{ "FullStudy":{ "Rank":218091, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512849", "OrgStudyIdInfo":{ "OrgStudyId":"TA-7284-07" }, "Organization":{ "OrgFullName":"Mitsubishi Tanabe Pharma Corporation", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment", "OfficialTitle":"An Open-Label, Randomized, 2 Way Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment" }, "StatusModule":{ "StatusVerifiedDate":"May 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 15, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 25, 2014", "ResultsFirstSubmitQCDate":"May 13, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 11, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 13, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 11, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Mitsubishi Tanabe Pharma Corporation", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.", "DetailedDescription":"This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type 2 Diabetes Mellitus" ] }, "KeywordList":{ "Keyword":[ "TA-7284", "JNJ-28431754", "Canagliflozin", "Renal Impairment", "Sodium Glucose Co-transporter2 (SGLT2) inhibitor" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"24", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"TA-7284 Low", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: TA-7284 Low" ] } },{ "ArmGroupLabel":"TA-7284 High", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: TA-7284 High" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"TA-7284 Low", "InterventionDescription":"Low", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "TA-7284 Low" ] } },{ "InterventionType":"Drug", "InterventionName":"TA-7284 High", "InterventionDescription":"High", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "TA-7284 High" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Effect of Renal Function on Maximum Plasma Concentration of TA-7284", "PrimaryOutcomeTimeFrame":"For 72 hours after each administration" },{ "PrimaryOutcomeMeasure":"Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284", "PrimaryOutcomeTimeFrame":"For 72 hours after each administration" },{ "PrimaryOutcomeMeasure":"Effect of Renal Function on Urinary Glucose Excretion of TA-7284", "PrimaryOutcomeTimeFrame":"For 24 hours after each administration" },{ "PrimaryOutcomeMeasure":"Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284", "PrimaryOutcomeDescription":"The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.", "PrimaryOutcomeTimeFrame":"For 24 hours after each administration" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Adverse Events", "SecondaryOutcomeDescription":"Incidence and severity of AEs", "SecondaryOutcomeTimeFrame":"Upto approximately 14 days after last administration" },{ "SecondaryOutcomeMeasure":"12-lead Electrocardiogram (ECG)", "SecondaryOutcomeDescription":"Change from baseline in ECG parameters", "SecondaryOutcomeTimeFrame":"For 72 hours after each administration" },{ "SecondaryOutcomeMeasure":"Vital Signs", "SecondaryOutcomeDescription":"Change from baseline in Vital signs (BP, PR and BT)", "SecondaryOutcomeTimeFrame":"For 72 hours after each administration" },{ "SecondaryOutcomeMeasure":"Clinical Laboratory Tests", "SecondaryOutcomeDescription":"Change from baseline in Clinical laboratory tests", "SecondaryOutcomeTimeFrame":"For 72 hours after each administration" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment\nBody mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening\nHbA1c of ≥6.5% and ≤10.5% at screening\n\nExclusion Criteria:\n\nType 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus\nPast or current history of severe diabetic complications\nPatients requiring insulin therapy\nHistory of hereditary glucose-galactose malabsorption or primary renal glucosuria", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"40 Years", "MaximumAge":"79 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Nobuya Inagaki, MD", "OverallOfficialAffiliation":"Kyoto University, Graduate School of Medicine", "OverallOfficialRole":"Study Director" },{ "OverallOfficialName":"Kazuoki Kondo, MD", "OverallOfficialAffiliation":"Mitsubishi Tanabe Pharma Corporation", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Reserch site", "LocationCity":"Kanto", "LocationCountry":"Japan" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Moderate Renal Impairment Low Dose First", "FlowGroupDescription":"TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Moderate Renal Impairment High Dose First", "FlowGroupDescription":"TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Normal Renal Function Low Dose First", "FlowGroupDescription":"TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2" },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Normal Renal Function High Dose First", "FlowGroupDescription":"TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Crossover Period 1", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Crossover Period 2", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Entire Population for Moderate Renal Impairment" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Entire Population for Normal Renal Function" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"12" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"12" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"24" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"63.7", "BaselineMeasurementSpread":"10.2", "BaselineMeasurementLowerLimit":"40", "BaselineMeasurementUpperLimit":"78" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"57.8", "BaselineMeasurementSpread":"9.7", "BaselineMeasurementLowerLimit":"48", "BaselineMeasurementUpperLimit":"76" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"60.8", "BaselineMeasurementLowerLimit":"40", "BaselineMeasurementUpperLimit":"78" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"24" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Effect of Renal Function on Maximum Plasma Concentration of TA-7284", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng / mL", "OutcomeMeasureTimeFrame":"For 72 hours after each administration", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Moderate Renal Impairment Low", "OutcomeGroupDescription":"TA-7284-Low was administered in a single dose." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Moderate Renal Impairment High", "OutcomeGroupDescription":"TA-7284-High was administered in a single dose." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Normal Renal Function Low", "OutcomeGroupDescription":"TA-7284-Low was administered in a single dose." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Normal Renal Function High", "OutcomeGroupDescription":"TA-7284-High was administered in a single dose." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1197.1264", "OutcomeMeasurementSpread":"310.5625" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2333.3617", "OutcomeMeasurementSpread":"414.8957" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1213.6571", "OutcomeMeasurementSpread":"337.8705" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2415.6109", "OutcomeMeasurementSpread":"739.8783" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Adverse Events", "OutcomeMeasureDescription":"Incidence and severity of AEs", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"Upto approximately 14 days after last administration" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"12-lead Electrocardiogram (ECG)", "OutcomeMeasureDescription":"Change from baseline in ECG parameters", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"For 72 hours after each administration" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Vital Signs", "OutcomeMeasureDescription":"Change from baseline in Vital signs (BP, PR and BT)", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"For 72 hours after each administration" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Clinical Laboratory Tests", "OutcomeMeasureDescription":"Change from baseline in Clinical laboratory tests", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"For 72 hours after each administration" },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng･h/mL", "OutcomeMeasureTimeFrame":"For 72 hours after each administration", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Moderate Renal Impairment Low", "OutcomeGroupDescription":"TA-7284-Low was administered in a single dose." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Moderate Renal Impairment High", "OutcomeGroupDescription":"TA-7284-High was administered in a single dose." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Normal Renal Function Low", "OutcomeGroupDescription":"TA-7284-Low was administered in a single dose." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Normal Renal Function High", "OutcomeGroupDescription":"TA-7284-High was administered in a single dose." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8766", "OutcomeMeasurementSpread":"2551" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"17835", "OutcomeMeasurementSpread":"4434" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6929", "OutcomeMeasurementSpread":"1734" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14815", "OutcomeMeasurementSpread":"4162" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Effect of Renal Function on Urinary Glucose Excretion of TA-7284", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"g", "OutcomeMeasureTimeFrame":"For 24 hours after each administration", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Moderate Renal Impairment Low", "OutcomeGroupDescription":"TA-7284-Low was administered in a single dose." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Moderate Renal Impairment High", "OutcomeGroupDescription":"TA-7284-High was administered in a single dose." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Normal Renal Function Low", "OutcomeGroupDescription":"TA-7284-Low was administered in a single dose." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Normal Renal Function High", "OutcomeGroupDescription":"TA-7284-High was administered in a single dose." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"61.017", "OutcomeMeasurementLowerLimit":"49.362", "OutcomeMeasurementUpperLimit":"72.671" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"70.904", "OutcomeMeasurementLowerLimit":"59.184", "OutcomeMeasurementUpperLimit":"82.624" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"86.592", "OutcomeMeasurementLowerLimit":"75.612", "OutcomeMeasurementUpperLimit":"97.572" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"103.052", "OutcomeMeasurementLowerLimit":"88.952", "OutcomeMeasurementUpperLimit":"117.152" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284", "OutcomeMeasureDescription":"The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percent of RGR at baseline", "OutcomeMeasureTimeFrame":"For 24 hours after each administration", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Moderate Renal Impairment Low", "OutcomeGroupDescription":"TA-7284-Low was administered in a single dose." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Moderate Renal Impairment High", "OutcomeGroupDescription":"TA-7284-High was administered in a single dose." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Normal Renal Function Low", "OutcomeGroupDescription":"TA-7284-Low was administered in a single dose." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Normal Renal Function High", "OutcomeGroupDescription":"TA-7284-High was administered in a single dose." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60.8", "OutcomeMeasurementLowerLimit":"52.4", "OutcomeMeasurementUpperLimit":"69.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"66.5", "OutcomeMeasurementLowerLimit":"59.5", "OutcomeMeasurementUpperLimit":"73.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"47.8", "OutcomeMeasurementLowerLimit":"42.2", "OutcomeMeasurementUpperLimit":"53.4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"52.7", "OutcomeMeasurementLowerLimit":"45.4", "OutcomeMeasurementUpperLimit":"60.0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Up to approximately 14 days after last administration", "EventsDescription":"Serious adverse events and the other adverse events were summarized in terms of renal function and dose.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Moderate Renal Impairment Low", "EventGroupDescription":"TA-7284-Low was administered in a single dose.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"12", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"12" },{ "EventGroupId":"EG001", "EventGroupTitle":"Moderate Renal Impairment High", "EventGroupDescription":"TA-7284-High was administered in a single dose.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"12", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"12" },{ "EventGroupId":"EG002", "EventGroupTitle":"Normal Renal Function Low", "EventGroupDescription":"TA-7284-Low was administered in a single dose.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"12", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"12" },{ "EventGroupId":"EG003", "EventGroupTitle":"Normal Renal Function High", "EventGroupDescription":"TA-7284-High was administered in a single dose.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"12", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"12" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 15", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 15", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Nasopharyngitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 15", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Blood creatin phosphokinase increased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 15", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Blood creatinine increased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 15", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Blood glucose increased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 15", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Protein urine present", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 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