Takahara Mitsuyoshi, Shiraiwa Toshihiko, Katakami Naoto, Matsuoka Taka-Aki, Shimomura Iichiro
1 Department of Metabolic Medicine, Osaka University Graduate School of Medicine , Suita, Osaka, Japan .
Diabetes Technol Ther. 2014 Oct;16(10):633-9. doi: 10.1089/dia.2014.0075. Epub 2014 Jun 20.
Glucose fluctuation often remains to be corrected under basal-supported oral therapy. We investigated the efficacy of adding once-daily rapid-acting insulin in Japanese diabetes patients treated with basal-supported oral therapy.
In this 8-week, parallel-group, randomized, open-label trial, 62 Japanese adults with type 2 diabetes treated with insulin glargine and 50 mg of sitagliptin were randomized into the following two arms: the single-bolus group, in which once-daily insulin glulisine was initiated at a main meal at a fifth (i.e., 20%) the dose of insulin glargine, and the control group, in which the dose of sitagliptin was maximized to 100 mg. The primary end point was the change of glycemic fluctuation assessed with the M-value.
Baseline hemoglobin A1c levels, mean blood glucose profiles, and M-value were 7.2 ± 0.6%, 9.3 ± 1.7 mmol/L, and 21 ± 13 units, respectively. At the end of the study, the single-bolus group had a greater reduction of M-value than the control group (P=0.02); the difference was 6.5 units (95% confidence interval, 1.1-11.9 units). The single-bolus group also had a greater reduction of mean blood glucose levels (P=0.01). There were no significant differences in the incidence of hypoglycemia or the weight change between the two groups (P>0.05).
Adding once-daily insulin glulisine was more effective in controlling the glycemic fluctuation in Japanese type 2 diabetes patients treated with insulin glargine together with sitagliptin.
在基础胰岛素联合口服降糖药治疗下，血糖波动往往仍有待纠正。我们研究了在接受基础胰岛素联合口服降糖药治疗的日本糖尿病患者中加用每日一次速效胰岛素的疗效。
在这项为期8周的平行组、随机、开放标签试验中，62例接受甘精胰岛素和50毫克西格列汀治疗的日本2型糖尿病成年患者被随机分为以下两组：单剂量推注组，在主餐时开始每日一次注射赖脯胰岛素，剂量为甘精胰岛素的五分之一（即20%）；对照组，将西格列汀剂量增至最大100毫克。主要终点是用M值评估的血糖波动变化。
基线糖化血红蛋白水平、平均血糖谱和M值分别为7.2±0.6%、9.3±1.7毫摩尔/升和21±13单位。研究结束时，单剂量推注组的M值降低幅度大于对照组（P=0.02）；差异为6.5单位（95%置信区间，1.1 - 11.9单位）。单剂量推注组的平均血糖水平降低幅度也更大（P=0.01）。两组间低血糖发生率或体重变化无显著差异（P>0.05）。
在接受甘精胰岛素联合西格列汀治疗的日本2型糖尿病患者中，加用每日一次赖脯胰岛素在控制血糖波动方面更有效。
