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Ignite Creation Date: 2025-12-24 @ 10:47 PM

Ignite Modification Date: 2025-12-28 @ 3:21 PM

Study NCT ID: NCT03703869

Status: COMPLETED

Last Update Posted: 2022-04-25

First Post: 2018-10-09

Is NOT Gene Therapy: True

Has Adverse Events: False

Brief Title: Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4589}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2018-10-09', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c at month 6', 'timeFrame': 'Baseline, month 6', 'description': 'Percentage of patients achieving Hemoglobin A1c \\<7.0%.'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'Baseline, months 3, 6, 12', 'description': 'Change from baseline in HbA1c at 3, 6, and 12 months'}, {'measure': 'Change in fasting plasma glucose', 'timeFrame': 'Baseline, months 3, 6, 12', 'description': 'Change from baseline in Fasting Plasma Glucose at 3, 6, and 12 months'}, {'measure': 'Change in Self-Monitored Plasma Glucose', 'timeFrame': 'Baseline, months 3, 6, 12', 'description': 'Change from baseline in Self-Monitored Plasma Glucose at 3, 6, and 12 months'}, {'measure': 'Hypoglycemia', 'timeFrame': 'Baseline to month 12', 'description': 'Number of participants with symptomatic hypoglycemic events'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline to month 12', 'description': 'Number of participants with Adverse Events'}, {'measure': 'Serious adverse events', 'timeFrame': 'Baseline to month 12', 'description': 'Number of participants with Serious Adverse Events'}, {'measure': 'Body weight', 'timeFrame': 'Baseline to month 12', 'description': 'Change in average body weight'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '40920273', 'type': 'DERIVED', 'citation': 'Tirosh A, Khan N, Vargas-Uricoechea H, Galstyan G, Al Shaikh AR, Makkar BM, Mabunay MA, Melas-Melt L, Pilorget V, Karalliedde J. Effectiveness and Safety of Insulin Glargine 300 U/ml in High-Risk Subgroups (Renal Impairment and Older Age >/= 70 years) of Insulin-Naive People with Type 2 Diabetes: A Post hoc Analysis of Real-World ATOS Study. Diabetes Ther. 2025 Oct;16(10):2045-2061. doi: 10.1007/s13300-025-01785-w. Epub 2025 Sep 8.'}, {'pmid': '38355814', 'type': 'DERIVED', 'citation': 'Khan NE, Al Shaikh AAM, Hassoun AAK, Hassan AM, Salah MM, Al Abdella NA, Safarini SSM, Al Dahi WA, Akil YA. Real-World Study on Effectiveness of Insulin Glargine U300 After Oral Antidiabetic Drug Failure in Patients with Type 2 Diabetes in the Gulf Region. Diabetes Ther. 2024 Mar;15(3):691-704. doi: 10.1007/s13300-024-01537-2. Epub 2024 Feb 15.'}, {'pmid': '35532858', 'type': 'DERIVED', 'citation': 'Galstyan GR, Tirosh A, Vargas-Uricoechea H, Mabunay MA, Coudert M, Naqvi M, Pilorget V, Khan N. Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin-Naive People with Type 2 Diabetes: the ATOS Study. Diabetes Ther. 2022 Jun;13(6):1187-1202. doi: 10.1007/s13300-022-01266-4. Epub 2022 May 9.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nAssess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).\n\nSecondary Objectives:\n\n* Assess effectiveness in achieving glycemic goal measured by HbA1c;\n* Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;\n* Assess requirement for intensification of therapy by additional antidiabetics.\n* Assess incidence of hypoglycemia;\n* Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);\n* Assess change in body weight.', 'detailedDescription': 'Patients will be observed for one year'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Insulin-naïve patients with type 2 diabetes mellitus and Oral Antidiabetic Drug failure', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Signed patient informed consent;\n* Type 2 diabetes mellitus;\n* Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months;\n* Hemoglobin A1c (HbA1c) \\>7.0 % and ≤11% within 3 months of study baseline;\n* Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen\n\nExclusion criteria:\n\n* Diabetes mellitus other than type 2;\n* Contraindication to insulin glargine U300 according to local product labelling;\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03703869', 'acronym': 'ATOS', 'briefTitle': 'Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A 12-month Prospective Observational Study Assessing the Real-world Clinical Effectiveness, Safety and Health-economic Benefits of Toujeo® Initiation After Oral Antidiabetic Drug Failure in Insulin-naïve Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'OBS14708'}, 'secondaryIdInfos': [{'id': 'U1111-1215-0174', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Insulin glargine (U300)', 'description': 'Insulin glargine (U300) dosage and dosing time as per local product labeling', 'interventionNames': ['Drug: Insulin glargine (U300)']}], 'interventions': [{'name': 'Insulin glargine (U300)', 'type': 'DRUG', 'otherNames': ['HOE901, Toujeo, Toujeo Solostar'], 'description': 'Pharmaceutical form: Solution for injection\n\nRoute of administration: Subcutaneous injection', 'armGroupLabels': ['Insulin glargine (U300)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barranquilla', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700001', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700004', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700010', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700005', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700009', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Ibagué', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700003', 'geoPoint': {'lat': 4.43573, 'lon': -75.20289}}, {'zip': '170', 'city': 'Manizales', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700007', 'geoPoint': {'lat': 5.0668, 'lon': -75.50684}}, {'city': 'Popayán', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700006', 'geoPoint': {'lat': 2.43823, 'lon': -76.61316}}, {'city': 'Zipaquirá', 'country': 'Colombia', 'facility': 'Investigational Site Number 1700002', 'geoPoint': {'lat': 5.02208, 'lon': -74.00481}}, {'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180017', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'zip': '21575', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180015', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180007', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180008', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180012', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180018', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180001', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180005', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180006', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180016', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180020', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11535', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180003', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'zip': '28452', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180011', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180002', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180009', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180014', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Portsaeid', 'country': 'Egypt', 'facility': 'Investigational Site Number 8180013'}, {'zip': '380006', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Investigational Site Number 3560056', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380007', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Investigational Site Number 3560021', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380009', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Investigational Site Number 3560049', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380009', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Investigational Site Number 3560077', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380054', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Investigational Site Number 3560068', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '431001', 'city': 'Aurangabad', 'country': 'India', 'facility': 'Investigational Site Number 3560014', 'geoPoint': {'lat': 19.87757, 'lon': 75.34226}}, {'zip': '560005', 'city': 'Bangalore', 'country': 'India', 'facility': 'Investigational Site Number 3560081', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560019', 'city': 'Bangalore', 'country': 'India', 'facility': 'Investigational Site Number 3560088', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560078', 'city': 'Bangalore', 'country': 'India', 'facility': 'Investigational Site Number 3560066', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560079', 'city': 'Bangalore', 'country': 'India', 'facility': 'Investigational Site Number 3560009', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Investigational Site Number 3560059', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Investigational Site Number 3560064', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Investigational Site Number 3560075', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Investigational Site Number 3560122', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Belagavi', 'country': 'India', 'facility': 'Investigational Site Number 3560044', 'geoPoint': {'lat': 15.85212, 'lon': 74.50447}}, {'zip': '560003', 'city': 'Bengaluru', 'country': 'India', 'facility': 'Investigational Site Number 3560074', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560040', 'city': 'Bengaluru', 'country': 'India', 'facility': 'Investigational Site Number 3560046', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '751012', 'city': 'Bhabaneswar', 'country': 'India', 'facility': 'Investigational Site Number 3560116'}, {'zip': '751003', 'city': 'Bhubaneswar', 'country': 'India', 'facility': 'Investigational Site Number 3560062', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}, {'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Investigational Site Number 3560106', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'zip': '160043', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Investigational Site Number 3560126', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'zip': '600005', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560110', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600008', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560029', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600014', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560080', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600017', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560067', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600032', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560030', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600040', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560008', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600042', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560031', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600083', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560011', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600085', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560124', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600090', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560105', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600100', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560098', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600106', 'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560104', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Chennai', 'country': 'India', 'facility': 'Investigational Site Number 3560133', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '641004', 'city': 'Coimbatore', 'country': 'India', 'facility': 'Investigational Site Number 3560012', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '641009', 'city': 'Coimbatore', 'country': 'India', 'facility': 'Investigational Site Number 3560131', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '110005', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560032', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110017', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560041', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110021', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560108', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110060', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560002', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110063', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560019', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110063', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560047', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110076', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560102', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110085', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560020', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110087', 'city': 'Delhi', 'country': 'India', 'facility': 'Investigational Site Number 3560085', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '638011', 'city': 'Erode', 'country': 'India', 'facility': 'Investigational Site Number 3560118', 'geoPoint': {'lat': 11.3428, 'lon': 77.72741}}, {'zip': '781001', 'city': 'Guwahati', 'country': 'India', 'facility': 'Investigational Site Number 3560051', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '781005', 'city': 'Guwahati', 'country': 'India', 'facility': 'Investigational Site Number 3560094', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '781006', 'city': 'Guwahati', 'country': 'India', 'facility': 'Investigational Site Number 3560087', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '781006', 'city': 'Guwahati', 'country': 'India', 'facility': 'Investigational Site Number 3560113', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '781011', 'city': 'Guwahati', 'country': 'India', 'facility': 'Investigational Site Number 3560070', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '781022', 'city': 'Guwahati', 'country': 'India', 'facility': 'Investigational Site Number 3560097', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '474001', 'city': 'Gwalior', 'country': 'India', 'facility': 'Investigational Site Number 3560109', 'geoPoint': {'lat': 26.22983, 'lon': 78.17337}}, {'city': 'Haryāna', 'country': 'India', 'facility': 'Investigational Site Number 3560089', 'geoPoint': {'lat': 29.61611, 'lon': 76.98056}}, {'zip': '711201', 'city': 'Howrah', 'country': 'India', 'facility': 'Investigational Site Number 3560135', 'geoPoint': {'lat': 22.57688, 'lon': 88.31857}}, {'city': 'Howrah', 'country': 'India', 'facility': 'Investigational Site Number 3560096', 'geoPoint': {'lat': 22.57688, 'lon': 88.31857}}, {'zip': '500002', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560045', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500016', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560058', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500029', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560036', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500033', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560069', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500073', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560035', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500081', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560024', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560027', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560043', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560100', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'Investigational Site Number 3560107', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabd', 'country': 'India', 'facility': 'Investigational Site Number 3560034'}, {'zip': '302015', 'city': 'Jaipur', 'country': 'India', 'facility': 'Investigational Site Number 3560111', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '302015', 'city': 'Jaipur', 'country': 'India', 'facility': 'Investigational Site Number 3560123', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '302016', 'city': 'Jaipur', 'country': 'India', 'facility': 'Investigational Site Number 3560134', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '302018', 'city': 'Jaipur', 'country': 'India', 'facility': 'Investigational Site Number 3560017', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Jaipur', 'country': 'India', 'facility': 'Investigational Site Number 3560022', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '144003', 'city': 'Jalandhar', 'country': 'India', 'facility': 'Investigational Site Number 3560073', 'geoPoint': {'lat': 31.32556, 'lon': 75.57917}}, {'zip': '208002', 'city': 'Kanpur', 'country': 'India', 'facility': 'Investigational Site Number 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'400053', 'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number 3560136', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400064', 'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number 3560042', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400068', 'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number 3560065', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400092', 'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number 3560015', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400601', 'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number 3560079', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number 3560003', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number 3560023', 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'Investigational Site Number 3560114', 'geoPoint': {'lat': 13.08879, 'lon': 75.56248}}, {'zip': '695033', 'city': 'Trivandrum', 'country': 'India', 'facility': 'Investigational Site Number 3560039', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}, {'city': 'Trivandrum', 'country': 'India', 'facility': 'Investigational Site Number 3560013', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}, {'zip': '520002', 'city': 'Vijayawada', 'country': 'India', 'facility': 'Investigational Site Number 3560127', 'geoPoint': {'lat': 16.50745, 'lon': 80.6466}}, {'zip': '530002', 'city': 'Visakhapatnam', 'country': 'India', 'facility': 'Investigational Site Number 3560061', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '530016', 'city': 'Visakhapatnam', 'country': 'India', 'facility': 'Investigational Site Number 3560054', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'city': 'Yamuna Nagar', 'country': 'India', 'facility': 'Investigational Site Number 3560128', 'geoPoint': {'lat': 30.12796, 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'Investigational Site Number 3760003', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Investigational Site Number 3760004', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '11183', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Investigational Site Number 4000002', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'zip': '11183', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Investigational Site Number 4000005', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'zip': '11183', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Investigational Site Number 4000006', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'zip': '11183', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Investigational Site Number 4000008', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'city': 'Amman', 'country': 'Jordan', 'facility': 'Investigational Site Number 0004', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'city': 'Amman', 'country': 'Jordan', 'facility': 'Investigational Site Number 4000009', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'zip': '211-81', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'Investigational Site Number 0007', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}, {'city': 'Al Jabriya', 'country': 'Kuwait', 'facility': 'Investigational Site Number 4140001'}, {'city': 'Al Jabriya', 'country': 'Kuwait', 'facility': 'Investigational Site Number 4140010'}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Investigational Site Number 4140003', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Investigational Site Number 4140004', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Investigational Site Number 4140006', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Investigational Site Number 4140009', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Investigational Site Number 4140011', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Investigational Site Number 4140012', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Airport Road', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220017'}, {'city': 'Aley', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220008', 'geoPoint': {'lat': 33.80528, 'lon': 35.6}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220001', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220015', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Bir Al Abed', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220012'}, {'city': 'Chtoura', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220007'}, {'city': 'Corniche El Mazraa', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220011'}, {'city': 'El Achrafiyé', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220006', 'geoPoint': {'lat': 33.88533, 'lon': 35.51961}}, {'city': 'El Achrafiyé', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220016', 'geoPoint': {'lat': 33.88533, 'lon': 35.51961}}, {'city': 'Hadath', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220018'}, {'city': 'Hamra', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220013', 'geoPoint': {'lat': 33.89583, 'lon': 35.48306}}, {'city': 'Jal El Baher', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220019'}, {'city': 'Jounieh', 'country': 'Lebanon', 'facility': 'Investigational Site Number 4220014', 'geoPoint': {'lat': 33.98083, 'lon': 35.61778}}, {'city': 'Metn', 'country': 'Lebanon', 'facility': 'Investigational Site Number 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'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Investigational Site Number 6430171', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Investigational Site Number 6430172', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '414018', 'city': 'Astrakhan', 'country': 'Russia', 'facility': 'Investigational Site Number 6430019', 'geoPoint': {'lat': 46.34968, 'lon': 48.04076}}, {'zip': '656050', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Investigational Site Number 6430010', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '656050', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Investigational Site Number 6430138', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '656056', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Investigational Site Number 6430081', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '656056', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Investigational Site Number 6430182', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '656066', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Investigational Site Number 6430160', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '656922', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Investigational Site Number 6430181', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '352630', 'city': 'Belorechensk', 'country': 'Russia', 'facility': 'Investigational Site Number 6430157', 'geoPoint': {'lat': 44.77002, 'lon': 39.87246}}, {'zip': '241047', 'city': 'Bryansk', 'country': 'Russia', 'facility': 'Investigational Site Number 6430156', 'geoPoint': {'lat': 53.27096, 'lon': 34.32143}}, {'zip': '346801', 'city': 'Chaltyr', 'country': 'Russia', 'facility': 'Investigational Site Number 6430060', 'geoPoint': {'lat': 47.28477, 'lon': 39.48232}}, {'zip': '428009', 'city': 'Cheboksary', 'country': 'Russia', 'facility': 'Investigational Site Number 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Number 7840012', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Investigational Site Number 7840013', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Investigational Site Number 7840014', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Investigational Site Number 7840015', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Investigational Site Number 7840016', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Umm Al Quwain City', 'country': 'United Arab Emirates', 'facility': 'Investigational Site Number 7840019', 'geoPoint': {'lat': 25.56473, 'lon': 55.55517}}, {'city': 'Umm Al Quwain City', 'country': 'United Arab Emirates', 'facility': 'Investigational Site Number 7840020', 'geoPoint': {'lat': 25.56473, 'lon': 55.55517}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}