Sabuwar Makullin Maganin Ciwon Ciwon sukari

Farfesa Kyong Soo Park na Asibitin Jami'ar Kasa ta Seoul a matsayin mai gudanar da bincike da manyan masu bincike daga cibiyoyi 22 sun shiga cikin gwaji na asibiti na 3 na Enavogliflozin a matsayin monotherapy (ENHANCE-A binciken). An gudanar da binciken a matsayin mai yawa, bazuwar, makafi biyu, sarrafa wuribo, da gwajin tabbatarwa na warkewa wanda ya ƙunshi marasa lafiya 160 da nau'in ciwon sukari na 2. Babban ƙarshen ƙarshen shine bincika bambanci tsakanin ƙungiyar Enavogliflozin da ƙungiyar placebo a cikin canjin asali na haemoglobin glycated (HbA1c). Dangane da rahoton topline, an lura da farko don zama 0.99% p a cikin makonni 24 tun lokacin da aka gudanar da samfuran bincike, wanda ya tabbatar da mahimmancin ƙididdiga (P-darajar <0.001). HbA1c, wanda shine samfurin ƙarshe na haemoglobin wanda aka haɗa tare da glucose na jini, ma'aunin gwal ne don tantance tsananin ciwon sukari.

Bugu da ƙari, an sami sakamako mai kyau na binciken wanda aka lura a cikin wani gwaji na asibiti na 3 na hadewar Enavogliflozin tare da metformin ta Daewoong Pharmaceutical (ENHANCE-M). Farfesa Gun Ho Yoon na Jami'ar Katolika ta Koriya ta Kudu da Asibitin St. Mary ne ya gudanar da binciken ENHANCE-M a matsayin mai gudanar da bincike da manyan masu bincike daga cibiyoyi 23. An gudanar da gwajin tare da marasa lafiya 200 da ke da nau'in ciwon sukari na 2 waɗanda ba su da isasshen ikon sarrafa glucose na jini tare da Metformin. Dangane da sakamakon game da canjin asali na HbA1c. Rukunin marasa lafiya waɗanda aka gudanar tare da Enavogliflozin tare tare da Metformin sun sami nasarar nuna rashin ƙarancin sa ga rukunin waɗanda aka gudanar tare da Dapagliflozin tare da Metformin lokaci guda. Hakanan an tabbatar da sakamakon aminci a cikin rukunin da aka gudanar tare da Enavogliflozin saboda ba a sami wasu munanan abubuwan da ba a zata ba ko kuma mummunan halayen ƙwayoyi ya faru.

Masu binciken sun ce, "Gwajin asibiti na kashi 3 na Enavogliflozin monotherapy (ENHANCE-A) da Metformin hade far (ENHANCE-M) tare da jimlar mahalarta Koriya 360 sun nuna ingantaccen tasirin rage glucose da amincin maganin. Enavogliflozin zai zama kyakkyawan zaɓi na magani ga marasa lafiya da ke da nau'in ciwon sukari na 2 idan an tabbatar da sakamako iri ɗaya daga sauran hanyoyin haɗin gwiwa.

Kamar yadda aka samu sakamako mai mahimmanci daga gwaje-gwajen guda biyu don maganin monotherapy da Metformin, Daewoong yana farin cikin fitar da sabon mai hana SGLT-2 a karon farko a Koriya ta Kudu. Daewoong ya yi niyya nan da nan don neman sabon amincewar miyagun ƙwayoyi kuma don ƙaddamar da ba kawai Enavogliflozin ba amma Enavogliflozin / Metformin tsayayyen kashi-haɗin-haɗin-haɗin (FDC) ta 2023. A halin yanzu, Daewoong an riga an amince da shi don nazarin lokaci-1 don gwada nazarin bioequivalence na bioequivalence. FDC na Enavogliflozin da Metformin a cikin Janairu 2022.

"Tare da nasarar gwaje-gwajen asibiti na baya-bayan nan, ana sa ran za mu samar da majinyata na gida sabon maganin ciwon sukari na kasar nan gaba kadan," in ji Sengho Jeon, Shugaba na Daewoong Pharmaceutical. "Za mu yi ƙoƙari don sakin magungunan na gaba tare da taimakawa waɗanda ke fama da ciwon sukari da rikice-rikice, yayin da muke samun ci gaba da haɓakar kamfanin."