Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT00935532
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2009-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Peter Ohman, Medical Science Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.', 'otherNumAtRisk': 215, 'otherNumAffected': 145, 'seriousNumAtRisk': 215, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day', 'otherNumAtRisk': 212, 'otherNumAffected': 65, 'seriousNumAtRisk': 212, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diverticulitis intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline to Endpoint (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '-0.26', 'pValueComment': 'No adjustments for multiplicity will be performed', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority of exenatide QW to insulin glargine with respect to change in HbA1c was to be concluded if the upper limit of the 95% confidence interval (CI) for the treatment difference was less than 0.4%. Change in HbA1c from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, baseline HbA1c stratum (\\<8.5%, \\>=8.5%), background OAD, and presence/absence of pretreatment with SU as factors and baseline HbA1c as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HbA1c from baseline to endpoint (Week 26).', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical analysis of this study was performed for the full analysis set (FAS). FAS consisted of randomized patients who received administration of the study drug at least once and had measurement values after administration. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving HbA1c<=7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Percentage of subjects achieving HbA1c\\<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of subjects achieving HbA1c \\<=7.0% (for subjects with HbA1c \\>7% at baseline)', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Only subjects with baseline HbA1c \\> target were included in calculation. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving HbA1c<=6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Percentage of subjects achieving HbA1c\\<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of subjects achieving HbA1c \\<=6.5% (for subjects with HbA1c \\>6.5% at baseline)', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Only subjects with baseline HbA1c \\> target were included in calculation. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.09', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-40.82', 'spread': '2.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.28', 'ciLowerLimit': '-11.62', 'ciUpperLimit': '1.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.23', 'groupDescription': 'Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in FSG (centralized measurement) from baseline to endpoint (Week 26)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline to Endpoint (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.01', 'ciLowerLimit': '-2.46', 'ciUpperLimit': '-1.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Body Weight from baseline to endpoint (Week 26)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol From Baseline to Endpoint (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.21', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-6.32', 'spread': '1.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.89', 'ciLowerLimit': '-12.33', 'ciUpperLimit': '-3.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.26', 'groupDescription': 'Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Total Cholesterol from baseline to endpoint (Week 26)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-1.64', 'ciUpperLimit': '1.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': 'Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HDL-C from baseline to endpoint (Week 26)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.990', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'groupDescription': 'Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure From Baseline to Endpoint (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '14.04', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '14.29', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '9.25', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '8.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Blood Pressure from baseline to endpoint (Week 26)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26', 'description': 'Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\\*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.', 'unitOfMeasure': 'events per subject-year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population.'}, {'type': 'SECONDARY', 'title': 'Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26', 'description': 'Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose \\<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\\*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.', 'unitOfMeasure': 'events per subject-year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'FG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '212'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Loss Glucose Control', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '427', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection, 2.0mg, once a week.'}, {'id': 'BG001', 'title': 'Insulin Glargine', 'description': 'Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '10.44', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '11.16', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '10.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.51', 'spread': '0.823', 'groupId': 'BG000'}, {'value': '8.50', 'spread': '0.791', 'groupId': 'BG001'}, {'value': '8.50', 'spread': '0.806', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '69.95', 'spread': '13.246', 'groupId': 'BG000'}, {'value': '71.03', 'spread': '13.932', 'groupId': 'BG001'}, {'value': '70.49', 'spread': '13.586', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Background Oral Antidiabetic Agent (OAD)', 'classes': [{'title': 'Biguanide (BG)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}, {'title': 'BG+Thiazolidine Derivative (TZD)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 427}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2011-06-17', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2009-07-08', 'dispFirstSubmitQcDate': '2011-06-17', 'resultsFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2009-07-08', 'dispFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-24', 'studyFirstPostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline to Endpoint (Week 26)', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HbA1c from baseline to endpoint (Week 26).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Achieving HbA1c<=7%', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of subjects achieving HbA1c \\<=7.0% (for subjects with HbA1c \\>7% at baseline)'}, {'measure': 'Percentage of Subjects Achieving HbA1c<=6.5%', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of subjects achieving HbA1c \\<=6.5% (for subjects with HbA1c \\>6.5% at baseline)'}, {'measure': 'Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in FSG (centralized measurement) from baseline to endpoint (Week 26)'}, {'measure': 'Change in Body Weight From Baseline to Endpoint (Week 26)', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Body Weight from baseline to endpoint (Week 26)'}, {'measure': 'Change in Total Cholesterol From Baseline to Endpoint (Week 26)', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Total Cholesterol from baseline to endpoint (Week 26)'}, {'measure': 'Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HDL-C from baseline to endpoint (Week 26)'}, {'measure': 'Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline', 'timeFrame': 'Baseline, Week 26', 'description': 'Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.'}, {'measure': 'Change in Blood Pressure From Baseline to Endpoint (Week 26)', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Blood Pressure from baseline to endpoint (Week 26)'}, {'measure': 'Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events', 'timeFrame': 'Baseline to Week 26', 'description': 'Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\\*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.'}, {'measure': 'Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events', 'timeFrame': 'Baseline to Week 26', 'description': 'Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose \\<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\\*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '32306296', 'type': 'DERIVED', 'citation': 'Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.'}, {'pmid': '22884767', 'type': 'DERIVED', 'citation': 'Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012 Sep;34(9):1892-908.e1. doi: 10.1016/j.clinthera.2012.07.007. Epub 2012 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* present with type 2 diabetes mellitus\n* HbA1c between 7.1% and 11.0% inclusive\n* body mass index (BMI) of \\>18kg/m2 and \\<35kg/m2, inclusive\n* treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start\n\nExclusion Criteria:\n\n* Have received chronic (\\>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.\n* Have been treated with drugs that promote weight loss within 90 days prior to study start.\n* Have been treated with drugs that directly affect gastrointestinal motility for \\> 21 consecutive days within 90 days prior to study start.\n* Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).\n* Have been treated for \\>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs\n* Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.\n* Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.\n* Have donated blood within 30 days prior to study start.'}, 'identificationModule': {'nctId': 'NCT00935532', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)', 'orgStudyIdInfo': {'id': 'H8O-JE-GWBX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exenatide once weekly', 'interventionNames': ['Drug: exenatide once weekly']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'insulin glargine', 'interventionNames': ['Drug: insulin glargine']}], 'interventions': [{'name': 'exenatide once weekly', 'type': 'DRUG', 'description': 'subcutaneous injection, 2.0mg, once a week;', 'armGroupLabels': ['exenatide once weekly']}, {'name': 'insulin glargine', 'type': 'DRUG', 'otherNames': ['insulin glargine-Lantus'], 'description': 'subcutaneous injection, titrated to achieve fasting serum glucose target, once a day', 'armGroupLabels': ['insulin glargine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aomori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 40.81667, 'lon': 140.73333}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Ehime', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gunma', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 131.03333}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Nagano', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Nara', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}], 'overallOfficials': [{'name': 'Chief Medical Officer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}