那格列奈治疗2型糖尿病的有效性和安全性的随机、双盲、对照研究

目的观察那格列奈治疗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50例,试验组(那格列奈组)和对照组(瑞格列奈组)各25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2.45%,空腹血糖下降0.82mmol/L,餐后2h血糖下降3.59mmol/L;对照组HbA1c下降3.10%,空腹血糖下降1.77mmol/L,餐后2h血糖下降4.33mmol/L(均P<0.01)。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。结论那格列奈可使HbA1c、空腹血糖、餐后2h血糖显著下降,且安全性和耐受性较好。

The Random, Double-blind and Controlled Study on the Efficacy and Safety of Nateglinide in the Treatment of Type 2 Diabetes

Objective To investigate the efficacy and safety of Nateglinide in the treatment of type 2 diabetes. Methods 50 patients with type 2 diabetes were enrolled and allocated randomly in two groups, the test group (neteglinide group, 25 cases) and the control group (repaglinide group, 25 cases). A clinical study of 12 weeks period was conducted using the random, double-blind, parallel-controlled method. Results 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 2.45%, 0.82 mmol/L, 3.59 mmol/L respectively in the twelfth week, while the HbA1c, FBG, 2 h PBG in the control group decreased 3.10%, 1.77 mmol/L, 4.33 mmol/L respectively( P <0.01). There were no significant difference between the two groups in the comparison of the above indexes. During the treatment of 12 weeks, there were no change of clinical significance found in both life signs and laboratory tests. Conclusion Nateglinide can make the HbA1c, FBG, 2 h PBG significantly decreased and it has an excellent safety and tolerance.