阿格列汀临床资料.docx
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阿格列汀临床资料.docx
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阿格列汀临床资料
ClinicalTrialDetails
TrialTitle:
EfficacyandSafetyofAlogliptinUsedinCombinationWithSulfonylureainParticipantswithType2DiabetesinJapan
OfficialTitle:
APhaseII/III,Double-Blind,Randomized,Placebo-Controlled,Parallel-Group,MulticenterStudytoDeterminetheEfficacyandSafetyofSYR-322WhenUsedinCombinationwithSulfonylureainSubjectswithTypeIIDiabetesinJapan
StudyType:
Interventional
Biomarker:
(GlycatedOrGlycosylatedHaemoglobin(HbA1c))
ActualStartDate:
01Aug2008
ExpectedCompletionDate:
01Apr2009
Duration:
8Months
StudyDesign(s):
AllocationRandomized
ControlTypePlacebo-controlled
EndpointClassificationEfficacy;Safety
InterventionalModelParallelAssignment
MaskingDoubleBlind
PrimaryPurposeTreatment
TrialcharacteristicsMulti-centered
Purpose:
Thepurposeofthisstudywastoevaluatetheefficacyandsafetyofalogliptin,oncedaily(QD)combinedwithansulfonylureatakenQDortwicedaily(BID)intype2diabeticsubjectswithuncontrolledbloodglucose.
StudyHypothesis:
herewasnopostulatedhypothesis.However,GlobalDataassumedthatalogliptinandglimepiridemaybesafeandeffectivethanglimepiridealoneintype2diabeticsubjectswithuncontrolledbloodglucose.
PrimaryOutcomeMeasure(s)/Objective(s):
ChangefromBaselineinGlycosylatedHemoglobin(Week12)
Thechangeinthevalueofglycosylatedhemoglobin(theconcentrationofglucoseboundtohemoglobinasapercentoftheabsolutemaximumthatcanbebound)collectedatweek12orfinalvisitandglycosylatedhemoglobincollectedatbaseline
SecondaryOutcomeMeasure(s)/Objective(s):
∙ChangefromBaselineinGlycosylatedHemoglobin(Week2)
∙Thechangeinthevalueofglycosylatedhemoglobin(theconcentrationofglucoseboundtohemoglobinasapercentoftheabsolutemaximumthatcanbebound)collectedatweek2andglycosylatedhemoglobincollectedatbaseline
oChangefromBaselineinGlycosylatedHemoglobin(Week4)
∙Thechangeinthevalueofglycosylatedhemoglobin(theconcentrationofglucoseboundtohemoglobinasapercentoftheabsolutemaximumthatcanbebound)collectedatweek4andglycosylatedhemoglobincollectedatbaseline
oChangefromBaselineinGlycosylatedHemoglobin(Week8)
∙Thechangeinthevalueofglycosylatedhemoglobin(theconcentrationofglucoseboundtohemoglobinasapercentoftheabsolutemaximumthatcanbebound)collectedatweek8andglycosylatedhemoglobincollectedatbaseline
oChangefromBaselineinFastingPlasmaGlucose(Week2)
∙Thechangebetweenthevalueoffastingplasmaglucosecollectedatweek2andbaseline
oChangefromBaselineinFastingPlasmaGlucose(Week4)
∙Thechangebetweenthevalueoffastingplasmaglucosecollectedatweek4andbaseline
oChangefromBaselineinFastingPlasmaGlucose(Week8)
∙Thechangebetweenthevalueoffastingplasmaglucosecollectedatweek8andbaseline
oChangefromBaselineinFastingPlasmaGlucose(Week12)
∙Thechangebetweenthevalueoffastingplasmaglucosecollectedatweek12orfinalvisitandbaseline
oChangefromBaselineinBloodGlucosemeasuredbythemealtolerancetest(Week2)
∙Thechangebetweenthevalueofbloodglucosemeasuredbythemealtolerancetestcollectedatweek2andbloodglucosemeasuredbythemealtolerancetestcollectedatbaseline
oChangefromBaselineinBloodGlucosemeasuredbythemealtolerancetest(Week4)
∙Thechangebetweenthevalueofbloodglucosemeasuredbythemealtolerancetestcollectedatweek4andbloodglucosemeasuredbythemealtolerancetestcollectedatbaseline
oChangefromBaselineinBloodGlucosemeasuredbythemealtolerancetest(Week8)
∙Thechangebetweenthevalueofbloodglucosemeasuredbythemealtolerancetestcollectedatweek8andbloodglucosemeasuredbythemealtolerancetestcollectedatbaseline
oChangefromBaselineinBloodGlucosemeasuredbythemealtolerancetest(Week12)
∙Thechangebetweenthevalueofbloodglucosemeasuredbythemealtolerancetestcollectedatweek12orfinalvisitandbloodglucosemeasuredbythemealtolerancetestcollectedatbaseline
TrialDescription:
Thiswasan interventional, phaseII/III,randomized,placebocontrolled,multicentered,dosecomparision,parallelassignment,doubleblindand treatmentstudyto evaluatetheefficacyandsafetyofalogliptin,oncedaily(QD)combinedwithanSulfonylureatakenQDortwicedaily(BID)intype2diabetic subjectswithuncontrolledbloodglucose.
Subjectswererandomizedintotwoarms.
Arms
ArmType
AssignedInterventions
Description
ArmI
Experimental
Alogliptin+Glimepiride
Subjectsreceived12.5mgofalogliptinfour timesdailyand glimepiridefour timesdailyortwicedaily(BID)orallyoronceortwicedailyfortheperiodof upto12weeks.
ArmII
Experimental
Alogliptin +Glimepiride
Subjectsreceived25mgofalogliptinfour timesdailyand glimepiridefour timesdailyortwicedaily(BID)orallyoronceortwicedailyfortheperiodof upto12weeks.
ArmIII
Activecomparator
Glimepiride+Placebo
Subjectsreceived1,2,3or4mgofglimepiridetwiceorfourtimesdailyandalogliptinplacebo-matchingtablets,orallyor oncedailyfortheperiodof upto12weeks.
Atotalof312subjectswereplannedto beenrolledinthisstudy.
DrugDetails
ActualNumberofDrug(s):
1
ProductName:
alogliptinbenzoate(PipelineProduct)
ProductDescription:
Nesina(agoliptin,SYR-322)isunderdevelopmentforthetreatmentfortype2diabetesmellitus.Thedrugcandidateisadministeredorally.AlogliptinisadipeptidylpeptidaseIV(DPP-4)inhibitor.DipeptidylpeptidaseIV(DPP-4)inhibitorarecompoundsthatsuppressthedegradationofincretinsbyblockingtheactionofdipeptidyl-peptidaseIV.Thishelpstocorrectthedefectiveinsulinandglucagonsecretioncharacteristicoftype2diabetesmellitusbystimulatinginsulinsecretionandsuppressingglucagonrelease.DPP-4istheprimaryenzymeinvolvedinthedegradationofglucagon-likepeptide-1(GLP-1)andglucose-dependentinsulinotropicpeptide.GLP-1hasthepotentialtoimprovebetacellfunction.
MechanismofAction:
Nesina(alogliptin)isadipeptidylpeptidaseIV(DPP-4)inhibitor.DPP-4inhibitorsblockstheenzymedipeptidylpeptidase-4(DPP-4),whichselectivelymetabolizestheinsulin-increasinghormonesglucagon-likepeptide1(GLP-1)andglucose-dependentinsulinotropicpeptide(GIP).GLP-1andGIPareexcretedinthedigestivetractfollowingfoodintake,andstimulatethebeta-cellsinthepancreastherebystimulatingincreasedinsulinsecretionandtheyimprovethefunctioningofthebetacellsthemselves.GLP-1suppressesglucagonsecretionfromthepancreas,theproductionofsugarinlivercellsisalsosuppressedandappetiteissuppressedaswell.DPP-4inhibitorslowstheinactivationofincretinhormonesGLP-1(glucagon-likepeptide-1)andGIP(glucose-dependentinsulinotropicpeptide),whichplayamajorroleinregulatingbloodglucoselevelsandhavethepotentialtoimprovepancreaticbeta-cellfunction.
ATCClassification:
A10BHDipeptidylpeptidase4(DPP-4)inhibitors
Target:
DipeptidylPeptidaseIV(DPP-IVorCD26)
R&DProgress:
ResearchandDevelopmentBrief:
TakedaPharmaceuticalCompanyLimitedisengagedinthedevelopmentofNesina(agoliptinbenzoate,SYR-322)forthetreatmentoftype2diabetesmellitus.Nesina(agoliptin,SYR-322).SYR-322isfiledforNewDrugApplication(NDA)inChina,Europe,Indonesia,Brazil,SouthKorea,Switzerland,AustraliaandTaiwan.NesinahasbeenapprovedinJapansinceJune2010andthetherapyiscurrentlyavailableunderthebrandnameNesinainthismarket.NesinaisalsoapprovedinU.S.forthetreatmentoftype2diabetes.ThecompanyisexpectingtoreceiveapprovalforthedrugcandidateapprovalinEuropeinthefinancialyear2013.Alsoalogliptinbenzoateincombinationwithroflumilastisunderdevelopmentforthetreatmentoftype2diabetes.
06/15/2010:
TakedaPharmaceuticalCompanyLimitedlaunchedNESINAfortreatmentoftype2diabetesinJapan.
LicensingandCollaboration:
In2003,PPDenteredintoacollaborationagreementtodevelopSyrrx’sorallyactiveDPP4inhibitorstotreattype2diabetesandothermajorhumandiseases.InMarch2005,TakedaacquiredSyrrx.InJuly2005,TakedaacquireddevelopmentandcommercializationrightstotheseDPP4inhibitorsfromPPDforanupfrontpayment,potentialmilestonepaymentsandroyaltiesassociatedwiththefuturedevelopmentandcommercializationofspecifiedDPP4inhibitorsandtherighttoserveasthesoleproviderofclinicalandbioanalyticalservicestoTakedaforPhaseIIandPhaseIIItrialsofDPP4inhibitorsconductedintheUnitedStatesandEurope.
PhaseI-TrialDetails:
InJuly2012,TakedaGlobalResearchandDevelopmentCenter,IncinitiatedPhaseIstudyofroflumilastplusalogliptinonpostprandialactiveGLP-1leveland24-hourglucoselevelinsubjectswithtype2diabeteswhoareinadequatelycontrolledonastabledoseofmetformin.Thepurposeofstudyistoassesstheeffectofroflumilastplusalogliptinonglucagon-likepeptide-1(GLP-1)andglucoselevelsinpatientswithtype2diabetes.Theprimaryoutcomemeasuresischangefrombaselineinpostprandialareaunderthecurvefromtime0to8hours(auc[0-8])foractiveglucagon-likepeptide-1atday11.Thesecondaryoutcomemeasuresarechangesfrombaselineinauc(0-8)ofpostprandialglucoseatday11,changefrombaselineinauc(0-8)ofc-peptideatday11,changefrombaselineinauc(0-8)ofinsulinatday11,changefrombaselineinauc(0-8)ofappetitesensationasmeasuredbyvisualanalogscale(vas)atday11andchangefrombaselinein24-hourplasmaglucoseassessedbycontinuousglucosemonitoringsystem.InNovember2009,Ta
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