Viewing Study NCT01117350

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Ignite Creation Date: 2025-12-24 @ 5:05 PM
Ignite Modification Date: 2026-01-04 @ 4:25 AM
Study NCT ID: NCT01117350
Status: COMPLETED
Last Update Posted: 2014-04-11
First Post: 2010-05-04
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D000069450', 'term': 'Liraglutide'}, {'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': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'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 abstract/manuscript for comment at least 20/45 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': 'Adverse events were collected throughout the study from the time the patient signed the informed consent until 7 days after the last dose of study treatment.', 'description': 'The population analyzed was the safety population defined for each of the 2 periods (comparative and extension) as the patients treated with at least one dose of the study treatment during the considered period.', 'eventGroups': [{'id': 'EG000', 'title': 'Comparative Period: Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days', 'otherNumAtRisk': 484, 'otherNumAffected': 92, 'seriousNumAtRisk': 484, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Comparative Period: Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)', 'otherNumAtRisk': 481, 'otherNumAffected': 239, 'seriousNumAtRisk': 481, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Extension Period: Insulin Glargine', 'description': 'Following a treatment with liraglutide during the comparative period, those patients have received insulin glargine during the extension period.\n\nInsulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days', 'otherNumAtRisk': 160, 'otherNumAffected': 22, 'seriousNumAtRisk': 160, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 146}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 484, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '45.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.439', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.54', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '8.93', 'pValueComment': 'If superiority not demonstrated, switching from superiority to non-inferiority considered.\n\nConclusion of non-inferiority reached if lower limit of 2-sided 95% confidence interval of the difference (insulin glargine - liraglutide) \\> or = to - 3.5%', 'groupDescription': 'Superiority testing\n\nH0: Rate measured with insulin glargine = rate measured with liraglutide\n\nH1: Rate measured with insulin glargine ≠ rate measured with liraglutide\n\nSample size calculation (465 randomized patients per arm) was based on the assumption of an expected success rate of 46% with insulin glargine and 35% with liraglutide, an alpha risk of 5% (2-sided) and a power of 90%, taking into account an estimated non evaluability rate of 10%.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'week 12, week 24', 'description': 'The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward \\[LOCF\\] value).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}, {'value': '46.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline (week -2), week 12, week 24', 'description': 'Percentage of patients with:\n\n\\* HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value\n\nAND\n\n\\* HbA1c value at end of the comparative period (LOCF) ≥7%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline (week -2), week 12, week 24', 'description': 'Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.'}, {'type': 'SECONDARY', 'title': 'Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.92', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (week -2), week 12, week 24', 'description': 'Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.'}, {'type': 'SECONDARY', 'title': 'Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine (Extension Period)', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '1.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 24, week 36, week 48', 'description': 'Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the subset of mITT population (extension) who had HbA1c value both at beginning of the extension and at least one value on treatment during the extension period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine (Extension Period)', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 36, week 48', 'description': 'Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the mITT patients who had at least one HbA1c value on treatment during the extension period.'}, {'type': 'SECONDARY', 'title': 'Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '452', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-65.25', 'spread': '50.95', 'groupId': 'OG000'}, {'value': '-37.23', 'spread': '47.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (week 0), week 6, week 12, week 18, week 24', 'description': 'SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit\n\nValue at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward \\[LOCF\\] value)\n\nChange = LOCF value - baseline value', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one SMFPG value on treatment during the comparative period.'}, {'type': 'SECONDARY', 'title': 'Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine (Extension Period)', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.63', 'spread': '45.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 24, week 30, week 36, week 48', 'description': 'SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit\n\nValue at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward \\[LOCF\\] value)\n\nChange = LOCF value - week 24 value', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the subset of mITT (extension) patients who had SMFPG value both at beginning of the extension and at least one value on treatment during the extension period.'}, {'type': 'SECONDARY', 'title': 'Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'title': 'Before breakfast (N ig = 448 & N l = 409)', 'categories': [{'measurements': [{'value': '-65.92', 'spread': '50.29', 'groupId': 'OG000'}, {'value': '-38.64', 'spread': '46.17', 'groupId': 'OG001'}]}]}, {'title': 'After breakfast (N ig = 440 & N l = 397)', 'categories': [{'measurements': [{'value': '-66.70', 'spread': '63.29', 'groupId': 'OG000'}, {'value': '-55.35', 'spread': '61.56', 'groupId': 'OG001'}]}]}, {'title': 'Before lunch (N ig = 438 & N l = 404)', 'categories': [{'measurements': [{'value': '-50.16', 'spread': '59.53', 'groupId': 'OG000'}, {'value': '-39.13', 'spread': '58.78', 'groupId': 'OG001'}]}]}, {'title': 'After lunch (N ig = 433 & N l = 406)', 'categories': [{'measurements': [{'value': '-43.00', 'spread': '58.42', 'groupId': 'OG000'}, {'value': '-41.82', 'spread': '61.16', 'groupId': 'OG001'}]}]}, {'title': 'Before dinner (N ig = 434 & N l = 400)', 'categories': [{'measurements': [{'value': '-40.84', 'spread': '58.88', 'groupId': 'OG000'}, {'value': '-36.88', 'spread': '58.49', 'groupId': 'OG001'}]}]}, {'title': 'After dinner (N ig = 426 & N l = 396)', 'categories': [{'measurements': [{'value': '-42.6', 'spread': '61.74', 'groupId': 'OG000'}, {'value': '-45.04', 'spread': '60.42', 'groupId': 'OG001'}]}]}, {'title': 'At bedtime (N ig = 380 & N l = 351)', 'categories': [{'measurements': [{'value': '-43.11', 'spread': '60.37', 'groupId': 'OG000'}, {'value': '-44.06', 'spread': '59.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (week 0), week 12, week 24', 'description': 'Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit\n\nValue at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward \\[LOCF\\] value)\n\nChange = LOCF value - baseline value', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed for each time point of the profile.'}, {'type': 'SECONDARY', 'title': 'Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine (Extension Period)', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days'}], 'classes': [{'title': 'Before breakfast (N=143)', 'categories': [{'measurements': [{'value': '-46.13', 'spread': '44.89', 'groupId': 'OG000'}]}]}, {'title': 'After breakfast (N=134)', 'categories': [{'measurements': [{'value': '-27.67', 'spread': '52.37', 'groupId': 'OG000'}]}]}, {'title': 'Before lunch (N=131)', 'categories': [{'measurements': [{'value': '-20.32', 'spread': '57.58', 'groupId': 'OG000'}]}]}, {'title': 'After lunch (N=134)', 'categories': [{'measurements': [{'value': '-11.50', 'spread': '58.37', 'groupId': 'OG000'}]}]}, {'title': 'Before dinner (N=133)', 'categories': [{'measurements': [{'value': '-12.56', 'spread': '54.57', 'groupId': 'OG000'}]}]}, {'title': 'After dinner (N=130)', 'categories': [{'measurements': [{'value': '-2.28', 'spread': '54.55', 'groupId': 'OG000'}]}]}, {'title': 'At bedtime (N=127)', 'categories': [{'measurements': [{'value': '-14.94', 'spread': '52.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 24, week 36, week 48', 'description': 'Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit\n\nValue at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward \\[LOCF\\] value)\n\nChange = LOCF value - week 24 value', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population considered was the mITT population (extension) but due to missing values, different subsets of this population were analyzed for each time point of the profile.'}, {'type': 'SECONDARY', 'title': 'Body Weight: Change From Baseline to the End of the Comparative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'spread': '3.95', 'groupId': 'OG000'}, {'value': '-2.99', 'spread': '3.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (week 0), week 2, week 6, week 12, week 18, week 24', 'description': 'Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one weight value on treatment during the comparative period.'}, {'type': 'SECONDARY', 'title': 'Body Weight: Change From Beginning to End of the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine (Extension Period)', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '4.35', 'spread': '3.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 24, week 30, week 36, week 48', 'description': 'Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome measure consisted of the mITT population (extension).'}, {'type': 'SECONDARY', 'title': 'Daily Dose of Insulin Glargine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}], 'classes': [{'title': 'Start of treatment (N=472)', 'categories': [{'measurements': [{'value': '13.39', 'spread': '4.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 (N=470)', 'categories': [{'measurements': [{'value': '17.74', 'spread': '6.52', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 (N=470)', 'categories': [{'measurements': [{'value': '22.06', 'spread': '8.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (N=470)', 'categories': [{'measurements': [{'value': '34.67', 'spread': '17.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (N=463)', 'categories': [{'measurements': [{'value': '44.40', 'spread': '26.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 18 (N=454)', 'categories': [{'measurements': [{'value': '48.65', 'spread': '31.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (N=459)', 'categories': [{'measurements': [{'value': '51.67', 'spread': '34.05', 'groupId': 'OG000'}]}]}, {'title': 'End comparative period (LOCF) (N=474)', 'categories': [{'measurements': [{'value': '51.24', 'spread': '33.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 1, week 2, week 6, week 12, week 24', 'unitOfMeasure': 'Unit (U)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.'}, {'type': 'SECONDARY', 'title': 'Daily Dose of Liraglutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'title': 'Start of treatment (N=470)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 (N=463)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 (N=458)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '0.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (N=444)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (N=426)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 18 (N=415)', 'categories': [{'measurements': [{'value': '1.74', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (N=431)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'End comparative period (LOCF) (N=470)', 'categories': [{'measurements': [{'value': '1.71', 'spread': '0.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 1, week 2, week 6, week 12, week 24', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.'}, {'type': 'SECONDARY', 'title': 'Daily Dose of Insulin Glargine Administered During the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine (Extension Period)', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days'}], 'classes': [{'title': 'Start of treatment (N=154)', 'categories': [{'measurements': [{'value': '15.77', 'spread': '4.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 30 (N=151)', 'categories': [{'measurements': [{'value': '37.49', 'spread': '15.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 36 (N=150)', 'categories': [{'measurements': [{'value': '46.21', 'spread': '23.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (N=151)', 'categories': [{'measurements': [{'value': '50.68', 'spread': '27.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 30, week 36, week 48', 'unitOfMeasure': 'Unit (U)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population considered was the mITT population (extension) but due to missing values, different subsets of this mITT population were analyzed at each week.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '484', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}], 'classes': [{'title': 'symptomatic hypoglycemia', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'severe symptomatic hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'all across the comparative period (from week 0 to week 24)', 'description': 'Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.\n\nSevere symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:\n\n* The event was associated with a measured PG level \\< 36 mg/dL (2 mmol/L),\n* Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was the safety population i.e. all randomized and treated patients.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine (Extension Period)', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days'}], 'classes': [{'title': 'symptomatic hypoglycemia', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'severe symptomatic hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'all across the extension period (from week 24 to week 48)', 'description': 'Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.\n\nSevere symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:\n\n* The event was associated with a measured PG level \\< 36 mg/dL (2 mmol/L),\n* Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was the safety population (extension) i.e. all treated patients during the extension period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days'}, {'id': 'FG001', 'title': 'Liraglutide (Comparative Period)/ Insulin Glargine (Extension)', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)\n\nFor patients included in the extension period: Insulin Glargine (dosing same as above)'}], 'periods': [{'title': 'Comparative Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'STARTED: randomized', 'groupId': 'FG000', 'numSubjects': '489'}, {'groupId': 'FG001', 'numSubjects': '489'}]}, {'type': 'TREATED = Safety Population', 'achievements': [{'comment': 'Safety population: all randomized and treated patients (received at least one dose)', 'groupId': 'FG000', 'numSubjects': '484'}, {'groupId': 'FG001', 'numSubjects': '481'}]}, {'type': 'mITT Population', 'achievements': [{'comment': 'modified Intent-To-Treat population: treated patients with at least one efficacy post-baseline value', 'groupId': 'FG000', 'numSubjects': '474'}, {'groupId': 'FG001', 'numSubjects': '470'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '447'}, {'groupId': 'FG001', 'numSubjects': '414'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '75'}]}], 'dropWithdraws': [{'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Move to another city/country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'STARTED: patients having completed the comparative period and eligible for the extension period', 'groupId': 'FG001', 'numSubjects': '210'}]}, {'type': 'TREATED = Safety Population (Extension)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Safety population (extension): treated with insulin glargine during the extension period', 'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'mITT Population (Extension)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'mITT (extension): treated patients with at least 1 efficacy value both at entry and during extension', 'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Not included in extension, not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Inclusion criteria not respected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Prohibited medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The first patient was enrolled on July 23, 2010. The 24-week comparative period was completed on October 5, 2012.\n\nThe extension period was initiated on March 24, 2011 and completed on March 6, 2013.', 'preAssignmentDetails': 'A total of 1456 patients were screened in 136 centers, in 17 countries (Austria, Brazil, Canada, Czech Republic, Finland, France, Greece, Ireland, Israel, Mexico, Netherlands, Russian Federation Slovakia, Spain, Sweden, Turkey, USA). Among them, 478 (32.8%) patients were not randomized (main reason was Glycosylated Haemoglobin A1c out of range).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'BG000'}, {'value': '470', 'groupId': 'BG001'}, {'value': '944', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Glargine', 'description': 'Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.'}, {'id': 'BG001', 'title': 'Liraglutide', 'description': 'Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.07', 'spread': '8.78', 'groupId': 'BG000'}, {'value': '57.44', 'spread': '8.85', 'groupId': 'BG001'}, {'value': '57.25', 'spread': '8.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI) at week -2', 'classes': [{'categories': [{'measurements': [{'value': '32.00', 'spread': '4.24', 'groupId': 'BG000'}, {'value': '31.75', 'spread': '4.12', 'groupId': 'BG001'}, {'value': '31.88', 'spread': '4.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Type 2 diabetes', 'classes': [{'categories': [{'measurements': [{'value': '8.54', 'groupId': 'BG000', 'lowerLimit': '5.20', 'upperLimit': '12.38'}, {'value': '8.41', 'groupId': 'BG001', 'lowerLimit': '4.80', 'upperLimit': '11.69'}, {'value': '8.49', 'groupId': 'BG002', 'lowerLimit': '4.94', 'upperLimit': '12.17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'At least one diabetic late complication', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Diabetic late complications: myocardial infarction, angina pectoris, coronary artery disease, heart failure, stroke, transient ischemic attack, peripheral vascular disease, diabetic neuropathy, diabetic nephropathy, diabetic retinopathy', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated Hemoglobin A1c (HbA1c) at week -2', 'classes': [{'categories': [{'measurements': [{'value': '9.04', 'spread': '1.10', 'groupId': 'BG000'}, {'value': '9.11', 'spread': '1.09', 'groupId': 'BG001'}, {'value': '9.07', 'spread': '1.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Modified-Intent-to-treat (mITT) population: all patients who were randomized, received at least one dose of Interventional Product (IP), and had at least one post-baseline assessment during comparative period of any primary or secondary efficacy variables'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 978}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-05', 'studyFirstSubmitDate': '2010-05-04', 'resultsFirstSubmitDate': '2013-10-04', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-11', 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period', 'timeFrame': 'week 12, week 24', 'description': 'The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward \\[LOCF\\] value).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period', 'timeFrame': 'baseline (week -2), week 12, week 24', 'description': 'Percentage of patients with:\n\n\\* HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value\n\nAND\n\n\\* HbA1c value at end of the comparative period (LOCF) ≥7%'}, {'measure': 'Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period', 'timeFrame': 'baseline (week -2), week 12, week 24', 'description': 'Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value'}, {'measure': 'Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period', 'timeFrame': 'baseline (week -2), week 12, week 24', 'description': 'Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value'}, {'measure': 'Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period', 'timeFrame': 'week 24, week 36, week 48', 'description': 'Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value'}, {'measure': 'Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period', 'timeFrame': 'week 36, week 48', 'description': 'Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)'}, {'measure': 'Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period', 'timeFrame': 'baseline (week 0), week 6, week 12, week 18, week 24', 'description': 'SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit\n\nValue at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward \\[LOCF\\] value)\n\nChange = LOCF value - baseline value'}, {'measure': 'Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period', 'timeFrame': 'week 24, week 30, week 36, week 48', 'description': 'SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit\n\nValue at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward \\[LOCF\\] value)\n\nChange = LOCF value - week 24 value'}, {'measure': 'Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period', 'timeFrame': 'baseline (week 0), week 12, week 24', 'description': 'Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit\n\nValue at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward \\[LOCF\\] value)\n\nChange = LOCF value - baseline value'}, {'measure': 'Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period', 'timeFrame': 'week 24, week 36, week 48', 'description': 'Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit\n\nValue at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward \\[LOCF\\] value)\n\nChange = LOCF value - week 24 value'}, {'measure': 'Body Weight: Change From Baseline to the End of the Comparative Period', 'timeFrame': 'baseline (week 0), week 2, week 6, week 12, week 18, week 24', 'description': 'Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline'}, {'measure': 'Body Weight: Change From Beginning to End of the Extension Period', 'timeFrame': 'week 24, week 30, week 36, week 48', 'description': 'Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)'}, {'measure': 'Daily Dose of Insulin Glargine', 'timeFrame': 'week 1, week 2, week 6, week 12, week 24'}, {'measure': 'Daily Dose of Liraglutide', 'timeFrame': 'week 1, week 2, week 6, week 12, week 24'}, {'measure': 'Daily Dose of Insulin Glargine Administered During the Extension Period', 'timeFrame': 'week 30, week 36, week 48'}, {'measure': 'Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period', 'timeFrame': 'all across the comparative period (from week 0 to week 24)', 'description': 'Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.\n\nSevere symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:\n\n* The event was associated with a measured PG level \\< 36 mg/dL (2 mmol/L),\n* Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.'}, {'measure': 'Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period', 'timeFrame': 'all across the extension period (from week 24 to week 48)', 'description': 'Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.\n\nSevere symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:\n\n* The event was associated with a measured PG level \\< 36 mg/dL (2 mmol/L),\n* Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nTo demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) \\< 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents\n\nSecondary objectives of the comparative period (24 weeks):\n\n\\>To assess the effect of insulin glargine in comparison with liraglutide on:\n\n* HbA1c level\n* Percentage of patients whose HbA1c has decreased but remains \\>= 7% at the end of the comparative period\n* Percentage of patients whose HbA1c has increased at the end of the comparative period\n* Fasting Plasma Glucose (FPG)\n* 7-point Plasma Glucose (PG) profiles\n* Hypoglycemia occurrence\n* Body weight\n* Adverse events\n\nObjectives of the extension period (24 weeks):\n\n\\>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:\n\n* HbA1c level\n* FPG\n* 7-point PG profiles\n* Hypoglycemia occurrence\n* Body weight\n* Adverse events', 'detailedDescription': 'Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow:\n\n* A 2-week of screening period,\n* A 24-week comparative period,\n* A 24-week extension period (only for patients treated with liraglutide, not adequately controlled at the end of the comparative period),\n* A 1-week follow-up period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria (comparative period):\n\n* Patients With Type 2 Diabetes diagnosed for at least 1 year,\n* Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months,\n* 7.5% \\< HbA1c \\<= 12%,\n* Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively,\n* Ability and willingness to perform PG (Plasma Glucose) self monitoring using the sponsor-provided glucose meter and to complete the patient diary,\n* Willingness and ability to comply with the study protocol,\n* Signed informed consent obtained prior to any study procedure.\n\nInclusion criteria (extension period):\n\n* Patients treated with liraglutide (at the maximal tolerated dosage), having a mean FPG ≥ 250 mg/dL at visit 10 (Week 12) or visit 11 (Week 18), or a HbA1c≥ 7% at visit 12 (Week 24)\n* Dosage of metformin compliant with the inclusion criteria of visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period.\n\nExclusion criteria:\n\n* Previous treatment with Glucagon Like Peptide-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization...),\n* Treatment with thiazolidinediones or α-Glucosidases inhibitors within 3 months prior to study entry,\n* Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake),\n* Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method),\n* Lactating women,\n* Hospitalized patients (except hospitalization for routine diabetes check-up),\n* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,\n* Impaired renal function (creatinine clearance \\< 60 mL/mn),\n* Impaired hepatic function (Alanine Aminotransferase, Aspartate Aminotransferase 2.5 times the upper limit of normal range),\n* Personal or family history of medullary thyroid carcinoma,\n* Multiple endocrine neoplasia syndrome type 2,\n* Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis),\n* Congestive heart failure,\n* History of acute pancreatitis,\n* Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry,\n* Alcohol or drug abuse in the past 5 years,\n* History of sensitivity to the study drugs or to drugs with a similar chemical structure.\n* Night shift worker,\n* Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patients safety or limit the patient successful participation in the study,\n* Participation in a clinical trial (drug or device) within 3 months prior to study entry,\n* Refusal or inability to give informed consent to participate in the study,\n* Patient is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.\n\nAdditional exclusion criteria for the extension period:\n\n* Treatment with oral antidiabetic drugs other than metformin and patient's usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),\n* Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period.\n* History of sensitivity to insulin glargine."}, 'identificationModule': {'nctId': 'NCT01117350', 'acronym': 'EAGLE', 'briefTitle': 'Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide', 'orgStudyIdInfo': {'id': 'LANTU_C_03680'}, 'secondaryIdInfos': [{'id': '2010-018437-21', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1116-9684', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Glargine', 'description': "Insulin glargine administered once a day, in the morning or in the evening, at the most convenient time. The time of injection, once chosen was to remain unchanged during the whole duration of the study.\n\nThe starting dose was 0.2 Unit per kilogram of body weight or 10 Units. Patients were empowered to adjust their insulin doses, under strict investigator's supervision. Insulin titration (by 2 or 4 Units) was done every 3 days according to the median value of Fasting Plasma Glucose (FPG) of the last 3 days. The goal was to achieve 70 \\< FPG ≤ 100 mg/dL (3.9 \\< FPG ≤ 5.5 mmol/L). Minor deviations from the titration scheme could be allowed, based on Investigator's judgment and patient's situation.", 'interventionNames': ['Drug: Insulin glargine', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liraglutide', 'description': "Liraglutide administered once a day, in the morning or in the evening, at the most convenient time. The time of injection , once chosen was to remain unchanged during the whole duration of the study.\n\nThe dose was 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24. The dose might be decreased to 1.2 mg for safety reasons (e.g. gastro-intestinal tolerability), based on Investigator's judgment.", 'interventionNames': ['Drug: Liraglutide', 'Drug: Metformin']}], 'interventions': [{'name': 'Insulin glargine', 'type': 'DRUG', 'otherNames': ['Lantus®'], 'description': '100 Units/mL solution for injection in a pre-filled SoloStar pen', 'armGroupLabels': ['Insulin Glargine']}, {'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza®'], 'description': '6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg)', 'armGroupLabels': ['Liraglutide']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin was a background treatment, mandatory for each patient randomized in the study (at the minimum dose of 1g/day). It was not supplied by the sponsor.', 'armGroupLabels': ['Insulin Glargine', 'Liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840023', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840002', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840047', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840017', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840036', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840037', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840045', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840048', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840033', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840019', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '92101', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840039', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840042', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840043', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840028', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840034', 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840026', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840022', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840029', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '60004', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840009', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840051', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46222', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 840050', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site Number 840031', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840004', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840010', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '55122', 'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site Number 840038', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}, {'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site Number 840030', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 840012', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 840044', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08004', 'city': 'Atco', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number 840015', 'geoPoint': {'lat': 39.76984, 'lon': -74.88739}}, {'zip': '08012', 'city': 'Blackwood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number 840008', 'geoPoint': {'lat': 39.80234, 'lon': -75.06406}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 840027', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10301-3914', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 840011', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840005', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840052', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Investigational Site Number 840049', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43506', 'city': 'Bryan', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 840006', 'geoPoint': {'lat': 41.47477, 'lon': -84.55245}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 840035', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '15106', 'city': 'Carnegie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 840016', 'geoPoint': {'lat': 40.40868, 'lon': -80.08339}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 840020', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Investigational Site Number 840024', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840001', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840007', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840013', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigational Site Number 840014', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '99220-3649', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigational Site Number 840046', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '5010', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Investigational Site Number 040-006', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Investigational Site Number 040-007', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': 'A-2000', 'city': 'Stockerau', 'country': 'Austria', 'facility': 'Investigational Site Number 040-003', 'geoPoint': {'lat': 48.38333, 'lon': 16.21667}}, {'zip': 'A-1010', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040-005', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040-002', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040-001', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1220', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040-004', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '66073-000', 'city': 'Belém', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-004', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}, {'zip': '60015-052', 'city': 'Fortaleza', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-007', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '60115-282', 'city': 'Fortaleza', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-001', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '60430-370', 'city': 'Fortaleza', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-006', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '17519-101', 'city': 'Marília', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-005', 'geoPoint': {'lat': -22.21389, 'lon': -49.94583}}, {'zip': '01244-030', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-002', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'L5M2V8', 'city': 'Mississauga', 'country': 'Canada', 'facility': 'Investigational Site Number 124-003', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'H2W1T8', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124-001', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A1A1', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124-006', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'M5C 2T2', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 124-004', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'V5Z1M9', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Investigational Site Number 124-008', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R1J8', 'city': 'Victoria', 'country': 'Canada', 'facility': 'Investigational Site Number 124-007', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Investigational Site Number 203001', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '79401', 'city': 'Krnov', 'country': 'Czechia', 'facility': 'Investigational Site Number 203003', 'geoPoint': {'lat': 50.08967, 'lon': 17.70385}}, {'zip': '76701', 'city': 'Kroměříž', 'country': 'Czechia', 'facility': 'Investigational Site Number 203005', 'geoPoint': {'lat': 49.29785, 'lon': 17.39312}}, {'zip': '77900', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Investigational Site Number 203002', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '15000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number 203006', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '29200', 'city': 'Harjavalta', 'country': 'Finland', 'facility': 'Investigational Site Number 246003', 'geoPoint': {'lat': 61.31667, 'lon': 22.13333}}, {'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Investigational Site Number 246001', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '90100', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Investigational Site Number 246002', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'Investigational Site Number 246004', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '74000', 'city': 'Annecy', 'country': 'France', 'facility': 'Investigational Site Number 250-007', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '76233', 'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Investigational Site Number 250-017', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Investigational Site Number 250-003', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '29000', 'city': 'Brest', 'country': 'France', 'facility': 'Investigational Site Number 250-011', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '46005', 'city': 'Cahors', 'country': 'France', 'facility': 'Investigational Site Number 250-008', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'zip': '91100', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Investigational Site Number 250-012', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'facility': 'Investigational Site Number 250-009', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '71200', 'city': 'Le Creusot', 'country': 'France', 'facility': 'Investigational Site Number 250-004', 'geoPoint': {'lat': 46.80714, 'lon': 4.41632}}, {'zip': '78200', 'city': 'Mantes-la-Jolie', 'country': 'France', 'facility': 'Investigational Site Number 250-006', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'zip': '92014', 'city': 'Nanterre', 'country': 'France', 'facility': 'Investigational Site Number 250-021', 'geoPoint': {'lat': 48.89198, 'lon': 2.20675}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Investigational Site Number 250022', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Investigational Site Number 250-020', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Investigational Site Number 250-002', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '69200', 'city': 'Vénissieux', 'country': 'France', 'facility': 'Investigational Site Number 250-016', 'geoPoint': {'lat': 45.69706, 'lon': 4.88593}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Investigational Site Number 300003', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Investigational Site Number 300004', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12462', 'city': 'Haidari, Athens', 'country': 'Greece', 'facility': 'Investigational Site Number 300001', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Investigational Site Number 372001', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Hadera', 'country': 'Israel', 'facility': 'Investigational Site Number 376004', 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'Investigational Site Number 528005', 'geoPoint': {'lat': 52.085, 'lon': 4.88333}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Investigational Site Number 643-009', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '610014K', 'city': 'Kirov', 'country': 'Russia', 'facility': 'Investigational Site Number 643008', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '117036', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Investigational Site Number 643001', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '195257', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigational Site Number 643004', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Investigational Site Number 643006', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Investigational Site Number 643007', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Saratov', 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