.8 mmol/L).\n* Amylase and/or lipase \\>3 times ULN.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01768559', 'acronym': 'GetGoal-Duo-2', 'briefTitle': 'Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin', 'orgStudyIdInfo': {'id': 'EFC12626'}, 'secondaryIdInfos': [{'id': '2012-004096-38', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1131-4936', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.', 'interventionNames': ['Drug: Lixisenatide (AVE0010)', 'Drug: Insulin Glargine (Mandatory background drug)', 'Drug: Metformin (Background drug)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glulisine QD', 'description': 'Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.', 'interventionNames': ['Drug: Insulin glulisine QD', 'Drug: Insulin Glargine (Mandatory background drug)', 'Drug: Metformin (Background drug)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glulisine TID', 'description': 'Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.', 'interventionNames': ['Drug: Insulin glulisine TID', 'Drug: Insulin Glargine (Mandatory background drug)', 'Drug: Metformin (Background drug)']}], 'interventions': [{'name': 'Lixisenatide (AVE0010)', 'type': 'DRUG', 'otherNames': ['Lyxumia®', 'Device: Disposable self-injector prefilled pen (Delta 14®)'], 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner.', 'armGroupLabels': ['Lixisenatide']}, {'name': 'Insulin glulisine QD', 'type': 'DRUG', 'otherNames': ['HMR1964', 'Device: Disposable self-injector prefilled pen (Apidra® Solostar®)'], 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value \\>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner).', 'armGroupLabels': ['Insulin Glulisine QD']}, {'name': 'Insulin glulisine TID', 'type': 'DRUG', 'otherNames': ['HMR1964', 'Device: Disposable self-injector prefilled pen (Apidra® Solostar®)'], 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value \\>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner).', 'armGroupLabels': ['Insulin Glulisine TID']}, {'name': 'Insulin Glargine (Mandatory background drug)', 'type': 'DRUG', 'otherNames': ['Device: Disposable self-injector prefilled pen (Lantus® Solostar®)'], 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).', 'armGroupLabels': ['Insulin Glulisine QD', 'Insulin Glulisine TID', 'Lixisenatide']}, {'name': 'Metformin (Background drug)', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.', 'armGroupLabels': ['Insulin Glulisine QD', 'Insulin Glulisine TID', 'Lixisenatide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840043', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840042', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840003', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840031', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840005', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840057', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840035', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840002', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840037', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '91345', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840023', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840041', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840012', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33142', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840061', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30045', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840045', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'Investigational Site Number 840036', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840024', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840009', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 840004', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 840055', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840027', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site Number 840006', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840047', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840056', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 840022', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840016', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840017', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '49620', 'city': 'Buckley', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840025', 'geoPoint': {'lat': 44.50445, 'lon': -85.67701}}, {'zip': '48124', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840048', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840026', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site Number 840049', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 840029', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '11787', 'city': 'Smithtown', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 840060', 'geoPoint': {'lat': 40.85593, 'lon': -73.20067}}, {'zip': '10301-3914', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 840030', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840011', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Investigational Site Number 840028', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 840007', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 840021', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840052', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 840032', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 840033', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840034', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840001', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840020', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number 840018', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '24153', 'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number 840015', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}, {'zip': '53217', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Investigational Site Number 840010', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'L6R 3J5', 'city': 'Brampton', 'country': 'Canada', 'facility': 'Investigational Site Number 124008', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L7M 4Y1', 'city': 'Burlington', 'country': 'Canada', 'facility': 'Investigational Site Number 124015', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'N7L 1C1', 'city': 'Chatham', 'country': 'Canada', 'facility': 'Investigational Site Number 124018', 'geoPoint': {'lat': 42.41224, 'lon': -82.18494}}, {'zip': 'V3K 3P4', 'city': 'Coquitlam', 'country': 'Canada', 'facility': 'Investigational Site Number 124004', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'zip': 'M9R 4E1', 'city': 'Etobicoke', 'country': 'Canada', 'facility': 'Investigational Site Number 124016', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'L8L 5G8', 'city': 'Hamilton', 'country': 'Canada', 'facility': 'Investigational Site Number 124014', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'H1Y 3L1', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124020', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A 1A1', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124011', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'country': 'Canada', 'facility': 'Investigational Site Number 124017', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'G1N 4V3', 'city': 'Québec', 'country': 'Canada', 'facility': 'Investigational Site Number 124021', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'T4N 6V7', 'city': 'Red Deer', 'country': 'Canada', 'facility': 'Investigational Site Number 124003', 'geoPoint': {'lat': 52.26682, 'lon': -113.802}}, {'zip': 'G6W 5M6', 'city': 'Saint Romuald', 'country': 'Canada', 'facility': 'Investigational Site Number 124012', 'geoPoint': {'lat': 46.75818, 'lon': -71.23921}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'country': 'Canada', 'facility': 'Investigational Site Number 124002', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'M4G 3E8', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 124001', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5C 2T2', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 124010', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Investigational Site Number 124005', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8V 4A1', 'city': 'Victoria', 'country': 'Canada', 'facility': 'Investigational Site Number 124006', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R3E 3P4', 'city': 'Winnipeg', 'country': 'Canada', 'facility': 'Investigational Site Number 124007', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': '7500010', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 152103', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7500347', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 152107', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7500710', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 152101', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7591047', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 152105', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7980378', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 152102', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8053095', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 152106', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8053095', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 152108', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 152109', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '26601', 'city': 'Beroun', 'country': 'Czechia', 'facility': 'Investigational Site Number 203107', 'geoPoint': {'lat': 49.96382, 'lon': 14.072}}, {'zip': '254 01', 'city': 'Jílové u Prahy', 'country': 'Czechia', 'facility': 'Investigational Site Number 203103', 'geoPoint': {'lat': 49.89545, 'lon': 14.49333}}, {'zip': '702 00', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Investigational Site Number 203101', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '549 54', 'city': 'Police nad Metují', 'country': 'Czechia', 'facility': 'Investigational Site Number 203110', 'geoPoint': {'lat': 50.53687, 'lon': 16.2335}}, {'zip': '14021', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number 203105', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '148 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number 203102', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': 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