Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 6:09 PM
Study NCT ID:
NCT01276106
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2011-01-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of AC-201 in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025292', 'term': 'diacerein'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Carl.Brown@twipharma.com', 'phone': '+886-2-26573350', 'title': 'Medical Director', 'phoneExt': '368', 'organization': 'TWi Biotechnology, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'AC-201, 25mg BID', 'description': 'AC-201: Capsule, 25mg BID', 'otherNumAtRisk': 65, 'otherNumAffected': 19, 'seriousNumAtRisk': 65, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'AC-201, 50mg BID', 'description': 'AC-201: Capsule, 50mg BID', 'otherNumAtRisk': 64, 'otherNumAffected': 25, 'seriousNumAtRisk': 64, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'AC-201, 75mg BID', 'description': 'AC-201: Capsule, 75mg BID', 'otherNumAtRisk': 65, 'otherNumAffected': 38, 'seriousNumAtRisk': 65, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo: Capsule, BID', 'otherNumAtRisk': 65, 'otherNumAffected': 15, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chromatouria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Renal Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastric Ulcer Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Stress Urinary Incontenence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-201, 25mg BID', 'description': 'AC-201: Capsule, 25mg BID'}, {'id': 'OG001', 'title': 'AC-201, 50mg BID', 'description': 'AC-201: Capsule, 50mg BID'}, {'id': 'OG002', 'title': 'AC-201, 75mg BID', 'description': 'AC-201: Capsule, 75mg BID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo: Capsule, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.126', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.125', 'groupId': 'OG002'}, {'value': '0.22', 'spread': '0.123', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.01', 'pValueComment': 'No adjustments for multiple comparisons were made and a value of p\\<0.05 was considered statistically significant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.175', 'groupDescription': 'Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0979', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.05', 'pValueComment': 'No adjustments for multiple comparisons were made and a value of p\\<0.05 was considered statistically significant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.176', 'groupDescription': 'Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2643', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.15', 'pValueComment': 'No adjustments for multiple comparisons were made and a value of p\\<0.05 was considered statistically significant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.174', 'groupDescription': 'Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p\\<0.05.', 'unitOfMeasure': 'percentage points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline HbA1c assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AC-201, 25mg BID', 'description': 'AC-201: Capsule, 25mg BID'}, {'id': 'FG001', 'title': 'AC-201, 50mg BID', 'description': 'AC-201: Capsule, 50mg BID'}, {'id': 'FG002', 'title': 'AC-201, 75mg BID', 'description': 'AC-201: Capsule, 75mg BID'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo: Capsule, BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Insufficient therapeutic effects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The participants were recruited in 21 study centers, which were located in 2 countries (USA and Taiwan)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '259', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AC-201, 25mg BID', 'description': 'AC-201: Capsule, 25mg BID'}, {'id': 'BG001', 'title': 'AC-201, 50mg BID', 'description': 'AC-201: Capsule, 50mg BID'}, {'id': 'BG002', 'title': 'AC-201, 75mg BID', 'description': 'AC-201: Capsule, 75mg BID'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo: Capsule, BID'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '9', 'groupId': 'BG000'}, {'value': '55', 'spread': '9', 'groupId': 'BG001'}, {'value': '57', 'spread': '9', 'groupId': 'BG002'}, {'value': '55', 'spread': '8', 'groupId': 'BG003'}, {'value': '56', 'spread': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '150', 'groupId': 'BG004'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '8.4', 'spread': '0.7', 'groupId': 'BG003'}, {'value': '8.4', 'spread': '0.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline was defined as the last measurement obtained on or before the first dose of the study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2011-01-11', 'resultsFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-17', 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline', 'timeFrame': '24 weeks', 'description': 'For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p\\<0.05.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AC-201', 'Interleukin 1 inhibitor'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a 24-week randomized placebo-controlled study to investigate the effect of an oral IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on different background diabetes therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Understanding of the study procedures and agreement to participate in the study by giving written informed consent\n* Males and females age 20 to 75 years, inclusive\n* HbA1c ≥7.5% and ≤10%\n* BMI ≤45 kg/m2\n* FPG ≤270 mg/dL\n* Diagnosis of type 2 diabetes mellitus for ≥6 months\n* On a stable regimen of oral anti-diabetic medications for ≥3 months\n* Willingness to maintain stable diet and exercise throughout the study\n* Willingness to maintain current doses/regimens of vitamins and dietary supplements throughout the study\n* Female patients of childbearing potential and female partners of male patients must be willing to use adequate contraception during the study. All females of childbearing potential must have a negative urine pregnancy test at screening.\n\nExclusion Criteria:\n\n* History of type 1 diabetes and/or history of ketoacidosis\n* History of diabetic neuropathy resulting in significant functional impairment and/or requiring active medical or surgical management, including chronic pain syndromes, gastroparesis, skin ulceration, or amputation\n* History of long-term therapy with insulin (\\>30 days) within 1 year of screening;\n* Pregnancy or lactation\n* Current treatment with any of the following medications within 2 months of screening\n* Anti inflammatory drugs, including chronic daily use of systemic corticosteroids (aspirin ≤325 mg per day is allowed)\n* IL-1 modulators: anakinra and rilonacept\n* Immunosuppressive drugs: TNF inhibitors and IL-6 monoclonal antibody\n* History of severe hypoglycemic episodes within 6 months of screening\n* Hypersensitivity to AC-201 or anthraquinone derivatives\n* Surgery within 30 days prior to screening\n* Serum creatinine \\>1.5 mg/dL for males or \\>1.4 mg/dL for females\n* Presence of cancer or history of cancer within the past 5 years other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix\n* Advanced stage heart failure: New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure\n* History of unstable angina, myocardial infarction, uncontrolled arrhythmias, cerebrovascular accident, transient ischemic attack, or any revascularization, including percutaneous transluminal coronary angioplasty, within 6 months of screening\n* Uncontrolled hypertension (defined as systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg on ≥3 assessments at screening)\n* Known to be infected with human immunodeficiency virus (HIV)\n* History of acquired immune deficiency syndrome\n* History of TB, active TB (pulmonary, extra-pulmonary, or military), or a positive test for TB confirmed by a PA chest x-ray within 6 months prior to screening\n* History of acute infection with Epstein-Barr Virus (EBV), cytomegalovirus (CMV), or hepatitis C virus (HCV) within 4 weeks prior to screening\n* History of chronic active (not latent) hepatitis B virus, HCV, or CMV infection;\n* History of drug or alcohol abuse\n* Aspartate aminotransferase \\>3 × the upper limit of normal (ULN) or alanine aminotransferase \\>3 × ULN at screening\n* Total bilirubin \\>1.5 × ULN at screening\n* Triglycerides \\>500 mg/dL at screening\n* Poor mental function or any other reason to expect patient difficulty in complying with the study requirements\n* Acute infections that may affect blood glucose control within 4 weeks prior to screening\n* Known bilateral renal artery stenosis, patient with a solitary kidney, or a post renal transplant\n* History of autoimmune disease or collagen vascular disease\n* History of hyperthyroidism or hypocorticism\n* Participation in any AC-201 studies within 1 year prior to screening\n* Participation in an investigational drug study within 30 days prior to screening\n* Any other serious diseases which, in the opinion of the investigator, might pose a risk to the patient or make participation not in the patient's best interest."}, 'identificationModule': {'nctId': 'NCT01276106', 'briefTitle': 'Study of AC-201 in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'TWi Biotechnology, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase II Study of AC-201 in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'AC-201-DM-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC-201, 25mg', 'description': '25mg BID for 24 weeks', 'interventionNames': ['Drug: AC-201, 25mg']}, {'type': 'EXPERIMENTAL', 'label': 'AC-201, 50mg', 'description': '50mg BID for 24 weeks', 'interventionNames': ['Drug: AC-201, 50mg']}, {'type': 'EXPERIMENTAL', 'label': 'AC-201, 75mg', 'description': '75mg BID for 24 weeks', 'interventionNames': ['Drug: AC-201, 75mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo BID for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AC-201, 25mg', 'type': 'DRUG', 'description': 'Capsule, 25mg BID', 'armGroupLabels': ['AC-201, 25mg']}, {'name': 'AC-201, 50mg', 'type': 'DRUG', 'description': 'Capsule, 50mg BID', 'armGroupLabels': ['AC-201, 50mg']}, {'name': 'AC-201, 75mg', 'type': 'DRUG', 'description': 'Capsule, 75mg BID', 'armGroupLabels': ['AC-201, 75mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo BID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute, LLC', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of South Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Impotence Treatment Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Clinical Research Institute, Inc.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Investigation Specialists, Inc.', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'L-MARC Research Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'New Orleans Center for Clinical Research', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sterling Research Group, Ltd', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'PriMed Clinical Research', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'National Clinical Research-Richmond, Inc.', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center, Inc.', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Cheng Ching General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Kuang Tien General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Cardinal Tien Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University-Shuang Ho Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TWi Biotechnology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}