Transcription of リベルサス錠 3mg - Pmda
1 Module 1 of 83 3mg 7mg Module 2 of 83 .. 2 .. 5 .. 6 .. !.. "#$%.. '() * +.. ,- ./ , '89: ;<=>.. = NOPQR ,-' YZ[\ .. ]^2_` , ghRijgh ^ z{.. ^ |}9 .. @~ K 2^ ^7 .. ` .. w w 0: .. R ) : C5 DUVWX2 ` 34 Module 3 of u .. @~- a .. K .. # : / UGbX .. #UabX .. UGbX .. D ) C5 DUVWX #$%2R UVWX gh K .. < K |}9 .. < 52gh U . U K |}9.
2 B K .. a .. UabX ]^.. #.. #$% .. b K .. 65 Module 4 of C5 DUVWX #$%2R UVWX gh |([ R UabX .. |([ .. |([ R UabX w LMUVWX ,- bX .. ~../ 01 UVWX ~ ~ .. X ~ ,- ~.. R 2_R .. IJ .UVWX ~.. 77 .. 78 Module 5 of 83 ,-45 c .. 10 13 UVWX,-' YZ[\ ef .. 21 ?@~- a ghRijgh 25 ?@~ 63a745 Rij 63a745 26 ' 3w7 14 mggh AnUVWX2^ |}9 LM 2"#$% 28 423345w422345w422245w423445w428045 29 ?)))]]]
3 @~UGbX ~ IJ2^mn .. 30 ^7 2 ?@~UGbX .. 32 HbA1c ~R ?@~ a .. 35 % ~ estimand 5 41 ~ in-trial 5 42 C5D in-trial 5 43 kg 09: ~ estimand 5 46 H bar plot on-treatment 5 51 u H dot plot on-treatment 5 52 : U IJ ij MACE bX 422145 in-trial .. 59 : U IJ : 9: : : ij U bX in-trial 422145 .. 60 Module 6 of 83 #$%2 5 15 @AB 5 16 EF 5 18 09:=K 5 20 Module 7 of 83 ADAA merican Diabetes Association #$%` ALTalanine aminotransferase 0*: 0: | 0 L ANCOVA analysis of covariance ul u AUCarea under the concentration-time curve j ASTaspartate aminotransferase Z0 : 0.
4 | 0 L BMIbody-mass index ~ (kg) n (m)2 Cavgaverage steady-state concentration in a dosing interval An 1 gh UVWX CIconfidence interval Cmaxmaximum concentration ij CVOT cardiovascular outcomes trial )145 DPP-4dipeptidyl peptidase-4 .. L -4 DTR-QoLDiabetes Therapy-Related Quality of Life #$%QOL EACevent adjudication committee 9 : eGFRestimated glomerular filtration rate ~ FASfull analysis set ij GHIJ GLP-1glucagon-like peptide-1 ) : . -1 HOMA homeostatic model assessmentICHI nternational Council on Harmonisation of Technical Requirements for Pharmaceuticalsfor Human Use L EU 2 NO T MACE major adverse cardiovascular event.
5 < 9 : MedDRAM edical Dictionary for Regulatory Activities 2 I PMDAP harmaceuticals and Medical Devices Agency 2 q q PPeptide InnOvatioN for Early diabEtes tReatment, PIONEER 63a7, 01 PYEpatient-years of exposureQOLquality of life ] SGLT-2sodium-glucose co-transporter-2 1- -2 SNAC sodium N-(8-[2-hydroxybenzoyl] amino) caprylate )./8 1 SUsulphonylurea * 2 t1/2terminal half-life 7 z{ tmaxtime to maximum concentration ij TZDthiazolidinedione :2 -GI - glucosidase inhibitor - L 2 Module 8 of 2"#$% w R D U < b < s X1,2,3,4 K Kxy % U w2045 U 10%U bXR X5 #$%Ua bX WX U 6w2"#$% w < U < #.}
6 / IJ bX R X7,8,9,10 w2"#$% D 11,12w 6,12,13 V 14w#$% X K R X7 w w m jR ] U wLMUVWX#$% D 28 2017 15 wLMUV w#$% X HbA1c s #$% W X R 1000 R X LMUV #$% D u 95% s 2"#$%Uu X <#$%2 U XU w K 2"#$% D . D : d X NLJ,-Ljlj NJM Y'(wADVANCE trial UK Prospective Diabetes Study<Nj UV w <#$% bX U wnj < # : / bX R XR X6,16,17,18,19,20 < w 2"#$% DUV w U X ij U X U X # : / < 21,22,23 :&[ &'() * + w #$%2 1_w2_ 3_U X LM 2"#$% DUV w < # : / HbA1c U < R X24 0: j w2"#$% K UVWX.)
7 < X25 2"#$% 0: U b U w w UGbX < w # X UGbX w DUR UGbX <Nj X19,26,27,28,29,30 w#$%2 0: w U 2 2 X31 < # : / < w 0: U w <Y9 : 2"#$% U X K X32,33 < X,- < K clinical inertia X w=Uw2"#$% ij 3 UVWX # : / UR X R X34 w 2U X R X w,- < K =U U X32 Module 9 of 83U # : / bX R |([ w < j<Njw bXR X35,36,10 w w U2"#$% DUV U X37 <Vw DZDz % U w U2"#$% bX D X38 s Uw D dz 2"#$% UV U Xw K K #$%2 :&[ &'() * + bX ).]]
8 -1 GLP-1 m2 w # : / w w q bX D O < |([ V w w 2_ 0 39 40 ijgh _ X UwGLP-1 m2 X # < ws |([ U wGLP-1 m2U X wgh wb< 2 X R R< V 41,42w D w2"#$% UV gh <GLP-1 m2U X X43 w GLP-1UG 7 K bX <GLP-1 / X44 uRbX 1 ijgh _ wij w D L : [ ij 2 mg w2"#$% 2R w LM X LM L 2018 3 23L < gh U < 1L1 gh RbX w < U Rop _ XSNAC )./8 1 1 U _ SNAC wQ <pH U u w UGbX si K U w gh op bX45 gh _ w w w.)]]]
9 2 wY:Z _ U N _ X U wGLP-1 m2 |([ w K gh _R bX R X 2"#$% R d < / ,- ./ 01 NN9924 UV w ,-23w Kw K K ./|}9 ef LMUVWX U X,-45 b 63a745 UGbX K ef )145 CVOT UV Module 10 of 83W 2"#$% D C5D 9543 ,-45 GCPUabXL EU 2 NO T ICH 9 09:46 LMUVWX cut-off date 2018 11 2L w2 ,-2345 442745 424845 w 63a745 425745 45 w 45 ' Y M U < aExtension part is ongoing, and extension parts is not included in the applicationbphase 2/3a trial; ctrials with once-weekly semaglutide for T2D (Ozempic ); dtrial sponsored by AME: absorption, metabolism and excretion.]
10 CVOT: cardiovascular outcomes trial; FHD: first human dose; OAD: oral anti-diabetic drug; P: PIONEER; QTc: corrected QT interval; SNAC: sodium N-(8-[2-hydroxybenzoyl] amino) caprylate LMUVWX,-' YZ[\ U R Module bRV w U d <, 01 X Module 01 ' Y wij ./ 01 SNAC 45 ' Y X ; < c b Module 11 of 83, 01 wopqrwopUGbX <ghst w2"#$% Dw 2"#$% DwLM C5Dw 2^mnU b K X q w q s z bXC5 DUVWX2^mn=Kw< UC7 2 7 2R b2^7 KUa w efbX R 63a745 ' YU IJ2^mn wE K 2^mnw # : / HbA1c KZ0& Y UabX?]
