Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT02715258
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2016-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes
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': 'C000705992', 'term': 'bexagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acollinson@theracos.com', 'phone': '(508) 630-2129', 'title': 'Albert Collinson', 'organization': 'Theracos Sub, LLC'}, 'certainAgreement': {'otherDetails': 'The Investigator does not have the right to publish the results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject was to take bexagliflozin tablets, 20 mg once daily for 24 weeks.', 'otherNumAtRisk': 138, 'deathsNumAtRisk': 138, 'otherNumAffected': 41, 'seriousNumAtRisk': 138, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Tablets', 'description': 'Each subject was to take placebo (inactive tablet) once daily for 24 weeks.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 25, 'seriousNumAtRisk': 69, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo Tablets', 'description': 'Each subject will receive placebo (inactive tablet) once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '-0.16', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Analysis of change from baseline in HbA1c (%) at Week 24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.15', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Sensitivity Analysis 1: Multiple imputation for change from baseline in HbA1c (%) including observations obtained after rescue medication', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.30', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Sensitivity Analysis 2: Multiple imputation for change from baseline in HbA1c (%) excluding observations obtained after rescue medication', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '-0.17', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Sensitivity Analysis 3: LOCF for change from baseline in HbA1c (%) including observations obtained after rescue medication', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.', 'unitOfMeasure': '% of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure (SBP) From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo Tablets', 'description': 'Each subject will receive placebo (inactive tablet) once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'spread': '1.145', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '1.524', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.14', 'ciLowerLimit': '-5.66', 'ciUpperLimit': '1.39', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Analysis of change from baseline in SBP (mm Hg) at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2937', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.91', 'ciLowerLimit': '-5.48', 'ciUpperLimit': '1.66', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Sensitivity Analysis 1: Multiple imputation for change from baseline in SBP (mm Hg) including observations obtained after rescue medication', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.72', 'ciLowerLimit': '-5.75', 'ciUpperLimit': '2.32', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Sensitivity Analysis 2: Multiple imputation for change from baseline in SBP (mm Hg) excluding observations obtained after rescue medication', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2160', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.09', 'ciLowerLimit': '-5.41', 'ciUpperLimit': '1.23', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Blood pressure (BP) measurements are obtained using a calibrated sphygmomanometer in sitting, supine and standing positions. The left arm and same cuff sizes should be used for each measurement at all visits. If the left arm cannot be used at the screening visit or during the study for BP measurements, the reason should be documented and the right arm should be used for BP measurements for all subsequent visits.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo Tablets', 'description': 'Each subject will receive placebo (inactive tablet) once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.85', 'spread': '0.394', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '0.485', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '0.21', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Analysis of change from baseline in body weight (kg) at Week 24 for subjects with BMI greater than or equal to 25 kg/m2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '0.35', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Sensitivity Analysis 1: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0638', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.88', 'ciUpperLimit': '0.05', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Sensitivity Analysis 2: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 excluding observations obtained after rescue medication', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1456', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '0.24', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Sensitivity Analysis 3: LOCF for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'The body weight was obtained using a calibrated scale as part of complete physical examination or abbreviated physical examination.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with BMI \\>= 25 kg/m2 in the ITT analysis set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo Tablets', 'description': 'Each subject will receive placebo (inactive tablet) once daily for 24 weeks.'}], 'classes': [{'title': 'Change from baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '2.116', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '2.655', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.41', 'spread': '1.904', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '2.103', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'spread': '2.058', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '2.337', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'spread': '2.013', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '2.480', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.50', 'ciLowerLimit': '-1.92', 'ciUpperLimit': '-1.09', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Analysis of change from baseline in FPG (mmol/L) over time across 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The fasting plasma glucose (FPG) is measured at each study visit. The subject must have fasted for approximately 10 hours prior to the blood draw to ensure that the FPG value is truly a fasting sample.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with a value at baseline and Week 6, 12, 18 and 24'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline of HbA1c From Baseline Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo Tablets', 'description': 'Each subject will receive placebo (inactive tablet) once daily for 24 weeks.'}], 'classes': [{'title': 'Change from baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.082', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.095', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.093', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '-0.43', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Change from baseline in HbA1c (%) at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.50', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Change from baseline in HbA1c (%) at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '-0.36', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Change from baseline in HbA1c (%) at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '-0.16', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Change from baseline in HbA1c (%) at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mixed-effects repeated measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.39', 'pValueComment': 'The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Change from baseline in HbA1c (%) across 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.', 'unitOfMeasure': '% of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with a value at baseline and at Week 6, 12, 18 and 24'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Subjects Who Achieve an HbA1c < 7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo Tablets', 'description': 'Each subject will receive placebo (inactive tablet) once daily for 24 weeks.'}], 'classes': [{'title': 'Proportion of subjects with HbA1c < 7% at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Proportion of subjects with HbA1c < 7% at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Proportion of subjects with HbA1c < 7% at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Proportion of subjects with HbA1c < 7% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.39', 'ciLowerLimit': '1.69', 'ciUpperLimit': '6.80', 'pValueComment': 'The logistic regression includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.', 'groupDescription': 'Model-Adjusted proportion of subjects with HbA1c \\<7% across 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with a value at baseline and at Week 6, 12, 18 and 24'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.'}, {'id': 'FG001', 'title': 'Placebo Tablets', 'description': 'Each subject will receive placebo (inactive tablet) once daily for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Intent to Treat/Safety Analysis', 'comment': 'Three randomized subject numbers were excluded in the ITT and the safety populations due to GCP violation.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'GCP violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 210 subjects were randomized to be in the bexagliflozin arm or in the placebo arm in a ratio of 2:1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bexagliflozin Tablets, 20 mg', 'description': 'Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.'}, {'id': 'BG001', 'title': 'Placebo Tablets', 'description': 'Each subject will receive placebo (inactive tablet) once daily for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'spread': '10.21', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '11.02', 'groupId': 'BG001'}, {'value': '55.4', 'spread': '10.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '100', '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': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '154', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'spread': '20.48', 'groupId': 'BG000'}, {'value': '84.6', 'spread': '19.75', 'groupId': 'BG001'}, {'value': '88.6', 'spread': '20.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '32.79', 'spread': '5.653', 'groupId': 'BG000'}, {'value': '30.48', 'spread': '4.650', 'groupId': 'BG001'}, {'value': '32.01', 'spread': '5.437', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '131.0', 'spread': '14.35', 'groupId': 'BG000'}, {'value': '125.6', 'spread': '13.84', 'groupId': 'BG001'}, {'value': '129.2', 'spread': '14.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.05', 'spread': '0.824', 'groupId': 'BG000'}, {'value': '7.97', 'spread': '0.757', 'groupId': 'BG001'}, {'value': '8.02', 'spread': '0.801', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '9.39', 'spread': '1.957', 'groupId': 'BG000'}, {'value': '9.45', 'spread': '2.079', 'groupId': 'BG001'}, {'value': '9.41', 'spread': '1.994', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes from Diagnosis to Screening', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '5.82', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '5.21', 'groupId': 'BG001'}, {'value': '6.1', 'spread': '5.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-04', 'size': 583194, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-30T16:09', 'hasProtocol': True}, {'date': '2017-04-14', 'size': 592850, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-30T16:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2017-06-13', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2016-03-11', 'dispFirstSubmitQcDate': '2017-06-26', 'resultsFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2016-03-16', 'dispFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-01', 'studyFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) Over Time', 'timeFrame': '24 weeks', 'description': 'The fasting plasma glucose (FPG) is measured at each study visit. The subject must have fasted for approximately 10 hours prior to the blood draw to ensure that the FPG value is truly a fasting sample.'}, {'measure': 'Change From Baseline of HbA1c From Baseline Over Time', 'timeFrame': '24 weeks', 'description': 'Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.'}, {'measure': 'Proportion of Subjects Who Achieve an HbA1c < 7%', 'timeFrame': 'Up to 24 weeks', 'description': 'Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.'}], 'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline at Week 24', 'timeFrame': '24 weeks', 'description': 'Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.'}], 'secondaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure (SBP) From Baseline at Week 24', 'timeFrame': '24 weeks', 'description': 'Blood pressure (BP) measurements are obtained using a calibrated sphygmomanometer in sitting, supine and standing positions. The left arm and same cuff sizes should be used for each measurement at all visits. If the left arm cannot be used at the screening visit or during the study for BP measurements, the reason should be documented and the right arm should be used for BP measurements for all subsequent visits.'}, {'measure': 'Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2', 'timeFrame': '24 weeks', 'description': 'The body weight was obtained using a calibrated scale as part of complete physical examination or abbreviated physical examination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).', 'detailedDescription': 'This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of once daily oral administration of bexagliflozin tablets, 20 mg or placebo tablets, in male and female subjects with T2DM who were treatment-naïve or previously treated with 1 oral hypoglycemic agent (OHA).\n\nProspective subjects being treated with one OHA were eligible if they had an HbA1c between 6.5% and 10.0% and were willing to complete a 6-week washout. Individuals taking thiazolidinediones were not eligible for the study. All eligible subjects were to start a 2-week placebo run-in period. Subjects who missed no more than 1 dose of the run-in medication, had fasting blood glucose values ≥ 250 mg/dL on no more than two consecutive days, and had an HbA1c level between 7.0% and 10.5% and a fasting glucose level \\< 250 mg/dL after the run-in period were eligible for randomization.\n\nTwo hundred and ten (210) subjects were planned to be randomly assigned to receive oral bexagliflozin tablets, 20 mg or placebo, in a 2:1 ratio once daily for 24 weeks. Subjects with uncontrolled hyperglycemia based on blood glucose levels could receive additional approved anti-diabetic medications. Treatment group assignment at the start of the treatment period was stratified by baseline HbA1c level and background anti-diabetes treatment status (treatment naïve or not).\n\nEach subject was contacted by telephone at week 2 and was instructed to return to the clinic at weeks 6, 12, 18, and 24 for efficacy assessment and safety monitoring. Subjects returned to the clinic for a follow-up visit at week 26 or 2 weeks after the last dose of investigational product if the subject terminated prior to week 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "The study population included:\n\n1. Male or female adult subjects ≥ 18 years of age at screening\n2. Subjects who were treatment naïve or receiving 1 OHA in combination with diet and exercise\n3. Subjects with a diagnosis of T2DM\n4. Subjects with HbA1c levels at screening between 7.0% and 10.5% (inclusive) if treatment-naïve or with HbA1c levels between 6.5 and 10.0% (inclusive) if on 1 oral anti diabetic agent\n5. Subjects with a BMI ≤ 45 kg/m2\n6. Subjects whose doses of medications for hypertension or hyperlipidemia (if applicable) had not changed for at least 30 days prior to screening\n7. Subjects who were willing and able to return for all clinic visits and to complete all study required procedures\n8. Female subjects of childbearing potential who were willing to use an adequate method of contraception and not become pregnant for the duration of the study.\n9. Subjects who maintained glycemic control throughout washout, if applicable.\n10. Subjects who had HbA1c levels between 7.0 and 10.5% prior to randomization\n11. Subjects who had been compliant in investigational product administration by missing no more than 1 dose of run-in medication\n\nSubjects who met any of the following criteria were excluded from the study:\n\n1. A diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young\n2. Use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs at the time of screening\n3. Female subjects who were pregnant or breastfeeding\n4. Hemoglobinopathy or carrier status for hemoglobin alleles that affected HbA1c measurement\n5. Genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis) within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within 6 months from screening\n6. Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), \\< 60 mL/min/1.73 m2 at screening\n7. Uncontrolled hypertension defined as a sitting systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\> 95 mm Hg at screening\n8. A positive result for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV)\n9. History of alcohol or illicit drug abuse in the past 2 years\n10. Known human immunodeficiency virus (HIV) positive based on medical history\n11. Life expectancy \\< 2 years\n12. New York Heart Association (NYHA) Class IV heart failure within 3 months of screening\n13. MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening\n14. Treatment with an investigational drug within 30 days or within 7 half-lives of the investigational drug, whichever was longer\n15. Previous treatment with bexagliflozin or EGT0001474\n16. Use of any SGLT2 inhibitors, either at the time of screening or in the prior 3 months\n17. Currently participating in another interventional trial\n18. Not able to comply with the study scheduled visits\n19. Any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the primary investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment\n20. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x ULN or total bilirubin ≥ 1.5 x upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome at screening\n21. Two or more consecutive FPG measures ≥ 250 mg/dL (13.9 mmol/L) prior to randomization or severe clinical signs or symptoms of hyperglycemia during the washout or run-in periods, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue\n22. At last visit prior to randomization, FPG level ≥ 250 mg/dL\n23. Prior renal transplantation or evidence of nephrotic syndrome (defined as a urine albumin-to-creatinine ratio (UACR) \\> 2000 mg/g at screening)."}, 'identificationModule': {'nctId': 'NCT02715258', 'briefTitle': 'Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theracos'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Compare the Efficacy and Safety of Bexagliflozin to Placebo in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control', 'orgStudyIdInfo': {'id': 'THR-1442-C-450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bexagliflozin tablets, 20 mg', 'description': 'Each subject will self-administer bexagliflozin tablets once daily for 24 weeks.', 'interventionNames': ['Drug: Bexagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tablets', 'description': 'Each subject will self-administer placebo (inactive tablet) once daily for 24 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bexagliflozin', 'type': 'DRUG', 'otherNames': ['EGT0001442'], 'description': 'tablets containing 20 mg bexagliflozin', 'armGroupLabels': ['Bexagliflozin tablets, 20 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'tablets matching the appearance of bexagliflozin tablets', 'armGroupLabels': ['Placebo tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '08611', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '28467', 'city': 'Calabash', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.89073, 'lon': -78.56834}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '44262', 'city': 'Munroe Falls', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.1445, 'lon': -81.43983}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29582', 'city': 'North Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.81601, 'lon': -78.68002}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '76164', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': 'V6J 1S3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site 2', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9W 4L6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site 1', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H9R 4S3', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}], 'overallOfficials': [{'name': 'J. Paul Lock, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theracos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theracos', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}