Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-08 @ 1:48 AM
Study NCT ID:
NCT02688933
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from signature of informed consent form up to study completion (Week 16) regardless of seriousness or relationship to study drug.', 'description': 'Reported AEs are treatment-emergent AEs developed/worsened during on treatment period (time from first dose of investigational medicinal product \\[IMP\\] up to one day after last dose of IMP).', 'eventGroups': [{'id': 'EG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.', 'otherNumAtRisk': 320, 'deathsNumAtRisk': 320, 'otherNumAffected': 54, 'seriousNumAtRisk': 320, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.', 'otherNumAtRisk': 318, 'deathsNumAtRisk': 318, 'otherNumAffected': 54, 'seriousNumAtRisk': 318, 'deathsNumAffected': 0, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}], 'seriousEvents': [{'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypoglycaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.40', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '55.18', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8494', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square mean difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.22', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.15', 'groupDescription': 'Analysis was performed using generalized linear model with identity link, had percentage of time glucose concentration within target range 70-180 mg/dL as dependent variable, treatment group as an independent variable, adjusting variables including baseline characteristics: duration of diabetes, baseline BMI, age, and randomization strata (HbA1c at screening \\[\\<8.0% vs ≥8.0%\\], frequency of Lantus injection at screening, current CGM use \\[yes/no\\], and mealtime insulin titration algorithm).', 'statisticalMethod': 'Generalized linear model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear model with identity link'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'During Week 15 and/or 16', 'description': 'The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population that included all participants who were randomized and had a post-baseline CGM assessment and enough CGM data values to calculate the primary outcome measure, percent of time in range of 70-180 mg/dL during Week 15 (and/or Week 16).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'classes': [{'title': 'Documented <=70mg/dL', 'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}]}]}, {'title': 'Documented <54 mg/dL', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '54.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16', 'description': 'Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG \\<=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'classes': [{'title': 'Documented <=70 mg/dL', 'categories': [{'measurements': [{'value': '11.38', 'groupId': 'OG000'}, {'value': '11.39', 'groupId': 'OG001'}]}]}, {'title': 'Documented <54 mg/dL', 'categories': [{'measurements': [{'value': '4.99', 'groupId': 'OG000'}, {'value': '5.61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16', 'description': 'Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG \\<=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF.', 'unitOfMeasure': 'events per participant-year', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '5.67', 'spread': '3.72', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, during Week 15 and/or Week 16', 'description': "Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.49', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '35.07', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'During Week 15 and/or Week 16', 'description': "Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).", 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Coefficient of Variation (CV%) in Mean CGM Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'classes': [{'title': 'Total CV%', 'categories': [{'measurements': [{'value': '41.27', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '40.72', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Within-day CV%', 'categories': [{'measurements': [{'value': '36.99', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '36.23', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Between-days CV%', 'categories': [{'measurements': [{'value': '17.44', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '17.53', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'During Week 15 and/or Week 16', 'description': 'CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values.', 'unitOfMeasure': 'percent of mean glucose level', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Daily Insulin Dose at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'classes': [{'title': 'Daily basal Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'Daily bolus Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '11.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported.', 'unitOfMeasure': 'International Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who took at least 1 dose of randomized treatment \\& analyzed as-treated (as per treatment actually received) also to whom it was unclear whether they took study medication \\& who received more than 1 study treatment during trial. Here, "number analyzed": number of participants evaluable for each specified category.'}, {'type': 'POST_HOC', 'title': 'Change From Baseline in Time (Min) of Mean Glucose Concentration Within the Target Range of 70 to 180 mg/dL, by End of Study hbA1c Levels During Week 15 and/or Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'classes': [{'title': 'End of study HbA1c <7.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105.84', 'spread': '25.64', 'groupId': 'OG000'}, {'value': '56.07', 'spread': '25.40', 'groupId': 'OG001'}]}]}, {'title': 'End of study HbA1c >=7.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.64', 'spread': '27.26', 'groupId': 'OG000'}, {'value': '31.95', 'spread': '27.57', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, during Week 15 and/or Week 16', 'description': 'Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessments. Data was reported for participants with an end of study HbA1c \\<7.5 or HbA1c \\>=7.5% over a 24 hour period.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, "number analyzed" signifies the number of participants evaluable for each specified category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting self-measured plasma glucose (SMPG) levels within the target range of 80 to 100 mg/dL.'}, {'id': 'FG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}, {'groupId': 'FG001', 'numSubjects': '318'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}, {'groupId': 'FG001', 'numSubjects': '281'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other than Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The study was conducted at 100 sites in United States. A total of 980 participants were screened between 5 May 2016 and 16 February 2017, of whom 342 were screen failures. Screen failures were mainly due to exclusion criteria met.', 'preAssignmentDetails': 'A total of 638 participants were randomized in HOE901-U300 or Lantus, stratified by baseline HbA1c (\\<8 %,\\> =8%), frequency of basal insulin injections at Visit 1 (twice vs once daily), current continuous glucose monitoring (CGM) use at Visit 1(yes/no) and mealtime insulin titration algorithm (simple titration vs carbohydrate counting).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '638', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'BG001', 'title': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '45.5', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '27.50', 'spread': '4.88', 'groupId': 'BG000'}, {'value': '27.65', 'spread': '4.92', 'groupId': 'BG001'}, {'value': '27.57', 'spread': '4.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Analysis was performed on randomized population that included any participant who had been allocated to a randomized treatment regardless of whether the treatment kit was used or not.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-02', 'size': 569009, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-19T11:30', 'hasProtocol': True}, {'date': '2017-07-07', 'size': 3371527, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-19T11:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 638}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2016-02-18', 'resultsFirstSubmitDate': '2018-06-19', 'studyFirstSubmitQcDate': '2016-02-18', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-17', 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Daily Insulin Dose at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported.'}], 'primaryOutcomes': [{'measure': 'Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM', 'timeFrame': 'During Week 15 and/or 16', 'description': 'The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia', 'timeFrame': 'Baseline up to Week 16', 'description': 'Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG \\<=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF).'}, {'measure': 'Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year', 'timeFrame': 'Baseline up to Week 16', 'description': 'Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG \\<=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF.'}, {'measure': 'Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16', 'timeFrame': 'Baseline, during Week 15 and/or Week 16', 'description': "Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16)."}, {'measure': 'Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection', 'timeFrame': 'During Week 15 and/or Week 16', 'description': "Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16)."}, {'measure': 'Coefficient of Variation (CV%) in Mean CGM Glucose', 'timeFrame': 'During Week 15 and/or Week 16', 'description': 'CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus.\n\nSecondary Objective:\n\nTo demonstrate that treatment with HOE901-U300 compared to Lantus provides:\n\n* Lower incidence rate of nocturnal symptomatic hypoglycemia;\n* Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;\n* Less variability in CGM profile.', 'detailedDescription': 'The maximum study duration per participant was to be of approximately 20 weeks that consisted of an up to a 4-week screening and CGM training period including a 1-2 week baseline (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin and including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300 and Lantus, and a 2 day post treatment follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Adult participants (male and female) with type 1 diabetes mellitus (T1DM).\n* Signed written informed consent.\n\nExclusion criteria:\n\n* Age \\<18 years or \\>70 years.\n* Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1.\n* Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1.\n* Participants who experienced none of episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association (ADA) classification) during the past month prior to screening.\n* Participants who experienced \\>1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening.\n* Participants received less than 1 year treatment with basal plus mealtime insulin.\n* Used any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo, Levemir, and Tresiba) in the past 3 months before screening.\n* Required \\>80 U/day basal insulin analogs or not on stable dose (±20% total dose) within 30 days prior to screening.\n* Used fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening.\n* Used human regular insulin as mealtime insulin within 30 days prior to screening.\n* Used an insulin pump during the last 6 months before screening.\n* History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to required treatment (e.g., laser, surgical treatment, or injectable drugs) during the study period.\n* Pregnant or breast-feeding women or planned pregnancy during the duration of the study.\n* Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever was longer prior to screening.\n* Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening.\n* Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5 point SMPG records by the end of screening.\n\nThe above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02688933', 'briefTitle': 'A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'LPS14587'}, 'secondaryIdInfos': [{'id': 'U1111-1176-0936', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HOE901-U300', 'description': 'HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting self-measured plasma glucose (SMPG) levels of 80 to 100 mg/dL, while mitigating hypoglycemia.', 'interventionNames': ['Drug: HOE901-U300 (Insulin Glargine 300 U/ml)', 'Drug: Mandated back ground therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lantus', 'description': 'Lantus (Insulin glargine, 100 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting SMPG levels of 80 to 100 mg/dL, while mitigating hypoglycemia.', 'interventionNames': ['Drug: Lantus (Insulin Glargine 100 U/ml)', 'Drug: Mandated back ground therapy']}], 'interventions': [{'name': 'HOE901-U300 (Insulin Glargine 300 U/ml)', 'type': 'DRUG', 'otherNames': ['Toujeo'], 'description': 'Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.', 'armGroupLabels': ['HOE901-U300']}, {'name': 'Lantus (Insulin Glargine 100 U/ml)', 'type': 'DRUG', 'otherNames': ['HOE901-U100'], 'description': 'Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.', 'armGroupLabels': ['Lantus']}, {'name': 'Mandated back ground therapy', 'type': 'DRUG', 'description': 'Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).', 'armGroupLabels': ['HOE901-U300', 'Lantus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840-151', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94520-2270', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-071', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-149', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-004', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-110', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-124', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-030', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-044', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-022', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-129', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-024', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '91766', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-069', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-090', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-132', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '95148', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-130', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-055', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-028', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-063', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '92780-6953', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-138', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-016', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840-039', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840-021', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840-070', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840-046', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '33124', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-072', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-133', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-137', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-049', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-076', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-023', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United 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