智通财经APP讯，石药集团(01093)发布公告，集团开发的普卢格列汀二甲双胍缓释片已获中华人民共和国国家药品监督管理局批准，可在中国开展临床试验。
该产品为全球首款获批临床的由普卢格列汀和盐酸二甲双胍组成的新复方制剂。普卢格列汀为二肽基肽酶-4(DPP-4)抑制剂，通过抑制DPP-4，使内源性活性胰高血糖素样肽-1(GLP-1)水平升高，从而增强β细胞和α细胞对葡萄糖的敏感性，增加葡萄糖刺激的胰岛素分泌，并增强葡萄糖对胰高血糖素分泌的抑制作用，进而改善高血糖。二甲双胍是一种双胍类药物，可改善2型糖尿病患者糖耐量，并降低基础血糖和餐后血糖。
本次获批的临床适应症为配合饮食和运动治疗，用于二甲双胍单药治疗控制不佳或正在接受普卢格列汀与二甲双胍联合治疗的成人2型糖尿病患者。与单药治疗2型糖尿病的产品相比，该产品安全性和耐受性良好，具有较高的临床开发价值。
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