那格列奈片治疗2型糖尿病的多中心随机双盲平行对照临床试验

Randomized, double-blind, double-dummy, controlled clinical trial of nateglinide in the treatment of type 2 diabetes

目的 以瑞格列奈为对照,评价那格列奈治疗2型糖尿病的疗效和安全性。方法 用多中心随机双盲双模拟平行对照的试验设计,观察了228例2型糖尿病病人,其中那格列奈组111例,瑞格列奈组117例。结果 与基础值比较,治疗12周后那格列奈组空腹血糖(FBG)、餐后2h血糖(PBG)及糖化血红蛋白(HbA1c)分别下降(1.25±1.79) mmol.L-1,(4.03±2.82) mmol.L-1和(0.56±1.07)%;瑞格列奈组病人FBG、PBG及HbA1c分别下降(1.54±1.49)mmol.L-1,(3.79±3.44) mmol.L-1和(0.53±0.97)%;2组下降各指标比较均有显著性差异,而2组间比较无显著性差异。2组药物不良反应发生率比较无统计学差异。结论 那格列奈是治疗2型糖尿病有效和安全的药物。

Objective To evaluate the efficacy and safety of nateglinide in thetreatment of type 2 diabetes mellitus patients. Methods A randomized, double-blind,double-dummy, repaglinide-controlled and multicenter clinical trial was conducted.Two hundreds twenty eight patients with type 2 diabetes mellitus were enrolled inthis study, in which 111 patients received nateglinide(trial) and 117 patients receivedrepaglinide(control), for 12 weeks. Results Compared with the baseline, the fastingblood glucose (FBG), 2 hour postprandial blood glucose (PBG) and HbA1c levelsin two groups were significantly reduced after 12-week treatment (P<0.01). Themean reductions of FBG, PBG and HbA1c levels were (1.25±1.79) mmol.L-1,(4.03±2.82) mmol.L-1,(0.56±1.07)% respectively in nateglinide group, and(1.54±1.49) mmol.L-1,(3.79±3.44) mmol.L-1, (0.53±0.97)% respectively inrepaglinide group. The differences in reductions of FBG, PBG and HbA1c levelbetween the two groups were not statistically significant. The incidence of adverseeffects in two groups was similar. Laboratory tests did not significantly changeafter treatment. Conclusion Nateglinide is an efficacy and a safety in the treatmentof type 2 diabetes mellitus.