Gao Y, Li G, Li Y, Guo X, Yuan G, Gong Q, Yan L, Zheng Y, Zhang J
Department of Endocrinology, Peking University First Hospital, Beijing, China.
Int J Clin Pract. 2008 Sep;62(9):1344-51. doi: 10.1111/j.1742-1241.2008.01850.x. Epub 2008 Jul 24.
To compare the 2-h postprandial blood glucose (PPBG) excursion following a standard test meal in insulin-requiring patients with diabetes treated twice daily with human insulin mix 50 vs. insulin lispro mix 50 (LM50).
This was a multicentre, randomised, open-label, crossover comparison of two insulin treatments for two 12-week treatment periods in 120 Chinese patients. One- and 2-h PPBG and excursion values were obtained following a standardised test meal. Fasting blood glucose (FBG), haemoglobin A1c (HbA1c), insulin dose, rate of hypoglycaemia and safety data were obtained. A crossover analysis using SAS Proc MIXED was employed.
Mean 2-h PPBG excursion decreased from 6.32 +/- 3.07 mmol/l at baseline to 3.47 +/- 2.97 mmol/l at end-point in the LM50 group, and from 6.31 +/- 2.88 at baseline to 5.02 +/- 3.32 mmol/l at end-point in the human insulin mix 50 group (p < 0.001). Two-hour PPBG (p = 0.004) and 1-h PPBG excursion (p < 0.001) were significantly lower with LM50 as compared with human insulin mix 50. Both treatment groups were equivalent for HbA1c control, 1-h PPBG and insulin dose requirements. Mean FBG was higher with LM50 than with human insulin mix 50 (p = 0.023). The overall incidence of treatment-emergent adverse events and hypoglycaemia rate per 30 days were similar between treatment groups.
Insulin lispro mix 50 provided better postprandial glycaemic control compared with human insulin mix 50 while providing the convenience of injecting immediately before meals. Both treatments were generally well tolerated by all randomly assigned patients.
比较每日两次接受人胰岛素50混合制剂与赖脯胰岛素50混合制剂(LM50)治疗的糖尿病胰岛素依赖患者在标准试验餐后2小时餐后血糖(PPBG)的波动情况。
这是一项多中心、随机、开放标签的交叉比较研究,对120例中国患者进行两个为期12周的胰岛素治疗周期。在标准化试验餐后获取1小时和2小时的PPBG及波动值。获取空腹血糖(FBG)、糖化血红蛋白(HbA1c)、胰岛素剂量、低血糖发生率及安全性数据。采用SAS Proc MIXED进行交叉分析。
LM50组2小时PPBG波动均值从基线时的6.32±3.07 mmol/L降至终点时的3.47±2.97 mmol/L,人胰岛素50混合制剂组从基线时的6.31±2.88降至终点时的5.02±3.32 mmol/L(p<0.001)。与使用人胰岛素50混合制剂相比,LM50组的2小时PPBG(p=0.004)和1小时PPBG波动(p<0.001)显著更低。两组在HbA1c控制、1小时PPBG及胰岛素剂量需求方面相当。LM50组的平均FBG高于人胰岛素50混合制剂组(p=0.023)。治疗组之间治疗期间出现的不良事件总发生率及每30天的低血糖发生率相似。
与人类胰岛素50混合制剂相比,赖脯胰岛素50混合制剂在提供餐前进针便利性的同时,能更好地控制餐后血糖。所有随机分配的患者对两种治疗的耐受性总体良好。