Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT00885118
Status:
COMPLETED
Last Update Posted:
2014-11-25
First Post:
2009-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)
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': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".'}}, 'adverseEventsModule': {'timeFrame': 'Between the first drug administration and the end of the trial after the last drug administration, up to 28 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Treatment with placebo once daily', 'otherNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Empa 1 mg', 'description': 'Treatment with Empa 1 mg once daily', 'otherNumAtRisk': 19, 'otherNumAffected': 6, 'seriousNumAtRisk': 19, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Empa 5 mg', 'description': 'Treatment with Empa 5 mg once daily', 'otherNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Empa 10 mg', 'description': 'Treatment with Empa 10 mg once daily', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, 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'MEDDRA 12.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.1'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 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'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value was included as a continuous covariate', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.487', 'ciLowerLimit': '-33.308', 'ciUpperLimit': '-11.665', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.445', 'groupDescription': 'Difference calculated as empa 5mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value was included as a continuous covariate', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.265', 'ciLowerLimit': '-37.762', 'ciUpperLimit': '-14.768', 'dispersionType': 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'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data'}, {'type': 'SECONDARY', 'title': 'RA,AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empa 1 mg', 'description': 'Treatment with Empa 1 mg once daily'}, {'id': 'OG001', 'title': 'Empa 5 mg', 'description': 'Treatment with Empa 5 mg once daily'}, {'id': 'OG002', 'title': 'Empa 10 mg', 'description': 'Treatment with Empa 10 mg once daily'}, {'id': 'OG003', 'title': 'Empa 25 mg', 'description': 'Treatment with Empa 25 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '42.5', 'groupId': 'OG001'}, {'value': '1.32', 'spread': '13.1', 'groupId': 'OG002'}, {'value': '1.23', 'spread': '12.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration', 'description': 'accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data'}, {'type': 'SECONDARY', 'title': 'Ae0-24,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 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'nmol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data'}, {'type': 'SECONDARY', 'title': 'fe0-24,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empa 1 mg', 'description': 'Treatment with Empa 1 mg once daily'}, {'id': 'OG001', 'title': 'Empa 5 mg', 'description': 'Treatment with Empa 5 mg once daily'}, {'id': 'OG002', 'title': 'Empa 10 mg', 'description': 'Treatment with Empa 10 mg once daily'}, {'id': 'OG003', 'title': 'Empa 25 mg', 'description': 'Treatment with Empa 25 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '44.5', 'groupId': 'OG001'}, {'value': '21.6', 'spread': '18.6', 'groupId': 'OG002'}, {'value': '20.8', 'spread': '24.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-5, 5-12, 12-24 hour after last drug administration', 'description': 'fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24', 'unitOfMeasure': 'percentage of Ae0-24 (to dosage)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data'}, {'type': 'SECONDARY', 'title': 'CLR,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empa 1 mg', 'description': 'Treatment with Empa 1 mg once 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'populationDescription': 'Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Treatment with placebo once daily'}, {'id': 'FG001', 'title': 'Empa 1 mg', 'description': 'Treatment with Empa 1 mg once daily'}, {'id': 'FG002', 'title': 'Empa 5 mg', 'description': 'Treatment with Empa 5 mg once daily'}, {'id': 'FG003', 'title': 'Empa 10 mg', 'description': 'Treatment with Empa 10 mg once daily'}, {'id': 'FG004', 'title': 'Empa 25 mg', 'description': 'Treatment with Empa 25 mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Treatment with placebo once daily'}, {'id': 'BG001', 'title': 'Empa 1 mg', 'description': 'Treatment with Empa 1 mg once daily'}, {'id': 'BG002', 'title': 'Empa 5 mg', 'description': 'Treatment with Empa 5 mg once daily'}, {'id': 'BG003', 'title': 'Empa 10 mg', 'description': 'Treatment with Empa 10 mg once daily'}, {'id': 'BG004', 'title': 'Empa 25 mg', 'description': 'Treatment with Empa 25 mg once daily'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '53.9', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '55.8', 'spread': '8.0', 'groupId': 'BG003'}, {'value': '60.8', 'spread': '8.7', 'groupId': 'BG004'}, {'value': '57.2', 'spread': '9.2', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '84', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2009-04-20', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2009-04-20', 'lastUpdatePostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2009-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Urine Glucose Excretion', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in Urine glucose excretion to 28 days'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in Fasting plasma glucose to 28 days'}, {'measure': 'Change From Baseline in 8-point Glucose', 'timeFrame': 'baseline and 27 days', 'description': 'Change from baseline in 8-point glucose to 27 days'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in HbA1c to 28 days'}, {'measure': 'Change From Baseline in Fructosamine', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in Fructosamine to 28 days'}, {'measure': 'Change From Baseline in 1,5-anhydroglucitol', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in 1,5-anhydroglucitol to 28 days'}, {'measure': 'Change From Baseline in Fasting Insulin', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in Fasting insulin to 28 days'}, {'measure': 'Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days'}, {'measure': 'Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days'}, {'measure': 'Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)', 'timeFrame': 'baseline and 28 days', 'description': 'Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days'}, {'measure': 'AUCτ,1', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ'}, {'measure': 'AUC0-tz', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration', 'description': 'area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration'}, {'measure': 'AUC0-∞', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration', 'description': 'area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity'}, {'measure': 'Cmax', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration', 'description': 'maximum measured concentration of the analyte in plasma'}, {'measure': 't1/2', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration', 'description': 'terminal half-life of the analyte in plasma'}, {'measure': 'CL/F', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration', 'description': 'apparent clearance of the analyte in plasma after extravascular administration'}, {'measure': 'Vz/F', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration', 'description': 'apparent volume of distribution during the terminal phase λz following an extravascular dose'}, {'measure': 'Ae0-24', 'timeFrame': '0-5, 5-12, 12-24 hour after first drug administration', 'description': 'amount of the analyte that is eliminated in urine over the time interval 0 to 24'}, {'measure': 'fe0-24', 'timeFrame': '0-5, 5-12, 12-24 hour after first drug administration', 'description': 'fraction of the analyte excreted unchanged in urine from time interval 0 to 24'}, {'measure': 'CLR,0-24', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration', 'description': 'renal clearance of the analyte in plasma after extravascular administration - based on 0-24 hours data'}, {'measure': 'AUCτ,ss', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration', 'description': 'area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state'}, {'measure': 'Cmax,ss', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration', 'description': 'maximum measured concentration of the analyte in plasma at steady state'}, {'measure': 't1/2,ss', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration', 'description': 'terminal half-life of the analyte in plasma at steady state'}, {'measure': 'CL/F,ss', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration', 'description': 'apparent clearance of the analyte in plasma after extravascular administration at steady state'}, {'measure': 'Vz/F,ss', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration', 'description': 'apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state'}, {'measure': 'RA,Cmax', 'timeFrame': 'Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration', 'description': 'accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax'}, {'measure': 'RA,AUC', 'timeFrame': 'Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration', 'description': 'accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ'}, {'measure': 'Ae0-24,ss', 'timeFrame': '0-5, 5-12, 12-24 hour after last drug administration', 'description': 'amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24'}, {'measure': 'fe0-24,ss', 'timeFrame': '0-5, 5-12, 12-24 hour after last drug administration', 'description': 'fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24'}, {'measure': 'CLR,ss', 'timeFrame': 'Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration', 'description': 'renal clearance of the analyte at steady state determined over the dosing interval τ'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '35472672', 'type': 'DERIVED', 'citation': 'Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.'}, {'pmid': '29488164', 'type': 'DERIVED', 'citation': 'Yasui A, Lee G, Hirase T, Kaneko T, Kaspers S, von Eynatten M, Okamura T. Empagliflozin Induces Transient Diuresis Without Changing Long-Term Overall Fluid Balance in Japanese Patients With Type 2 Diabetes. Diabetes Ther. 2018 Apr;9(2):863-871. doi: 10.1007/s13300-018-0385-5. Epub 2018 Feb 27.'}, {'pmid': '24843716', 'type': 'DERIVED', 'citation': "Kanada S, Koiwai K, Taniguchi A, Sarashina A, Seman L, Woerle HJ. Pharmacokinetics, pharmacodynamics, safety and tolerability of 4 weeks' treatment with empagliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Nov 27;4(6):613-7. doi: 10.1111/jdi.12110. Epub 2013 Jun 25."}, {'pmid': '23940010', 'type': 'DERIVED', 'citation': 'Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.\n2. Hemoglobin A1c (HbA1c) at screening (Visit 1)\n\n * For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and 9.0%.\n * For patients not treated with any antidiabetic drug: HbA1c between 7.0% and 10.0%.\n3. Age between 20 and 70 years\n4. Body mass index (BMI) between18.0 and 40.0 kg/m2\n5. Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.\n\nExclusion criteria:\n\n1. Antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent\n2. Fasted blood glucose of \\>240 mg/dL (\\>13.3 mmol/L) or a randomly determined blood glucose level of \\>400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out period.\n3. Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.\n4. Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as\n\n * Renal insufficiency (calculated estimated glomerular filtration rate \\<60)\n * Cardiac insufficiency of New York Heart Association (NYHA) II-IV or other known cardiovascular diseases including hypertension of \\>160/95 mmHg,\n * Neurological disorders (such as epilepsy) or psychiatric disorders\n * Acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)\n * Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder\n5. Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:\n\n * Statins.\n * Antihypertensives (diuretics not allowed)\n * alpha-Blockers for benign prostate hypertrophy\n * Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol\n6. Additional inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT00885118', 'briefTitle': '4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1245.15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 10773 low dose quaque die (QD)', 'description': 'patient to receive a BI 10773 low dose tablet and a placebo tablet once daily', 'interventionNames': ['Drug: BI 10773', 'Drug: Placebo (low dose)']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 mid-low dose QD', 'description': 'patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily', 'interventionNames': ['Drug: Placebo (middle dose)', 'Drug: BI 10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 mid-high dose QD', 'description': 'patient to receive two tablets of BI 10773 middle dose once daily', 'interventionNames': ['Drug: BI 10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 high dose QD', 'description': 'patient to receive a BI 10773 high dose tablet and a placebo tablet once daily', 'interventionNames': ['Drug: BI 10773', 'Drug: Placebo (high dose)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patient to receive two tablets of placebo once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo (middle dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 mid-low dose QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['Placebo']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'BI 10773 middle dose tablets once a day', 'armGroupLabels': ['BI 10773 mid-high dose QD']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'BI 10773 high dose tablets once a day', 'armGroupLabels': ['BI 10773 high dose QD']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'BI 10773 middle dose tablets once a day', 'armGroupLabels': ['BI 10773 mid-low dose QD']}, {'name': 'Placebo (high dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 high dose QD']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'BI 10773 low dose tablets once a day', 'armGroupLabels': ['BI 10773 low dose quaque die (QD)']}, {'name': 'Placebo (low dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 low dose quaque die (QD)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hachioji, Tokyo', 'country': 'Japan', 'facility': '1245.15.003 Boehringer Ingelheim Investigational Site'}, {'city': 'Koganei, Tokyo', 'country': 'Japan', 'facility': '1245.15.002 Boehringer Ingelheim Investigational Site'}, {'city': 'Nakano-ku, Tokyo', 'country': 'Japan', 'facility': '1245.15.001 Boehringer Ingelheim Investigational Site'}, {'city': 'Suita, Osaka', 'country': 'Japan', 'facility': '1245.15.005 Boehringer Ingelheim Investigational Site'}, {'city': 'Yokohama, Kanagawa', 'country': 'Japan', 'facility': '1245.15.004 Boehringer Ingelheim Investigational Site'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}