{ "FullStudy":{ "Rank":217941, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514838", "OrgStudyIdInfo":{ "OrgStudyId":"1941-CL-2003" }, "Organization":{ "OrgFullName":"Astellas Pharma Inc", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus", "OfficialTitle":"A Phase III, Double-Blind, Randomized, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus" }, "StatusModule":{ "StatusVerifiedDate":"December 2018", "OverallStatus":"Terminated", "WhyStopped":"Discontinued due to company's strategic reason", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 23, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 19, 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 19, 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 13, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 17, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Astellas Pharma Inc", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.", "DetailedDescription":"This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be provided." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type II Diabetes Mellitus" ] }, "KeywordList":{ "Keyword":[ "urine glucose", "ipragliflozin", "plasma glucose", "ASP1941" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"46", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"1941 group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Once daily over a 24-week treatment period", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: ASP1941", "Drug: Placebo" ] } },{ "ArmGroupLabel":"acarbose group", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Once daily over a 24-week treatment period", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: acarbose", "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"ASP1941", "InterventionDescription":"oral", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "1941 group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "ipragliflozin" ] } },{ "InterventionType":"Drug", "InterventionName":"acarbose", "InterventionDescription":"oral", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "acarbose group" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"oral, used only during placebo run-in period", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "1941 group", "acarbose group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in HbA1c from baseline to end of treatment", "PrimaryOutcomeTimeFrame":"Baseline and up to 24 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in fasting plasma glucose level", "SecondaryOutcomeTimeFrame":"Baseline and up to 24 weeks" },{ "SecondaryOutcomeMeasure":"Change in fasting serum insulin level", "SecondaryOutcomeTimeFrame":"Baseline and up to 24 weeks" },{ "SecondaryOutcomeMeasure":"Change in body weight", "SecondaryOutcomeTimeFrame":"Baseline and up to 24 weeks" },{ "SecondaryOutcomeMeasure":"Change in body waist circumference", "SecondaryOutcomeTimeFrame":"Baseline and up to 24 weeks" },{ "SecondaryOutcomeMeasure":"Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG", "SecondaryOutcomeTimeFrame":"For 24 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\ndiagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study\nstable diet and exercise program for at least 6 weeks before the study\nfor the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy\nBMI of 20.0 to 45.0 kg/m2\nfor the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period\nfor the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period\n\nExclusion Criteria:\n\ntype 1 diabetes mellitus\nproliferative diabetic retinopathy\nreceiving insulin within 12 weeks prior to the study\nhistory of clinically significant renal disease(s)\nsignificant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.\nurinary tract infection or genital infection\ncontinuous use of systemic corticosteroids, immunosuppressants, or loop diuretics\nhistory of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study\nsevere infection, serious trauma, or perioperative subject\nknown or suspected hypersensitivity to ASP1941, acarbose or other alpha-GI\nhistory of treatment with ASP1941\nparticipated in another clinical study, postmarketing study or medical device study within 12 weeks before the study\nserum creatinine value exceeding the upper limit of normal range\nurinary microalbumin/urinary creatinine ratio >300 mg/g", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Use Central Contact", "OverallOfficialAffiliation":"Astellas Pharma Inc", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Busan", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Daegu", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Daejeon", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Gwangju", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Incheon", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seongnam", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seoul", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Wonju", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Changha", "LocationCountry":"Taiwan" },{ "LocationCity":"Chiayi", "LocationCountry":"Taiwan" },{ "LocationCity":"Kaohsiung", "LocationCountry":"Taiwan" },{ "LocationCity":"Taichung", "LocationCountry":"Taiwan" },{ "LocationCity":"Tainan", "LocationCountry":"Taiwan" },{ "LocationCity":"Taipei", "LocationCountry":"Taiwan" },{ "LocationCity":"Taoyuan", "LocationCountry":"Taiwan" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Link to results on Astellas Clinical Study Results website", "SeeAlsoLinkURL":"https://astellasclinicalstudyresults.com/study.aspx?ID=108" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No", "IPDSharingDescription":"Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under \"Sponsor Specific Details for Astellas.\"" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000020909", "InterventionMeshTerm":"Acarbose" },{ "InterventionMeshId":"C000572941", "InterventionMeshTerm":"Ipragliflozin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000065089", "InterventionAncestorTerm":"Glycoside Hydrolase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000007004", "InterventionAncestorTerm":"Hypoglycemic Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000077203", "InterventionAncestorTerm":"Sodium-Glucose Transporter 2 Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M21228", "InterventionBrowseLeafName":"Acarbose", "InterventionBrowseLeafAsFound":"Acarbose", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M262724", "InterventionBrowseLeafName":"Ipragliflozin", "InterventionBrowseLeafAsFound":"Ipragliflozin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M4139", "InterventionBrowseLeafName":"Cardiac Glycosides", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29034", "InterventionBrowseLeafName":"Glycoside Hydrolase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8637", "InterventionBrowseLeafName":"Hypoglycemic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1691", "InterventionBrowseLeafName":"Sodium-Glucose Transporter 2 Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AnArAg", "InterventionBrowseBranchName":"Anti-Arrhythmia Agents" },{ "InterventionBrowseBranchAbbrev":"CaAg", "InterventionBrowseBranchName":"Cardiotonic Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" },{ "ConditionMeshId":"D000003924", "ConditionMeshTerm":"Diabetes Mellitus, Type 2" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5702", "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2", "ConditionBrowseLeafAsFound":"Type II Diabetes Mellitus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }