Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:50 PM
Study NCT ID:
NCT00870194
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2009-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
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'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], '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'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, '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 + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.', 'otherNumAtRisk': 127, 'otherNumAffected': 36, 'seriousNumAtRisk': 127, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.', 'otherNumAtRisk': 128, 'otherNumAffected': 28, 'seriousNumAtRisk': 128, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lumbar hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c (Percent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.012', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-Inferiority Margin of 0.4%'}, {'pValue': '.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'Standard Error of the Least Square Mean', 'groupDescription': 'Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin of 0.4%'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values \\[X% - Y%\\]', 'unitOfMeasure': 'Percent HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c <=7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.038', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Percentage of patients whose baseline HbA1c was \\> 7.0% achieving HbA1c \\<=7.0% at endpoint (Week 20)', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Per Protocol Set whose baseline HbA1c was \\> 7.0%; Last Observation Carried Forward.Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c <7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.027', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Percentage of patients whose baseline HbA1c was \\>=7.0% achieving HbA1c \\<7.0% at endpoint (Week 20)', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Per Protocol Set whose baseline HbA1c was \\>= 7.0%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c <=6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}, {'value': '20.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.480', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Percentage of patients whose baseline HbA1c was \\> 6.5% achieving HbA1c \\<=6.5% at endpoint (Week 20)', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Per Protocol Set whose baseline HbA1c was \\> 6.5%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Change in FSG (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.038', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.58', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-2.20', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.266', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in body weight from baseline to endpoint (Week 20)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference (cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.25', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.095', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in waist circumference from baseline to endpoint (Week 20)', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Waist-to-Hip Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.567', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in waist-to-hip ratio from baseline to endpoint (Week20)', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'SMBG (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.57', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '8.16', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.207', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': '7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.055', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in triglycerides from baseline to endpoint (Week 20)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Change in HDL (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.269', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Change in LDL (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.622', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.888', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in total cholesterol from baseline to endpoint (Week 20)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycemia (Overall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.287', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Incidence of hypoglycemic episodes experienced overall during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; not confirmed with blood glucose values.'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe Hypoglycemia(Overall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.498', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Incidence of severe hypoglycemia experienced overall during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated Patients; Severe hypo:symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose;or documented hypoglycemia (BG\\< 3.0 mmol/L \\[54/mg/dL\\]) requiring the assistance of another person because of severe impairment in consciousness or behavior'}, {'type': 'SECONDARY', 'title': 'Incidence of Nocturnal Hypoglycemia (Overall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.247', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Incidence of nocturnal hypoglycemia experienced overall during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated Patients'}, {'type': 'SECONDARY', 'title': 'Incidence of Confirmed Hypoglycemia(Overall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'OG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Incidence of confirmed hypoglycemia experienced overall during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; has a concurrent fingerstick blood glucose \\<3.0 mmol/L (54 mg/dL).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'FG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'Per Protocol Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide + Placebo', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.'}, {'id': 'BG001', 'title': 'Exenatide + Sitagliptin', 'description': 'Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '10.97', 'groupId': 'BG000'}, {'value': '54.6', 'spread': '9.66', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '10.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2009-03-25', 'resultsFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-19', 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (Percent)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values \\[X% - Y%\\]'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Achieving HbA1c <=7.0%', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Percentage of patients whose baseline HbA1c was \\> 7.0% achieving HbA1c \\<=7.0% at endpoint (Week 20)'}, {'measure': 'Percentage of Patients Achieving HbA1c <7.0%', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Percentage of patients whose baseline HbA1c was \\>=7.0% achieving HbA1c \\<7.0% at endpoint (Week 20)'}, {'measure': 'Percentage of Patients Achieving HbA1c <=6.5%', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Percentage of patients whose baseline HbA1c was \\> 6.5% achieving HbA1c \\<=6.5% at endpoint (Week 20)'}, {'measure': 'Change in FSG (mmol/L)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)'}, {'measure': 'Change in Body Weight (kg)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in body weight from baseline to endpoint (Week 20)'}, {'measure': 'Change in Waist Circumference (cm)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in waist circumference from baseline to endpoint (Week 20)'}, {'measure': 'Waist-to-Hip Ratio', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in waist-to-hip ratio from baseline to endpoint (Week20)'}, {'measure': 'SMBG (mmol/L)', 'timeFrame': 'Baseline to 20 Weeks', 'description': '7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)'}, {'measure': 'Change in Triglycerides (mmol/L)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in triglycerides from baseline to endpoint (Week 20)'}, {'measure': 'Change in HDL (mmol/L)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)'}, {'measure': 'Change in LDL (mmol/L)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)'}, {'measure': 'Change in Total Cholesterol (mmol/L)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Change in total cholesterol from baseline to endpoint (Week 20)'}, {'measure': 'Incidence of Hypoglycemia (Overall)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Incidence of hypoglycemic episodes experienced overall during the study'}, {'measure': 'Incidence of Severe Hypoglycemia(Overall)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Incidence of severe hypoglycemia experienced overall during the study'}, {'measure': 'Incidence of Nocturnal Hypoglycemia (Overall)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Incidence of nocturnal hypoglycemia experienced overall during the study'}, {'measure': 'Incidence of Confirmed Hypoglycemia(Overall)', 'timeFrame': 'Baseline to 20 Weeks', 'description': 'Incidence of confirmed hypoglycemia experienced overall during the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'exenatide', 'Byetta', 'sitagliptin', 'Januvia', 'Amylin', 'Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22375612', 'type': 'DERIVED', 'citation': 'Violante R, Oliveira JH, Yoon KH, Reed VA, Yu MB, Bachmann OP, Ludemann J, Chan JY. A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitagliptin. Diabet Med. 2012 Nov;29(11):e417-24. doi: 10.1111/j.1464-5491.2012.03624.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Present with type 2 diabetes\n* Patients have been treated with a stable dose of the following for at least 3 months prior to screening:\n\n * 100 mg/day sitagliptin and\n * ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).\n* Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.\n* Have a body mass index (BMI) ≥20 kg/m2 and \\<45 kg/m2\n\nExclusion Criteria:\n\n* Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Have previously completed or withdrawn from this study or any other study investigating exenatide.\n* Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.\n* Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.\n* Are currently treated with any of the following excluded medications:\n\n * Thiazolidinediones (TZD) within 3 months of screening.\n * Sulfonylurea (SU) within 3 months of screening.\n * Dipeptidyl peptidase-4 \\[DPP-4\\] inhibitors, with the exception of sitagliptin, within 3 months of screening.\n * Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.\n * Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.\n * Exogenous insulin within the 3 months prior to screening.\n * Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.\n * Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.\n * Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT00870194', 'briefTitle': 'A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin', 'orgStudyIdInfo': {'id': 'H8O-CR-GWDK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: exenatide and sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: exenatide and placebo']}], 'interventions': [{'name': 'exenatide and sitagliptin', 'type': 'DRUG', 'otherNames': ['exenatide-Byetta; sitagliptin-Januvia'], 'description': 'exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day', 'armGroupLabels': ['1']}, {'name': 'exenatide and placebo', 'type': 'DRUG', 'otherNames': ['exenatide-Byetta'], 'description': 'exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Morón', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.65118, 'lon': -58.62205}}, {'city': 'Adelaide', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Geelong', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'city': 'Aßlar', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.59163, 'lon': 8.46273}}, {'city': 'Beckum-Neubeckum', 'country': 'Germany', 'facility': 'Research Site'}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bosenheim', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.84472, 'lon': 7.91382}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Falkensee', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.56014, 'lon': 13.0927}}, {'city': 'Furth im Wald', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.30955, 'lon': 12.84156}}, {'city': 'Grevenbroich', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.09102, 'lon': 6.5827}}, {'city': 'Hohenmölsen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.15769, 'lon': 12.1}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Neuwied', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.4336, 'lon': 7.47057}}, {'city': 'Othmarschen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55173, 'lon': 9.88632}}, {'city': 'Pohlheim', 'country': 'Germany', 'facility': 'Research Site'}, {'city': 'Speyer', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.32083, 'lon': 8.43111}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Ahmedabad', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Coimbatore', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'city': 'Indore', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'city': 'Jaipur', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Coatzacoalcos', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 18.14905, 'lon': -94.4447}}, {'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Mérida', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Tampico', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 22.28519, 'lon': -97.87777}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Chief Medical Officer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}