Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-26 @ 6:55 PM
Study NCT ID:
NCT00641056
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2008-03-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
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': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.', 'otherNumAtRisk': 233, 'otherNumAffected': 100, 'seriousNumAtRisk': 233, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.', 'otherNumAtRisk': 223, 'otherNumAffected': 52, 'seriousNumAtRisk': 223, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedematous pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Viral pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vitrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colon polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peripheral nerve transposition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.47', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '-0.03', 'pValueComment': 'No adjustments for multiplicity were performed', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'Mixed-model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects. Superiority of exenatide once weekly to insulin glargine is concluded if the upper limit of the 95% confidence interval for the treatment difference \\[exenatide once weekly-insulin glargine\\]\\<0; noninferiority is concluded if this upper limit\\<0.3%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Power: 205 patients per treatment group would provide approximately 92% 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%.'}], '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: All randomized patients who had taken 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 <=7.0% at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000'}, {'value': '54.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'No adjustments for multiplicity were performed', 'groupDescription': 'Percentage of patients achieving HbA1c \\<=7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and country 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 \\<=7.0% at Week 26 (for patients with HbA1c \\>7% at baseline)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only patients with baseline HbA1c \\> 7% 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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c <=6.5% at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}, {'value': '28.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'No adjustments for multiplicity were performed', 'groupDescription': 'Percentage of patients achieving HbA1c \\<=6.5% at Week 26 were compared between treatments using a CMH test, in which background OAD and country 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 \\> 6.5% 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.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Glucose (FSG) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.13', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-2.76', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.00', 'pValueComment': 'No adjustments for multiplicity were performed', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'MMRM ANCOVA with change in FSG as the dependent variable; treatment, baseline FSG, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; 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 (mmol/L) from Baseline to Week 26', 'unitOfMeasure': 'mmol/L', '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': '207', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.63', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.05', 'ciLowerLimit': '-4.57', 'ciUpperLimit': '-3.52', 'pValueComment': 'No adjustments for multiplicity were performed', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'MMRM ANCOVA with change in BW as the dependent variable; treatment, baseline BW, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; 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 (kg) 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 From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.292', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.06', 'pValueComment': 'No adjustments for multiplicity were performed', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'MMRM ANCOVA with change in total cholesterol as the dependent variable; treatment, baseline total cholesterol, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; 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 Total Cholesterol (mmol/L) from Baseline to Week 26', 'unitOfMeasure': 'mmol/L', '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 Cholesterol (HDL) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.377', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.02', 'pValueComment': 'No adjustments for multiplicity were performed', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02', 'groupDescription': 'MMRM ANCOVA with change in HDL as the dependent variable; treatment, baseline HDL, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; 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 (mmol/L) from Baseline to Week 26', 'unitOfMeasure': 'mmol/L', '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 at Week 26 to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.15', 'pValueComment': 'No adjustments for multiplicity were performed', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'groupDescription': 'Triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed by MMRM ANCOVA with change in triglycerides as the dependent variable; treatment, baseline triglycerides, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; 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 Triglycerides (measured in mmol/L) at 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': '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': '233', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-3.03', 'spread': '16.57', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '14.88', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '10.08', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '8.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) 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.'}, {'type': 'SECONDARY', 'title': 'Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Once Weekly With SU', 'description': 'Patients assigned to the Exenatide Once Weekly With SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met+SU.'}, {'id': 'OG001', 'title': 'Insulin Glargine With SU', 'description': 'Patients assigned to the Insulin Glargine with SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met+SU.'}, {'id': 'OG002', 'title': 'Exenatide Once Weekly No SU', 'description': 'Patients assigned to the Exenatide Once Weekly No SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met only.'}, {'id': 'OG003', 'title': 'Insulin Glargine No SU', 'description': 'Patients assigned to the Insulin Glargine No SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met only.'}], 'classes': [{'title': 'Major Hypoglycemia', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.030', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Minor Hypoglycemia', 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.184', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.284', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.037', 'groupId': 'OG002'}, {'value': '0.63', 'spread': '0.091', '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 time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level \\<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.', 'unitOfMeasure': 'rate per subject-year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'FG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'Intent to Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '209'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide Once Weekly', 'description': 'Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.'}, {'id': 'BG001', 'title': 'Insulin Glargine', 'description': 'Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.'}, {'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': '184', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '9.72', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '9.08', 'groupId': 'BG001'}, {'value': '57.9', 'spread': '9.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.32', 'spread': '1.094', 'groupId': 'BG000'}, {'value': '8.29', 'spread': '1.020', 'groupId': 'BG001'}, {'value': '8.31', 'spread': '1.057', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '91.22', 'spread': '18.582', 'groupId': 'BG000'}, {'value': '90.56', 'spread': '16.348', 'groupId': 'BG001'}, {'value': '90.90', 'spread': '17.509', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Background Oral Antidiabetic Agent (OAD)', 'classes': [{'title': 'Metformin (Met)', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}]}, {'title': 'Met+Sulfonylurea (SU)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', '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': 467}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2010-08-13', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2008-03-17', 'dispFirstSubmitQcDate': '2010-08-13', 'resultsFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2008-03-20', 'dispFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-31', 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', '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 <=7.0% at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Percentage of patients achieving HbA1c \\<=7.0% at Week 26 (for patients with HbA1c \\>7% at baseline)'}, {'measure': 'Percentage of Patients Achieving HbA1c <=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 (mmol/L) from Baseline to Week 26'}, {'measure': 'Change in Body Weight (BW) From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in BW (kg) from Baseline to Week 26'}, {'measure': 'Change in Total Cholesterol From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Total Cholesterol (mmol/L) from Baseline to Week 26'}, {'measure': 'Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HDL (mmol/L) from Baseline to Week 26'}, {'measure': 'Ratio of Triglycerides at Week 26 to Baseline', 'timeFrame': 'Baseline, Week 26', 'description': 'Ratio of Triglycerides (measured in mmol/L) at 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 Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26'}, {'measure': 'Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes', '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 time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level \\<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'exenatide', 'exenatide once weekly', 'metformin', 'sulfonylurea', 'insulin glargine', 'Amylin', 'Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22357185', 'type': 'RESULT', 'citation': 'Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012 Apr;35(4):683-9. doi: 10.2337/dc11-1233. Epub 2012 Feb 22.'}, {'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': '24731672', 'type': 'DERIVED', 'citation': 'Diamant M, Van Gaal L, Guerci B, Stranks S, Han J, Malloy J, Boardman MK, Trautmann ME. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014 Jun;2(6):464-73. doi: 10.1016/S2213-8587(14)70029-4. Epub 2014 Apr 4.'}, {'pmid': '23748506', 'type': 'DERIVED', 'citation': 'Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.'}, {'pmid': '23522121', 'type': 'DERIVED', 'citation': 'Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.'}, {'pmid': '22236356', 'type': 'DERIVED', 'citation': 'Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.'}, {'pmid': '20609969', 'type': 'DERIVED', 'citation': 'Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has type 2 diabetes and at least 18 years of age at screening.\n* Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.\n* Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.\n* Have a history of stable body weight (not varying by \\>5% for at least 3 months prior to screening).\n* Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR\n* Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.\n\nExclusion Criteria:\n\n* Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.\n* Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.\n* Have a history of renal transplantation or are currently receiving renal dialysis.\n* Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.\n* Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.\n* Have any contraindication for the oral antidiabetic agent which they use.\n* Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.\n* Are known to have active proliferative retinopathy.\n* Have been treated with drugs that promote weight loss (e.g., Xenical® \\[orlistat\\], Meridia® \\[sibutramine\\], Acomplia® \\[rimonabant\\], Acutrim® \\[phenylpropanolamine\\], or similar over-the-counter medications) within 3 months of screening.\n* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:\n\n * Insulin\n * Thiazolidinediones (e.g., Actos® \\[pioglitazone\\] or Avandia® \\[rosiglitazone\\])\n * Alpha-glucosidase inhibitors (e.g., Glyset® \\[miglitol\\] or Precose® \\[acarbose\\])\n * Meglitinides (e.g., Prandin® \\[repaglinide\\] or Starlix® \\[nateglinide\\]).\n * Byetta® (exenatide BID formulation)\n * Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ \\[sitagliptin\\], Galvus® \\[vildagliptin\\])\n * Symlin® (pramlintide acetate).\n* Have had an organ transplant.\n* Have donated blood within 30 days of screening.\n* Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.\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': 'NCT00641056', 'briefTitle': 'Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated 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