Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-01 @ 12:27 PM
Study NCT ID:
NCT01581658
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2012-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Renal Impairment Study of Empagliflozin (BI10773) in Japanese 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': '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}}, 'adverseEventsModule': {'timeFrame': 'From trial drug intake until the end-of-study examination visit, up to 12 days', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Renal Function', 'description': '25 mg empagliflozin taken as a single dose for patients with normal renal function', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mild Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with mild renal impairment', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Moderate Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with moderate renal impairment', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Severe Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with severe renal impairment', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Urinary Glucose Excretion (UGE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': '25 mg empagliflozin taken as a single dose for patients with normal renal function'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with mild renal impairment'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with moderate renal impairment'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with severe renal impairment'}], 'classes': [{'categories': [{'measurements': [{'value': '74969.3', 'spread': '4840.68', 'groupId': 'OG000', 'lowerLimit': '64978.6', 'upperLimit': '84960.0'}, {'value': '62577.4', 'spread': '5751.25', 'groupId': 'OG001', 'lowerLimit': '50707.5', 'upperLimit': '74447.4'}, {'value': '57889.0', 'spread': '4861.26', 'groupId': 'OG002', 'lowerLimit': '47855.9', 'upperLimit': '67922.2'}, {'value': '23725.1', 'spread': '5235.06', 'groupId': 'OG003', 'lowerLimit': '12920.5', 'upperLimit': '34529.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 24 hours', 'description': 'change from baseline in total urinary glucose excretion (UGE) to 24 hours', 'unitOfMeasure': 'mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who had complete urine sample (baseline and 24 hours) for analyses.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration Time Curve of the Analyte in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': '25 mg empagliflozin taken as a single dose for patients with normal renal function'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with mild renal impairment'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with moderate renal impairment'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with severe renal impairment'}], 'classes': [{'categories': [{'measurements': [{'value': '7480', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '9630', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '10800', 'spread': '9.55', 'groupId': 'OG002'}, {'value': '11400', 'spread': '40.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '128.82', 'ciLowerLimit': '105.962', 'ciUpperLimit': '156.604', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes fixed effect for the renal function group'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '143.82', 'ciLowerLimit': '118.306', 'ciUpperLimit': '174.848', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes fixed effect for the renal function group'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '152.31', 'ciLowerLimit': '125.287', 'ciUpperLimit': '185.166', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes fixed effect for the renal function group'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration', 'description': 'Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients'}, {'type': 'PRIMARY', 'title': 'Maximum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Renal Function', 'description': '25 mg empagliflozin taken as a single dose for patients with normal renal function'}, {'id': 'OG001', 'title': 'Mild Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with mild renal impairment'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with moderate renal impairment'}, {'id': 'OG003', 'title': 'Severe Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with severe renal impairment'}], 'classes': [{'categories': [{'measurements': [{'value': '1050', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '984', 'spread': '30.8', 'groupId': 'OG001'}, {'value': '971', 'spread': '26.2', 'groupId': 'OG002'}, {'value': '990', 'spread': '43.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.50', 'ciLowerLimit': '72.236', 'ciUpperLimit': '121.015', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes fixed effect for the renal function group'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.18', 'ciLowerLimit': '71.216', 'ciUpperLimit': '119.305', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes fixed effect for the renal function group'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.01', 'ciLowerLimit': '72.630', 'ciUpperLimit': '121.674', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes fixed effect for the renal function group'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration', 'description': 'Maximum concentration of the analyte in plasma', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Renal Function', 'description': '25 mg empagliflozin taken as a single dose for patients with normal renal function'}, {'id': 'FG001', 'title': 'Mild Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with mild renal impairment'}, {'id': 'FG002', 'title': 'Moderate Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with moderate renal impairment'}, {'id': 'FG003', 'title': 'Severe Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with severe renal impairment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Renal Function', 'description': '25 mg empagliflozin taken as a single dose for patients with normal renal function'}, {'id': 'BG001', 'title': 'Mild Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with mild renal impairment'}, {'id': 'BG002', 'title': 'Moderate Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with moderate renal impairment'}, {'id': 'BG003', 'title': 'Severe Renal Impairment', 'description': '25 mg empagliflozin taken as a single dose for patients with severe renal impairment'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '67.5', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '5.5', 'groupId': 'BG002'}, {'value': '62.0', 'spread': '7.9', 'groupId': 'BG003'}, {'value': '65.5', 'spread': '5.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-04', 'studyFirstSubmitDate': '2012-04-17', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Urinary Glucose Excretion (UGE)', 'timeFrame': 'baseline and 24 hours', 'description': 'change from baseline in total urinary glucose excretion (UGE) to 24 hours'}, {'measure': 'Area Under the Concentration Time Curve of the Analyte in Plasma', 'timeFrame': 'Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration', 'description': 'Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity'}, {'measure': 'Maximum Concentration', 'timeFrame': 'Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration', 'description': 'Maximum concentration of the analyte in plasma'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '25199997', 'type': 'DERIVED', 'citation': 'Sarashina A, Ueki K, Sasaki T, Tanaka Y, Koiwai K, Sakamoto W, Woerle HJ, Salsali A, Broedl UC, Macha S. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus. Clin Ther. 2014 Nov 1;36(11):1606-15. doi: 10.1016/j.clinthera.2014.08.001. Epub 2014 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Type 2 diabetes patients\n* Glycosylated haemoglobin\\>= 6.1% (Japan Diabetes Society)\n* Estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of \\>= 15 mL/min/1.73m2\n\nExclusion criteria:\n\n* Any evidence of significant disease (other than renal impairment)\n* Moderate and severe concurrent liver function impairment\n* Gastrointestinal tract surgery, that might affect absorption and elimination of drugs\n* Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders\n* Chronic or relevant acute infections\n* Participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial'}, 'identificationModule': {'nctId': 'NCT01581658', 'briefTitle': 'Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase I, Open-label, Parallel-group Study to Investigate Pharmacokinetics, Pharmacodynamics and Safety of a Single 25 mg Dose of Empagliflozin in Japanese Type 2 Diabetes Patients With Different Degrees of Renal Impairment in Comparison to Type 2 Diabetes Patients With Normal Renal Function', 'orgStudyIdInfo': {'id': '1245.53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI10773 medium dose group 1', 'description': 'BI10773 medium dose tablet single dose group 1', 'interventionNames': ['Drug: BI10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI10773 medium dose group 2', 'description': 'BI10773 medium dose tablet single dose group 2', 'interventionNames': ['Drug: BI10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI10773 Medium dose group 3', 'description': 'BI10773 medium dose tablet single dose group 3', 'interventionNames': ['Drug: BI10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI10773 Medium dose group 4', 'description': 'BI10773 medium dose tablet single dose group 4', 'interventionNames': ['Drug: BI10773']}], 'interventions': [{'name': 'BI10773', 'type': 'DRUG', 'description': 'BI10773 medium dose tablet single dose', 'armGroupLabels': ['BI10773 medium dose group 2']}, {'name': 'BI10773', 'type': 'DRUG', 'description': 'BI10773 medium dose tablet single dose', 'armGroupLabels': ['BI10773 Medium dose group 4']}, {'name': 'BI10773', 'type': 'DRUG', 'description': 'BI10773 medium dose tablet single dose', 'armGroupLabels': ['BI10773 medium dose group 1']}, {'name': 'BI10773', 'type': 'DRUG', 'description': 'BI10773 medium dose tablet single dose', 'armGroupLabels': ['BI10773 Medium dose group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kurume, Fukuoka', 'country': 'Japan', 'facility': '1245.53.001 Boehringer Ingelheim Investigational Site'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}