Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT01596504
Status:
COMPLETED
Last Update Posted:
2016-10-14
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479460', 'term': 'lixisenatide'}, {'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'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 after trial completion, the Investigator can present or publish results. The investigator provides the sponsor with a copy of the presentation or publication for review and comment at least 30 days in advance of its submission.\n\nThe sponsor can delay the submission for a period not exceeding 90 days to allow for filing a patent application or such other measures as sponsor deems appropriate to establish and 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 end of study (10 weeks) regardless of seriousness or relationship to investigational product.', 'description': "Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (the time from the first drug injection \\[included\\] up to 3 days after the last injection of drug administration \\[included\\]).", 'eventGroups': [{'id': 'EG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.', 'otherNumAtRisk': 48, 'otherNumAffected': 26, 'seriousNumAtRisk': 48, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.', 'otherNumAtRisk': 47, 'otherNumAffected': 27, 'seriousNumAtRisk': 47, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.', 'otherNumAtRisk': 47, 'otherNumAffected': 27, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 μg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.33', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-7.32', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '-8.72', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares (LS) mean difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-6.01', 'ciLowerLimit': '-7.77', 'pValueComment': 'p-values ordered(p1≤p2) as per rules:if p2≤0.05: lixisenatide superior to liraglutide (both doses);if p2\\>0.05 \\& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\\>0.05 \\& p1\\>0.025:no comparison as statistically significant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.06', 'estimateComment': 'Lixisenatide vs Liraglutide 1.2 mg', 'groupDescription': 'Analysis was performed using linear fixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \\[\\<8% and \\>=8%\\], use of metformin at screening \\[yes or no\\]) and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.', 'statisticalMethod': 'Linear fixed effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The threshold for significance at 0.05 level.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-4.61', 'ciLowerLimit': '-6.34', 'pValueComment': 'p-values ordered(p1≤p2) as per rules:if p2≤0.05:lixisenatide superior to liraglutide (both doses);if p2\\>0.05 \\& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\\>0.05 \\& p1\\>0.025: no comparison as statistically significant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'estimateComment': 'Lixisenatide vs Liraglutide 1. 8 mg', 'groupDescription': 'Analysis was performed using linear mixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \\[\\<8% and \\>=8%\\], use of metformin at screening \\[yes or no\\]), and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.', 'statisticalMethod': 'Linear fixed effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The threshold for significance at 0.05 level.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration \\[time: 0.5 hours\\]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).', 'unitOfMeasure': 'h*mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) population defined as all randomized participants, who received at least one dose of lixisenatide 20 μg, liraglutide 1.2 mg or liraglutide 1.8 mg, and had both a baseline assessment and at least one post-baseline assessment of any primary or secondary PD variables, irrespective of compliance with study protocol and procedures.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.82', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-9.09', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-10.33', 'spread': '1.25', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration \\[time: 0.5 hours\\]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).', 'unitOfMeasure': 'h*mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in PPG Excursion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.26', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-1.79', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.42', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.23', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.69', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56', 'description': 'Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with 7 point SMPG assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.16', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '0.88', 'spread': '0.39', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with C-peptide assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.56', 'spread': '19.43', 'groupId': 'OG000'}, {'value': '11.58', 'spread': '19.86', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '20.3', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.', 'unitOfMeasure': 'h*ng/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with glucagon assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.74', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56', 'description': 'HbA1C was assessed using the high performance liquid chromatography method.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed = participants with HbA1c assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '6.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 (Baseline), Day 56', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed=participants with insulin glargine dose assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '453.56', 'spread': '58.24', 'groupId': 'OG000'}, {'value': '175.31', 'spread': '58.49', 'groupId': 'OG001'}, {'value': '130.49', 'spread': '60.27', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55', 'description': 'Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry.', 'unitOfMeasure': 'minutes (min)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed=participants with gastric emptying assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 55 in Gastric Emptying Coefficient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '0.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55', 'description': 'Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying.', 'unitOfMeasure': 'coefficient (unit-less)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with gastric emptying at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.34', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '9.33', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '9.17', 'spread': '1.31', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58', 'description': 'The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with heart rate assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'title': '24-Hour Mean Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.4', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '7.7', 'groupId': 'OG002'}]}]}, {'title': '24-Hour Mean Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '4.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58', 'description': 'The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with blood pressure assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 57 in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.61', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-1.78', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '-2.42', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with body weight assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 57 in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.40', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '3.59', 'groupId': 'OG001'}, {'value': '-2.12', 'spread': '4.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed = participants with waist circumference assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lixisenatide 20 µg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'classes': [{'title': 'How hungry do you feel?', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'How satisfied do you feel?', 'categories': [{'measurements': [{'value': '4.5', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'How full do you feel?', 'categories': [{'measurements': [{'value': '4.9', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '13.8', 'groupId': 'OG002'}]}]}, {'title': 'How much do you think you can eat?', 'categories': [{'measurements': [{'value': '-6.4', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '15.7', 'groupId': 'OG001'}, {'value': '-7.2', 'spread': '12.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population. Number of participants analyzed=participants with appetite perception assessment at specified time-points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lixisenatide 20 μg', 'description': 'Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'FG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'FG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': "Participant's Private Reason", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 8 centers in Germany between 22 May 2012 to 25 July 2013.', 'preAssignmentDetails': 'A total of 236 participants were screened and 142 participants were randomized and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lixisenatide 20 μg', 'description': 'Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'BG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'BG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '61.9', 'spread': '8.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'title': 'Caucasian/White', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Metformin Use at Screening', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '90.56', 'spread': '13.09', 'groupId': 'BG000'}, {'value': '91.62', 'spread': '13.92', 'groupId': 'BG001'}, {'value': '92.92', 'spread': '15.33', 'groupId': 'BG002'}, {'value': '91.69', 'spread': '14.07', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.68', 'spread': '4.34', 'groupId': 'BG000'}, {'value': '30.52', 'spread': '4.01', 'groupId': 'BG001'}, {'value': '31.17', 'spread': '4.34', 'groupId': 'BG002'}, {'value': '30.79', 'spread': '4.22', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '(kg/m²)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c at Screening (Day -7)', 'classes': [{'categories': [{'measurements': [{'value': '7.22', 'spread': '0.48', 'groupId': 'BG000'}, {'value': '7.19', 'spread': '0.53', 'groupId': 'BG001'}, {'value': '7.33', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '7.25', 'spread': '0.50', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2015-04-21', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2012-05-07', 'dispFirstSubmitQcDate': '2015-04-21', 'resultsFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2012-05-09', 'dispFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-22', 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours', 'timeFrame': '0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration \\[time: 0.5 hours\\]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours', 'timeFrame': '0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration \\[time: 0.5 hours\\]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).'}, {'measure': 'Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56', 'timeFrame': 'Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast.'}, {'measure': 'Change From Baseline to Day 56 in PPG Excursion', 'timeFrame': '0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.'}, {'measure': 'Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)', 'timeFrame': '0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56', 'description': 'Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline.'}, {'measure': 'Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)', 'timeFrame': 'Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56', 'description': 'Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated.'}, {'measure': 'Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours', 'timeFrame': '0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.'}, {'measure': 'Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours', 'timeFrame': '0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.'}, {'measure': 'Change From Baseline to Day 56 in HbA1c', 'timeFrame': 'Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56', 'description': 'HbA1C was assessed using the high performance liquid chromatography method.'}, {'measure': 'Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose', 'timeFrame': 'Day -7 (Baseline), Day 56'}, {'measure': 'Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)', 'timeFrame': '0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55', 'description': 'Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry.'}, {'measure': 'Change From Baseline to Day 55 in Gastric Emptying Coefficient', 'timeFrame': '0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55', 'description': 'Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying.'}, {'measure': 'Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate', 'timeFrame': 'Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58', 'description': 'The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.'}, {'measure': 'Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure', 'timeFrame': 'Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58', 'description': 'The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.'}, {'measure': 'Change From Baseline to Day 57 in Body Weight', 'timeFrame': '0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57'}, {'measure': 'Change From Baseline to Day 57 in Waist Circumference', 'timeFrame': '0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57'}, {'measure': 'Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast', 'timeFrame': '0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56', 'description': 'Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25887358', 'type': 'RESULT', 'citation': 'Meier JJ, Rosenstock J, Hincelin-Mery A, Roy-Duval C, Delfolie A, Coester HV, Menge BA, Forst T, Kapitza C. Contrasting Effects of Lixisenatide and Liraglutide on Postprandial Glycemic Control, Gastric Emptying, and Safety Parameters in Patients With Type 2 Diabetes on Optimized Insulin Glargine With or Without Metformin: A Randomized, Open-Label Trial. Diabetes Care. 2015 Jul;38(7):1263-73. doi: 10.2337/dc14-1984. Epub 2015 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n\\- To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after a standardized breakfast at the end of a 8-week treatment period in participants with type 2 diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin).\n\nSecondary Objectives:\n\n* To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8 mg QD after an 8-week treatment period in participants with T2DM not adequately controlled with insulin glargine (± metformin) on:\n\n * Post-prandial C-peptide, glucagon and appetite perceptions after a standardized breakfast,\n * Appetite perceptions after standardized dinner,\n * Gastric emptying after a standardized labelled test meal,\n * Fasting plasma glucose, 24-hour plasma glucose profile,\n * Glycosylated hemoglobin (HbA1c),\n * Insulin glargine dose,\n * 7-point self monitored plasma glucose (SMPG),\n * Body weight and waist circumference,\n * 24-hour heart rate and blood pressure,\n* To assess lixisenatide and liraglutide safety and tolerability as add on treatment to insulin glargine (± metformin).', 'detailedDescription': 'Up to 2-week screening period\n\n* A run-in period of 12 weeks at maximum including a forced titration with insulin glargine up to 11 weeks and 1 baseline pharmacodynamic assessment week\n* A 8-week treatment(s) period(s) up to Day 57\n* Follow-up: 7 ±2 days after the last treatment day\n* Total study duration approximately 14 weeks up to 23 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Participants with T2DM diagnosed at least 1 year before the screening visit.\n* Treatment with neutral protamine hagedorn (NPH) or insulin glargine for at least 3 months and at a stable dose (±20%) of at least 10 IU/day (for at least 2 months prior to screening) alone or combined with a stable dose of metformin with or without dipeptidyl peptidase 4 (DPP-4) inhibitor or sulfonylurea.\n* Glycosylated hemoglobin (HbA1c) ≥6.5 and ≤9.5%.\n* Body mass index (BMI) between 20 and 40 kg/m\\^2.\n\nExclusion criteria:\n\n* Pregnant women or breastfeeding women.\n* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening.\n* Any previous treatment with lixisenatide or participation in a previous study with lixisenatide (AVE0010), and any previous treatment with liraglutide stopped for safety concern or lack of efficacy.\n* Allergic reaction to any glucagon-like peptide-1 (GLP-1) agonist in the past (eg, exenatide) or to metacresol.\n* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.\n* Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01596504', 'briefTitle': 'Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin', 'orgStudyIdInfo': {'id': 'PDY12625'}, 'secondaryIdInfos': [{'id': '2012-000027-40', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1124-1364', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lixisenatide 20 μg', 'description': 'Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks under fasted conditions, on top of insulin glargine with or without metformin.', 'interventionNames': ['Drug: Lixisenatide (AVE0010)', 'Drug: Insulin Glargine', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liraglutide 1.2 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks under fasted conditions, on top of insulin glargine with or without metformin.', 'interventionNames': ['Drug: Liraglutide', 'Drug: Insulin Glargine', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liraglutide 1.8 mg', 'description': 'Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks under fasted conditions, on top of insulin glargine with or without metformin.', 'interventionNames': ['Drug: Liraglutide', 'Drug: Insulin Glargine', 'Drug: Metformin']}], 'interventions': [{'name': 'Lixisenatide (AVE0010)', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution for injection self-administered with a pen-like injector (OptiClik®).\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['Lixisenatide 20 μg']}, {'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza®'], 'description': 'Pharmaceutical form:solution for injection\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['Liraglutide 1.2 mg', 'Liraglutide 1.8 mg']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'otherNames': ['Lantus® SoloSTAR®'], 'description': 'Doses to be adjusted to maintain a fasting self-measured plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL)', 'armGroupLabels': ['Liraglutide 1.2 mg', 'Liraglutide 1.8 mg', 'Lixisenatide 20 μg']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'If previously taken metformin to be continued at stable dose throughout the study', 'armGroupLabels': ['Liraglutide 1.2 mg', 'Liraglutide 1.8 mg', 'Lixisenatide 20 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site Number 276008', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site Number 276006', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Investigational Site Number 276004', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Investigational Site Number 276002', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '41061', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Investigational Site Number 276005', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '80636', 'city': 'München', 'country': 'Germany', 'facility': 'Investigational Site Number 276007', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '89231', 'city': 'Neu-Ulm', 'country': 'Germany', 'facility': 'Investigational Site Number 276003', 'geoPoint': {'lat': 48.39279, 'lon': 10.01112}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Investigational Site Number 276001', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}