罗赫曼森K, Kipnes M E, Fanurik D,哈塔米H,斯坦P
疗效和安全性的dipeptidyl peptidase-4抑制剂,sitagliptin,在2型糖尿病患者控制不足glimepiride单独或glimepiride和二甲双胍。
糖尿病ob金属底座。2007年9月,9 (5):733 - 45。Epub 2007年6月26日。
目的:评估24周治疗的疗效和安全性,sitagliptin高度选择性的每日一次口服dipeptidyl peptidase-4 (DPP-4)抑制剂,在2型糖尿病患者血糖控制不足(糖化血红蛋白(HbA (1 c)) > = 7.5%
或= 4毫克/天)单药治疗,229人在glimepiride(> = 4毫克/天)+二甲双胍(> = 1500毫克/天)联合治疗。双盲治疗期间患者超过预先确定的血糖阈值提供了开放的救援疗法(吡格列酮),直到研究结束。主要功效分析评估HbA (1 c)的变化从基线到24周。次要疗效端点包括空腹血糖(台塑),2 h餐后葡萄糖和脂质测量。结果:平均基线sitagliptin HbA (1 c)是8.34%和安慰剂组。24周后,sitagliptin HbA (1 c)减少了0.74% (p < 0.001)相对于安慰剂。在病人的子集glimepiride +二甲双胍,sitagliptin HbA (1 c)减少了0.89%相对于安慰剂,而减少0.57%在病人的子集glimepiride孤单。添加sitagliptin台塑减少了20.1 mg / dl (p < 0.001),增加assessment-beta内稳态模型,β细胞功能的一个标志,12%相对于安慰剂组(p < 0.05)。在病人吃饭耐量试验(n = 134), sitagliptin下降2 h餐后葡萄糖(PPG) 36.1 mg / dl相对于安慰剂组(p < 0.001)。添加sitagliptin一般耐受性良好,尽管有更高的发病率总体(60比47%)和与毒品有关的不良经历(AEs)(15比7%)sitagliptin组比安慰剂组。 This was largely because of a higher incidence of hypoglycaemia AEs (12 vs. 2%, respectively) in the sitagliptin group compared with the placebo group. Body weight modestly increased with sitagliptin relative to placebo (+0.8 vs. -0.4 kg; p < 0.001). CONCLUSIONS: Sitagliptin 100 mg once daily significantly improved glycaemic control and beta-cell function in patients with type 2 diabetes who had inadequate glycaemic control with glimepiride or glimepiride plus metformin therapy. The addition of sitagliptin was generally well tolerated, with a modest increase in hypoglycaemia and body weight, consistent with glimepiride therapy and the observed degree of glycaemic improvement.