Li J, Tian H, Li Q, Wang N, Wu T, Liu Y, Ni Z, Yu H, Liang J, Luo R, Li Y, Huang L
Department of Endocrinology, State Key Lab of Biotherapy, West China Hospital of Sichuan University, Chengdu, China.
Diabetes Obes Metab. 2007 Jul;9(4):558-65. doi: 10.1111/j.1463-1326.2006.00638.x.
To evaluate the efficacy of nateglinide vs. repaglinide in blood glucose (BG) control and the effect on insulin resistance and beta-Cell function in patients with type 2 diabetes.
A randomized controlled double-blind and double-dummy multicentre clinical trial was conducted. A total of 230 Chinese patients with type 2 diabetes were enrolled in five clinical centres. The patients were divided randomly into group A [repaglinide 1.0 mg three times daily (t.i.d.), n = 115] or group B (nateglinide 90 mg t.i.d., n = 115). At baseline and end of the 12-week clinical trial, standard mixed meal tolerance tests were performed.
A total of 223 patients (96.9%) completed the trial. There was no significant difference between repaglinide and nateglinide groups in the effects of reducing fasting blood glucose (FBG), 30-, 60- and 120-min BG during 12 weeks (p > 0.05). At week 12, no significant difference was shown between the two groups in BG or haemoglobin A(1c) (HbA(1c)) (p > 0.05). However, the effect on HbA(1c) in repaglinide group was stronger than that in nateglinide group (p < 0.05). After 12-week treatment, area under the curve (AUC) of BG decreased (p < 0.05), and AUC of insulin and C-peptide (CP) increased in both groups (p < 0.05). The effects of nateglinide on AUC of BG, insulin and CP were similar to that of repaglinide (p > 0.05). There was no significant difference between the two groups in AUC of BG, insulin or CP in week 12 (p > 0.05). Furthermore, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function indexes measured by HOMA-beta, DeltaI(30)/DeltaG(30) and (DeltaI(30)/DeltaG(30))/HOMA-IR were improved significantly in both groups during 12 weeks (p < 0.05). The effects of improving HOMA-IR and beta-cell function indexes in nateglinide group were comparable with that of repaglinide group (p > 0.05).
The efficacy of repaglinide and nateglinide in FBG, postprandial glucose excursion and early-phase insulin secretion is similar. But the effect of repaglinide 1.0 mg t.i.d. on HbA(1c) is stronger than that of nateglinide 90 mg t.i.d.. This trial had shown that nateglinide and repaglinide could comparably improve insulin sensitivity and beta-cell function.
评估那格列奈与瑞格列奈在2型糖尿病患者血糖控制方面的疗效以及对胰岛素抵抗和β细胞功能的影响。
进行了一项随机对照双盲双模拟多中心临床试验。共有230例中国2型糖尿病患者在5个临床中心入组。患者被随机分为A组[瑞格列奈1.0毫克，每日三次（t.i.d.），n = 115]或B组（那格列奈90毫克，每日三次，n = 115）。在基线和12周临床试验结束时，进行标准混合餐耐量试验。
共有223例患者（96.9%）完成试验。瑞格列奈组与那格列奈组在12周内降低空腹血糖（FBG）、30、60和120分钟血糖方面的效果无显著差异（p > 0.05）。在第12周时，两组在血糖或糖化血红蛋白A1c（HbA1c）方面无显著差异（p > 0.05）。然而，瑞格列奈组对HbA1c的影响强于那格列奈组（p < 0.05）。12周治疗后，两组血糖曲线下面积（AUC）均降低（p < 0.05），胰岛素和C肽（CP）的AUC均升高（p < 0.05）。那格列奈对血糖、胰岛素和CP的AUC的影响与瑞格列奈相似（p > 0.05）。在第12周时，两组在血糖、胰岛素或CP的AUC方面无显著差异（p > 0.05）。此外，两组在12周内胰岛素抵抗的稳态模型评估（HOMA-IR）以及通过HOMA-β、ΔI(30)/ΔG(30)和(ΔI(30)/ΔG(30))/HOMA-IR测量的β细胞功能指标均显著改善（p < 0.05）。那格列奈组改善HOMA-IR和β细胞功能指标的效果与瑞格列奈组相当（p > 0.05）。
瑞格列奈和那格列奈在空腹血糖、餐后血糖波动和早期胰岛素分泌方面的疗效相似。但瑞格列奈1.0毫克每日三次对HbA1c的影响强于那格列奈90毫克每日三次。本试验表明，那格列奈和瑞格列奈在改善胰岛素敏感性和β细胞功能方面具有相当的效果。
