Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 10:35 PM
Study NCT ID:
NCT00917267
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
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': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, '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 of 2 mg exenatide, once a week', 'otherNumAtRisk': 340, 'otherNumAffected': 131, 'seriousNumAtRisk': 340, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)', 'otherNumAtRisk': 338, 'otherNumAffected': 150, 'seriousNumAtRisk': 338, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood calcitonin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cerebral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia haemophilus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline to Week 26.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'MMRM analysis of covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects. Power: 306 patients per treatment group provides approximately 98% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is \\<0; noninferiority concluded if upper limit is \\<0.4%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HbA1c from baseline to Week 26.', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: Randomized patients received at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c Targets <=7% at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Percentage of patients achieving HbA1c target \\<=7% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which country and background OAD served as the stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of patients achieving HbA1c \\<=7% at Week 26 (for patients with HbA1c \\>7% at baseline).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with baseline HbA1c \\> target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}, {'value': '15.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Percentage of patients achieving HbA1c target \\<=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD served as the stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of patients achieving HbA1c \\<=6.5% at Week 26 (for patients with HbA1c \\>6.5% at baseline).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with baseline HbA1c \\> target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Glucose (FSG) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.57', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '-23.90', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.67', 'ciLowerLimit': '-22.50', 'ciUpperLimit': '-10.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.97', 'groupDescription': 'MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in FSG from baseline to Week 26.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (BW) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.63', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-2.45', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in BW from baseline to Week 26.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol (TC) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.41', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-8.10', 'spread': '2.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.609', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.31', 'ciLowerLimit': '-6.33', 'ciUpperLimit': '3.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.56', 'groupDescription': 'MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in TC from baseline to Week 26.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change in High-Density Lipoprotein (HDL) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.476', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '1.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HDL from baseline to Week 26.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Ratio of Triglycerides (TG) at Week 26 to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.807', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometic Least Squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'groupDescription': 'TG data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM ANCOVA model with treatment, baseline TG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-5.33', 'spread': '15.99', 'groupId': 'OG000'}, {'value': '-5.22', 'spread': '16.23', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-1.47', 'spread': '9.52', 'groupId': 'OG000'}, {'value': '-2.24', 'spread': '9.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was not imputed.'}, {'type': 'SECONDARY', 'title': 'Assessment of Event Rate of Treatment-emergent Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly With SU Use at Screening', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week and with SU use at Screening'}, {'id': 'OG001', 'title': 'Exenatide Twice Daily With SU Use at Screening', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and with SU use at Screening'}, {'id': 'OG002', 'title': 'Exenatide Once Weekly Without SU Use at Screening', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week and without SU use at Screening'}, {'id': 'OG003', 'title': 'Exenatide Twice Daily Without SU Use at Screening', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and without SU use at Screening'}], 'classes': [{'title': 'Major Hypoglycemia', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.007', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG003'}]}]}, {'title': 'Minor Hypoglycemia', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.180', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.027', 'groupId': 'OG002'}, {'value': '0.11', 'spread': '0.113', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26', 'description': 'Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick 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 post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.', 'unitOfMeasure': 'events per subject-year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'FG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '346'}, {'groupId': 'FG001', 'numSubjects': '345'}]}, {'type': 'Intent to Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}, {'groupId': 'FG001', 'numSubjects': '338'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '266'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '79'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy-Loss of Glucose Control', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '678', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide Once Weekly', 'description': 'Subcutaneous injection of 2 mg exenatide, once a week'}, {'id': 'BG001', 'title': 'Exenatide Twice Daily', 'description': 'Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)'}, {'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': '275', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '10.59', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '9.99', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '10.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.04', 'groupId': 'BG000'}, {'value': '8.7', 'spread': '1.03', 'groupId': 'BG001'}, {'value': '8.7', 'spread': '1.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'spread': '12.44', 'groupId': 'BG000'}, {'value': '70.4', 'spread': '12.09', 'groupId': 'BG001'}, {'value': '70.0', 'spread': '12.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Background Oral Antidiabetic Agent (OAD)', 'classes': [{'title': 'Metformin (MET)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'MET+Sulfonylurea (SU)', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}]}, {'title': 'MET+SU+Thiazolidinedione (TZD)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'MET+TZD', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'SU', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'SU+TZD', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'TZD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', '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': 691}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'dispFirstSubmitDate': '2011-06-17', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2009-06-08', 'dispFirstSubmitQcDate': '2011-06-17', 'resultsFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2009-06-08', 'dispFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-28', 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline to Week 26.', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HbA1c from baseline to Week 26.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Achieving HbA1c Targets <=7% at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of patients achieving HbA1c \\<=7% at Week 26 (for patients with HbA1c \\>7% at baseline).'}, {'measure': 'Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of patients achieving HbA1c \\<=6.5% at Week 26 (for patients with HbA1c \\>6.5% at baseline).'}, {'measure': 'Change in Fasting Serum Glucose (FSG) From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in FSG from baseline to Week 26.'}, {'measure': 'Change in Body Weight (BW) From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in BW from baseline to Week 26.'}, {'measure': 'Change in Total Cholesterol (TC) From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in TC from baseline to Week 26.'}, {'measure': 'Change in High-Density Lipoprotein (HDL) From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HDL from baseline to Week 26.'}, {'measure': 'Ratio of Triglycerides (TG) at Week 26 to Baseline', 'timeFrame': 'Baseline, Week 26', 'description': 'Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.'}, {'measure': 'Change in Blood Pressure From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.'}, {'measure': 'Assessment of Event Rate of Treatment-emergent Hypoglycemic Events', 'timeFrame': 'Baseline to Week 26', 'description': 'Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick 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 post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'exenatide', 'once weekly', 'Byetta', 'Amylin', 'Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24843650', 'type': 'DERIVED', 'citation': 'Onishi Y, Koshiyama H, Imaoka T, Haber H, Scism-Bacon J, Boardman MK. Safety of exenatide once weekly for 52 weeks in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Mar 18;4(2):182-9. doi: 10.1111/jdi.12000. Epub 2012 Oct 22.'}, {'pmid': '24843631', 'type': 'DERIVED', 'citation': 'Ji L, Onishi Y, Ahn CW, Agarwal P, Chou CW, Haber H, Guerrettaz K, Boardman MK. Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Jan 29;4(1):53-61. doi: 10.1111/j.2040-1124.2012.00238.x. Epub 2012 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed with type 2 diabetes.\n* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.\n* Have a body mass index (BMI) of \\>21 kg/m2 and \\<35 kg/m2, inclusive.\n* Have a history of stable body weight (not varying by \\>5% for at least 90 days prior to study start).\n* Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.\n\nExclusion Criteria:\n\n* Have any contraindication for the OAD(s) that they use.\n* Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.\n* Have received chronic \\>14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.\n* Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.\n* Have been treated for \\>2 weeks with any of the following excluded medications within 90 days prior to study start:\n\n * Insulin\n * Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)\n * Pramlintide acetate\n * Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.\n* Have had prior exposure to exenatide\n* Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.\n* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.\n* Are currently enrolled in any other clinical study.'}, 'identificationModule': {'nctId': 'NCT00917267', 'briefTitle': 'A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications', 'orgStudyIdInfo': {'id': 'H8O-MC-GWCK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 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