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華領醫藥-B(02552.HK):完成多扎格列艾汀與二甲雙胍聯合用藥的III期臨牀試驗
格隆匯 12-18 06:51

格隆匯 12 月 18日丨華領醫藥-B(02552.HK)發佈公告,公司於2020年12月18日宣佈多扎格列艾汀(dorzagliatin)第二項III期註冊臨牀研究DAWN(黎明研究,也稱HMM0302)的核心結果。公司已於2020年6月公佈了其首個III期註冊臨牀研究SEED(播種研究,也稱HMM0301)的核心資料。在超過1,200例中國患者中,公司已成功完成兩項多扎格列艾汀53周III期註冊臨牀研究,包括52周治療和後續1周安全性隨訪。雖然研究是在新冠疫情期間完成的,但試驗資料和試驗結果都保持了一貫的高品質。多扎格列艾汀是一款全新機制、全球首創、雙重作用的葡萄糖激酶啟動劑(GKA)類口服新藥,旨在通過修復2型糖尿病患者的血糖穩態控制糖尿病漸進性、退變性疾病發展。

DAWN研究的關鍵核心研究亮點包括:針對二甲雙胍足量治療(1,500mg╱日)失效的中國2型糖尿病患者,在黎明研究的24周和52周治療期間,多扎格列艾汀(Dorzagliatin)均表現出良好的安全性和耐受性;不同於很多其它口服糖尿病藥物,多扎格列艾汀與二甲雙胍聯合用藥不會增加低血糖事件發生率:整個52黎明研究期間,低血糖事件發生率(血糖低於3mmol/L)低於1%。

此外,24周治療期結束時,評估主要療效終點,多扎格列艾汀治療組糖化血紅蛋白(HbA1c)較基線降低1.02%,餐後兩小時血糖值(2h-PPG)較基線顯著降低5.45mmol/L,具有顯著的統計學意義,p值小於0.0001;在降低糖化血紅蛋白方面,多扎格列艾汀能夠快速起效,24周和52周治療期間均持續有效;在平均糖尿病患病史近6年,且二甲雙胍足量治療(1,500mg╱日)失效的患者中,黎明研究顯示,相比於安慰劑對照組,多扎格列艾汀治療組患者的HOMA2-β顯著增加、HOMA2-IR降低,表明多扎格列艾汀能夠持續改善β細胞功能和胰島素抵抗。類似的結果也出現在播種研究中,該試驗平均糖尿病患病史為1年,且患者從未接受過糖尿病藥物治療;首次由中國生物技術公司推出全球首創的口服治療新藥-葡萄糖增敏劑,其全新作用機制直擊2型糖尿病的根本病因,可以改善胰島素抵抗和β細胞功能。

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