Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-09 @ 12:09 PM
Study NCT ID:
NCT02058160
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2014-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'C479460', 'term': 'lixisenatide'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.', 'description': "Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.", 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).', 'otherNumAtRisk': 365, 'otherNumAffected': 81, 'seriousNumAtRisk': 365, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 210 days).', 'otherNumAtRisk': 365, 'otherNumAffected': 42, 'seriousNumAtRisk': 365, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Benign gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': "Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.13', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.055', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.633', 'ciUpperLimit': '-0.397', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Insulin Glargine/Lixisenatide FRC vs Insulin Glargine', 'groupDescription': 'Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\\<8.0, ≥8.0%), randomization strata of metformin use at screening, visits, treatment-by-visit interaction and country as fixed effects and baseline HbA1c value-by-visit interaction as covariates. A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 30 value.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'title': 'HbA1c <7.0%', 'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c ≤ 6.5%', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '14.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.52', 'ciLowerLimit': '18.94', 'ciUpperLimit': '32.10', 'pValueComment': 'Threshold for significance at 0.05 level.', 'estimateComment': 'HbA1c \\<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine', 'groupDescription': 'HbA1c \\<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.\n\nAnalysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.76', 'ciLowerLimit': '13.90', 'ciUpperLimit': '25.62', 'estimateComment': 'HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine', 'groupDescription': 'HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.\n\nAnalysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 30', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.285', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.274', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.43', 'ciLowerLimit': '-3.925', 'ciUpperLimit': '-2.939', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.251', 'estimateComment': 'Insulin Glargine/Lixisenatide FRC vs Insulin Glargine', 'groupDescription': 'Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\\<8.0, ≥8.0%), randomization strata of metformin use at screening and country as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': 'Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period. Missing data was imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.178', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.37', 'ciLowerLimit': '-1.808', 'ciUpperLimit': '-0.93', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.224', 'estimateComment': 'Insulin Glargine/Lixisenatide FRC vs Insulin Glargine', 'groupDescription': 'Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline body weight value-by-visit interaction as covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in body weight was calculated by subtracting baseline value from Week 30 value.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.'}, {'type': 'SECONDARY', 'title': 'Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.154', 'ciUpperLimit': '-0.64', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.131', 'estimateComment': 'Insulin Glargine/Lixisenatide FRC vs Insulin Glargine', 'groupDescription': 'Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline average SMPG value-by-visit interaction as covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': 'Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline 7-point SMPG assessment during study period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '13.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.82', 'ciLowerLimit': '14.98', 'ciUpperLimit': '26.66', 'pValueComment': 'Threshold for significance at 0.05 level.', 'estimateComment': 'Insulin Glargine/Lixisenatide FRC vs Insulin Glargine', 'groupDescription': 'Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\\<8.0%, ≥8.0%) and randomization strata of metformin use at screening.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 30', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Change in Daily Insulin Glargine Dose From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.64', 'spread': '0.601', 'groupId': 'OG000'}, {'value': '10.89', 'spread': '0.587', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7362', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-1.762', 'ciUpperLimit': '1.246', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.766', 'estimateComment': 'Insulin Glargine/Lixisenatide FRC vs Insulin Glargine', 'groupDescription': 'Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline daily insulin glargine dose-by-visit interaction as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'unitOfMeasure': 'Units (U)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. The analysis included scheduled measurements obtained up to the date of last injection of IMP. Here, number of participants analyzed= participants with insulin glargine dose assessment during study period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 30', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Change in FPG From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.138', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 30 value.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline FPG assessment during study period.'}, {'type': 'SECONDARY', 'title': 'Change in 2-hour PPG From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.72', 'spread': '0.322', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in PPG was calculated by subtracting baseline value from Week 30 value.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline PPG assessment during study period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 30', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 30', 'description': 'Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG \\>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG \\>200 mg/dL (11.1 mmol/L) or HbA1c \\>8%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'groupId': 'OG000'}, {'value': '4.22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).', 'unitOfMeasure': 'events per subject-year', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Documented Symptomatic Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '42.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Severe Symptomatic Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])', 'description': 'Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.'}, {'id': 'FG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '367'}, {'groupId': 'FG001', 'numSubjects': '369'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '365'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}, {'groupId': 'FG001', 'numSubjects': '355'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The study was conducted at 236 centers in 18 countries. A total of 1930 participants were screened between January 27, 2014 and October 15, 2014. 912 participants were not eligible for run-in-phase mainly due to glycated hemoglobin (HbA1c) value being out of the protocol defined range.', 'preAssignmentDetails': 'After screening phase, 1018 participants entered 6 week run-in phase during which participants were switched (if necessary) to insulin glargine and dose was titrated/stabilized, any oral anti-diabetic drugs (OAD) other than metformin were stopped. 282 participants were run-in failures and 736 were randomized in 1:1(FRC:insulin glargine arms) ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'BG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.6', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '60.3', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '675', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Oriental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity', 'classes': [{'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'OAD Use', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '350', 'groupId': 'BG001'}, {'value': '699', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'OAD Use at Screening by Class', 'classes': [{'title': 'Metformin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}]}, {'title': 'Sulfonylurea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Sodium glucose co-transporter 2 (SGLT-2) inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Dipeptidyl-peptidase 4 (DPP-4) inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Glinide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Metformin + Sulfonylurea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}]}, {'title': 'Metformin + DPP-4 inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Metfomrin + Glinide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Sulfonylurea + DPP-4 inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.33', 'spread': '4.25', 'groupId': 'BG000'}, {'value': '30.96', 'spread': '4.15', 'groupId': 'BG001'}, {'value': '31.14', 'spread': '4.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '735', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.02', 'spread': '6.64', 'groupId': 'BG000'}, {'value': '12.13', 'spread': '6.85', 'groupId': 'BG001'}, {'value': '12.08', 'spread': '6.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants with available data for this baseline measure were included in the analysis.'}, {'title': 'Daily Dose of Metformin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2082.8', 'spread': '499.2', 'groupId': 'BG000'}, {'value': '2042.0', 'spread': '455.9', 'groupId': 'BG001'}, {'value': '2062.4', 'spread': '478.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants with available data for this baseline measure were included in the analysis.'}, {'title': 'Screening Glycated Hemoglobin (HbA1c)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.51', 'spread': '0.65', 'groupId': 'BG000'}, {'value': '8.54', 'spread': '0.67', 'groupId': 'BG001'}, {'value': '8.53', 'spread': '0.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HbA1c', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.07', 'spread': '0.68', 'groupId': 'BG000'}, {'value': '8.08', 'spread': '0.73', 'groupId': 'BG001'}, {'value': '8.08', 'spread': '0.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.34', 'spread': '1.95', 'groupId': 'BG000'}, {'value': '7.36', 'spread': '2.12', 'groupId': 'BG001'}, {'value': '7.35', 'spread': '2.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 736}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2016-07-01', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2014-02-06', 'dispFirstSubmitQcDate': '2016-07-01', 'resultsFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2014-02-06', 'dispFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-16', 'studyFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 30 value.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30', 'timeFrame': 'Week 30'}, {'measure': 'Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30', 'description': 'Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value.'}, {'measure': 'Change in Body Weight From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in body weight was calculated by subtracting baseline value from Week 30 value.'}, {'measure': 'Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30', 'description': 'Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.'}, {'measure': 'Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30', 'timeFrame': 'Week 30'}, {'measure': 'Change in Daily Insulin Glargine Dose From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30'}, {'measure': 'Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period', 'timeFrame': 'Baseline up to Week 30', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).'}, {'measure': 'Change in FPG From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 30 value.'}, {'measure': 'Change in 2-hour PPG From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in PPG was calculated by subtracting baseline value from Week 30 value.'}, {'measure': 'Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period', 'timeFrame': 'Baseline up to Week 30', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).'}, {'measure': 'Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period', 'timeFrame': 'Baseline up to Week 30', 'description': 'Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG \\>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG \\>200 mg/dL (11.1 mmol/L) or HbA1c \\>8%.'}, {'measure': 'Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year', 'timeFrame': 'First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).'}, {'measure': 'Percentage of Participants With Documented Symptomatic Hypoglycemia', 'timeFrame': 'First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).'}, {'measure': 'Percentage of Participants With Severe Symptomatic Hypoglycemia', 'timeFrame': 'First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])', 'description': 'Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27650977', 'type': 'RESULT', 'citation': 'Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, Gonzalez-Galvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM; LixiLan-L Trial Investigators. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Diabetes Care. 2016 Nov;39(11):1972-1980. doi: 10.2337/dc16-1495. Epub 2016 Sep 20.'}, {'pmid': '31848983', 'type': 'DERIVED', 'citation': 'Tabak AG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.'}, {'pmid': '31359368', 'type': 'DERIVED', 'citation': 'Blonde L, Bailey TS, Chao J, Dex TA, Frias JP, Meneghini LF, Roberts M, Aroda VR. Clinical Characteristics and Glycemic Outcomes of Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial. Adv Ther. 2019 Sep;36(9):2310-2326. doi: 10.1007/s12325-019-01033-1. Epub 2019 Jul 29.'}, {'pmid': '31114694', 'type': 'DERIVED', 'citation': 'Dailey G, Bajaj HS, Dex T, Groleau M, Stager W, Vinik A. Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world. BMJ Open Diabetes Res Care. 2019 Mar 21;7(1):e000581. doi: 10.1136/bmjdrc-2018-000581. eCollection 2019.'}, {'pmid': '30550345', 'type': 'DERIVED', 'citation': 'Schmider W, Belder R, Lee M, Niemoeller E, Souhami E, Frias JP. Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes. Curr Med Res Opin. 2019 Jun;35(6):1081-1089. doi: 10.1080/03007995.2018.1558852. Epub 2019 Jan 11.'}, {'pmid': '30218434', 'type': 'DERIVED', 'citation': 'Zisman A, Dex T, Roberts M, Saremi A, Chao J, Aroda VR. Bedtime-to-Morning Glucose Difference and iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of LixiLan-L. Diabetes Ther. 2018 Oct;9(5):2155-2162. doi: 10.1007/s13300-018-0507-0. Epub 2018 Sep 14.'}, {'pmid': '29974618', 'type': 'DERIVED', 'citation': 'Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.'}, {'pmid': '29923298', 'type': 'DERIVED', 'citation': 'Trujillo JM, Roberts M, Dex T, Chao J, White J, LaSalle J. Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone. Diabetes Obes Metab. 2018 Nov;20(11):2690-2694. doi: 10.1111/dom.13444. Epub 2018 Aug 21.'}, {'pmid': '29143919', 'type': 'DERIVED', 'citation': 'Niemoeller E, Souhami E, Wu Y, Jensen KH. iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. Diabetes Ther. 2018 Feb;9(1):373-382. doi: 10.1007/s13300-017-0336-6. Epub 2017 Nov 16.'}, {'pmid': '28386990', 'type': 'DERIVED', 'citation': 'Wysham C, Bonadonna RC, Aroda VR, Puig Domingo M, Kapitza C, Stager W, Yu C, Niemoeller E, Souhami E, Bergenstal RM; LixiLan-L trial investigators. Consistent findings in glycaemic control, body weight and hypoglycaemia with iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) vs insulin glargine across baseline HbA1c, BMI and diabetes duration categories in the LixiLan-L trial. Diabetes Obes Metab. 2017 Oct;19(10):1408-1415. doi: 10.1111/dom.12961. Epub 2017 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.\n\nSecondary Objective:\n\nTo compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.', 'detailedDescription': 'Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.\n* Treatment with basal insulin for at least 6 months before the screening visit.\n* Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.\n* Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.\n* For participants receiving basal insulin and 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs could be 1 to 2 out of:\n\n * metformin (more than or equal to 1500 mg/day or maximal tolerated dose),\n * a sulfonylurea,\n * a glinide,\n * a dipeptidyl-peptidase-4 inhibitor,\n * a sodium glucose co-transporter 2 inhibitor,\n* Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit.\n* Signed written informed consent.\n\nExclusion criteria:\n\n* Age under legal age of adulthood at screening visit.\n* HbA1c at screening visit less than 7.5% or above 10%.\n* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.\n* Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening.\n* Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed.\n* History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy.\n* Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had previously received lixisenatide.\n* Use of weight loss drugs within 3 months prior to screening visit.\n* Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.\n* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.\n* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).\n* Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.\n* At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m\\^2.\n* At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.\n* At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.\n* At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).\n* Any contraindication to metformin use, according to local labeling, if the participant was taking metformin.\n* Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin.\n\nExclusion criteria for randomization:\n\n* HbA1c less than 7% or above 10% .\n* Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).\n* Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).\n* Amylase and/or lipase more than 3 ULN .\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02058160', 'acronym': 'LixiLan-L', 'briefTitle': 'Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)', 'orgStudyIdInfo': {'id': 'EFC12405'}, 'secondaryIdInfos': [{'id': '2013-003132-79', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1148-4351', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC once daily (QD) for 30 weeks. Dose individually adjusted.', 'interventionNames': ['Drug: Insulin glargine/lixisenatide (HOE901/AVE0010)', 'Drug: Metformin (Background Drug)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin glargine', 'description': 'Insulin glargine 100 U/mL QD for 30 weeks. Dose individually adjusted.', 'interventionNames': ['Drug: Insulin glargine (HOE901)', 'Drug: Metformin (Background Drug)']}], 'interventions': [{'name': 'Insulin glargine/lixisenatide (HOE901/AVE0010)', 'type': 'DRUG', 'description': "Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization.\n\nDose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg.", 'armGroupLabels': ['Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)']}, {'name': 'Insulin glargine (HOE901)', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'Insulin glargine was self-administered QD by SC injection at approximately the same time every day.\n\nAfter screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).', 'armGroupLabels': ['Insulin glargine']}, {'name': 'Metformin (Background Drug)', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet; Route of administration: Oral administration', 'armGroupLabels': ['Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'Insulin glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840607', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840570', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840562', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840577', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840517', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840537', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90201', 'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840568', 'geoPoint': {'lat': 33.96529, 'lon': -118.15146}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840550', 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