国产那格列奈治疗2型糖尿病随机双盲平行对照多中心临床试验

Randomized Controlled Multicenter Clinical trial of Domestic Nateglinide in the Treatment of Type 2 Diabetes

目的观察国产那格列奈治疗2型糖尿病的有效性和安全性。方法随机入组2型糖尿病患者240例,试验组(那格列奈组)和对照组(瑞格列奈组)各120例。采用随机、双盲、那格列奈与瑞格列奈平行对照的研究方法,进行为期12周的临床研究。结果与(基础值0周)比较,12周试验组HbA1c下降1.53%,空腹血糖下降1.39mmol/L,餐后2h血糖下降3.92mmol/L;对照组糖化血红蛋白(HbA1c)下降1.48%,空腹血糖下降1.68mmol/L,餐后2h血糖下降3.51mmol/L。治疗12周中,生命体征、实验室检查指标均未见有临床意义的变化。结论国产那格列奈可使2型糖尿病人HbA1c、空腹血糖、餐后2h血糖显著下降,且安全性和耐受性较好,其临床作用不次于瑞格列奈。

Objective To investigate the efficacy and safety of domestic Nateglinide in the treatment of type 2 diabetes. Methods 240 patients with type 2 diabetes were enrolled and divided randomly into two groups, the test greup（neteglinide group, 120 cases）and the control group （repaglinide group, 120 cases）. A clinical study of 12 weeks period was conducted using the random, double blind, parallel controlled method. Resuits Compared with the baseline value（0 week）, the HbA1c, fasting glucose（FBG）,2 h post-meal glucose（2 h PBG）in the test group decreased by 1.53%, 1.39 mmol/L and 3.92 mmol/L respectively in the twelfth week,while the HbA1c,FBG,2 h PBG in the control group decreased 1.48%, 1.68 mmol/L and 3.51 mmol/L respectively. There was no significant difference in the comparison of the above indexes between the two groups. During the treatment of 12 weeks, there were no change of clinical significance found in beth life signs and laboratory tests. Conclusion Domestic Nateglinide can reduce significantly the HbA1c,FBG,2 h PBG of patients with type 2 diabetes and has an excellent safety and tolerance.