Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-01-13 @ 8:59 AM
Study NCT ID:
NCT03052400
Status:
TERMINATED
Last Update Posted:
2023-05-18
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Mifepristone in Males 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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stanleyhsia@cdrewu.edu', 'phone': '323-357-3633', 'title': 'Stanley H. Hsia, MD', 'organization': 'Charles R. Drew University of Medicine and Science'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Administrative barriers and pandemic closures limited enrollment, curtailed several secondary outcome measures, and caused early termination of the study.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'Adverse events not including hypoglycemia', 'eventGroups': [{'id': 'EG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Work-related injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolonged QT Interval', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Worsening of heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Glycemic lowering', 'unitOfMeasure': 'Percentage of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Weight in kg', 'unitOfMeasure': 'kg, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Body mass index in kg/m\\^2', 'unitOfMeasure': 'kg/m^2, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Systolic blood pressure', 'unitOfMeasure': 'mm Hg, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Diastolic blood pressure', 'unitOfMeasure': 'mm Hg, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LDL-cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '19.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Low-density lipoprotein cholesterol', 'unitOfMeasure': 'mg/dL, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cortisol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Serum cortisol level (AM)', 'unitOfMeasure': 'mg/dL, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ACTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'spread': '39.8', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Serum adrenocorticotrophic hormone level (AM)', 'unitOfMeasure': 'pg/mL, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Serum uric acid level', 'unitOfMeasure': 'mg/dL, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Prostate-specific antigen level', 'unitOfMeasure': 'ng/mL, change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 3 months', 'description': 'Symptomatic mild and severe hypoglycemic events', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 3 months', 'description': 'Non-hypoglycemia-related adverse events', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Basal Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '17.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Total daily basal insulin dosage', 'unitOfMeasure': 'Units of insulin per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mifepristone 600 mg Daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks\n\nMifepristone 600 mg daily: Glucocorticoid receptor antagonist'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks\n\nPlacebo: Matching placebo'}, {'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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '9.8', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '9.8', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes duration', 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '14.0', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '12.9', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Basal insulin daily dose', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '19.4', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '39.5', 'groupId': 'BG001'}, {'value': '69.2', 'spread': '28.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Units per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '107.6', 'spread': '46.5', 'groupId': 'BG000'}, {'value': '99.8', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '103.7', 'spread': '29.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '15.0', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '37.8', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-15', 'size': 333634, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-22T21:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'End of Funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2017-02-08', 'resultsFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-22', 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': 'Baseline to 3 months', 'description': 'Glycemic lowering'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline to 3 months', 'description': 'Weight in kg'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline to 3 months', 'description': 'Body mass index in kg/m\\^2'}, {'measure': 'Systolic BP', 'timeFrame': 'Baseline to 3 months', 'description': 'Systolic blood pressure'}, {'measure': 'Diastolic BP', 'timeFrame': 'Baseline to 3 months', 'description': 'Diastolic blood pressure'}, {'measure': 'LDL-cholesterol', 'timeFrame': 'Baseline to 3 months', 'description': 'Low-density lipoprotein cholesterol'}, {'measure': 'Cortisol', 'timeFrame': 'Baseline to 3 months', 'description': 'Serum cortisol level (AM)'}, {'measure': 'ACTH', 'timeFrame': 'Baseline to 3 months', 'description': 'Serum adrenocorticotrophic hormone level (AM)'}, {'measure': 'Uric Acid', 'timeFrame': 'Baseline to 3 months', 'description': 'Serum uric acid level'}, {'measure': 'PSA', 'timeFrame': 'Baseline to 3 months', 'description': 'Prostate-specific antigen level'}, {'measure': 'Hypoglycemic Events', 'timeFrame': 'Baseline to 3 months', 'description': 'Symptomatic mild and severe hypoglycemic events'}, {'measure': 'Adverse Events', 'timeFrame': 'Baseline to 3 months', 'description': 'Non-hypoglycemia-related adverse events'}, {'measure': 'Basal Insulin Dose', 'timeFrame': 'Baseline to 3 months', 'description': 'Total daily basal insulin dosage'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 diabetes mellitus', 'insulin resistance', 'mifepristone', 'glucocorticoids'], 'conditions': ['Type 2 Diabetes Mellitus', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': "Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated with Cushing's syndrome", 'detailedDescription': "Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated with Cushing's syndrome, and sub-optimally controlled on basal insulin, with or without prandial insulin and/or maximally-tolerated doses of metformin."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Males\n* Age 18-65 inclusive\n* Established T2DM for ≥ 1 year\n* Taking stable doses (≤ 20% change in total daily insulin dose within 2 months prior to screening) of basal insulin, with or without prandial insulin (total daily dose must be ≤ 200 units)\n* Baseline hemoglobin A1c (HbA1c) 8.0%-10.5%\n\nExclusion criteria:\n\n* No use of any anti-hyperglycemic agents (oral or injectable) other than metformin or insulin\n* No history or clinical suspicion of type 1 diabetes mellitus\n* No concurrent chronic use of any corticosteroids by any route and for any indication, or concurrent conditions that may require the initiation of glucocorticoids during the study\n* No concurrent lipid-lowering medications whose levels are dependent on CYP3A pathway clearance (e.g., simvastatin, lovastatin, atorvastatin, fluvastatin and rosuvastatin) should either be washed out for at least one month prior to enrollment and/or switched to alternative LDL-cholesterol lowering agents (e.g., pravastatin or ezetimibe) for at least one month.\n* No contraindications or known intolerance to mifepristone\n* No concurrent use of strong CYP3A inhibitors (e.g., cyclosporine, ergotamine, fentanyl, quinidine, sirolimus, tacrolimus, imidazole antifungals, HIV protease inhibitors, certain macrolide antibiotics)\n* No concurrent use of CYP3A inducers (e.g., phenytoin, phenobarbital, carbamazepine, rifampin)\n* No concurrent use of medications that may prolong the QT interval (e.g., selected antipsychotics and antidepressants, quinolone antibiotics)\n* No daily use of warfarin or non-steroidal anti-inflammatory agents\n* Baseline K+ and Mg+2 within the laboratory normal ranges, with or without oral K+ and/or Mg+2 supplementation\n* Fasting plasma glucose (FPG) averaging \\< 280 mg/dL and without polyuria or polydipsia\n* No symptomatic hypoglycemia averaging \\> once per day\n* Able and willing to perform self-monitoring of blood glucose (SMBG)\n* Mean BP \\< 140 mmHg systolic or 90 mm Hg diastolic\n* Baseline LDL-cholesterol \\< 200 mg/dL if on lipid-lowering therapy or \\< 250 mg/dL while not on lipid-lowering therapy\n* Fasting triglycerides ≤ 500 mg/dL if on lipid-lowering therapy\n* HDL-cholesterol ≥ 25 mg/dL\n* No known history of prostate cancer, or elevated level of prostate-specific antigen (PSA) at screening\n* Estimated GFR ≥ 30 mL/min\n* No concurrent endocrinopathies that have not been stabilized with replacement or other definitive therapies (including known adrenal insufficiency regardless of replacement therapy, cortisol \\< 5 μg/dL at screening)\n* No active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c potentially unreliable\n* No other clinically significant hepatic, cardiovascular (including known personal or family history of, or risk factors for long-QT syndrome, QTcF prolongation on ECG \\> 500 ms), infectious (including HIV or any viral hepatitis), inflammatory, neoplastic or other systemic disease that may contraindicate the change of lipid-lowering therapy, renders mifepristone unsafe, or otherwise confounds data interpretation\n* Subjects not likely to start other drugs that may influence the study's outcomes (e.g., weight loss agents)\n* Subjects who are able and willing to comply with all components of the study protocol, attend all scheduled follow-up visits, or who do not present other foreseeable barriers that might make the implementation of the protocol problematic or confound data interpretation"}, 'identificationModule': {'nctId': 'NCT03052400', 'briefTitle': 'Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Charles Drew University of Medicine and Science'}, 'officialTitle': 'Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '16-04-2482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mifepristone 600 mg daily', 'description': 'Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks', 'interventionNames': ['Drug: Mifepristone 600 mg daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mifepristone 600 mg daily', 'type': 'DRUG', 'otherNames': ['Korlym'], 'description': 'Glucocorticoid receptor antagonist', 'armGroupLabels': ['Mifepristone 600 mg daily']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Charles Drew University of Medicine and Science', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Stanley H Hsia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles Drew University of Medicine and Science'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'Data sharing as per NIH funding requirements', 'accessCriteria': 'Contact investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Stanley Hsia', 'investigatorAffiliation': 'Charles Drew University of Medicine and Science'}}}}