1 Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine , Tokyo, Japan .
2 Tsuruoka Kyoritu Hospital , Yamagata, Japan .
Diabetes Technol Ther. 2017 Aug;19(8):457-462. doi: 10.1089/dia.2017.0028. Epub 2017 Jun 12.
Not only within-day glycemic variability but also day-to-day glycemic variability is a risk factor for diabetic patients. However, the ways of controlling day-to-day glycemic variability are unclear. We hypothesized that the durability of basal insulin plays an important role in controlling day-to-day glycemic variability in type 2 diabetes patients, and we therefore aimed to evaluate whether glargine U300, which exhibits prolonged absorption compared with glargine U100 but the same composition as glargine U100, would lead to improved day-to-day glycemic variability.
This was a single-center, randomized, open-label, crossover study in type 2 diabetes patients using basal insulin therapy. After switching from 4 weeks of treatment with glargine U100 or U300, the patients performed continuous glucose monitoring (CGM) for 72 h in an environment with routine activities and mealtimes. The mean of daily difference (MODD) was assessed as day-to-day glycemic variability.
We enrolled 22 patients, and 17 patients completed the study. The MODD assessed as day-to-day glycemic variability was significantly lower with glargine U300 than with glargine U100 (1.8 ± 0.6 mmol/L vs. 2.4 ± 0.9 mmol/L, P = 0.006). No significant difference was observed in short-term glycemic variability between the two glargine formulations as measured by the standard deviation, coefficient of variation, mean amplitude of glucose excursion.
Compared with glargine U100 treatment, glargine U300 treatment improved the MODD as assessed by CGM in type 2 diabetes patients. These findings suggest that the durability of basal insulin may be associated with day-to-day glycemic variability in type 2 diabetes patients.
不仅日内血糖变异性，而且日间血糖变异性也是糖尿病患者的一个危险因素。然而，控制日间血糖变异性的方法尚不清楚。我们假设基础胰岛素的作用持续时间在控制 2 型糖尿病患者的日间血糖变异性方面起着重要作用，因此我们旨在评估与甘精胰岛素 U100 相比吸收更持久但组成相同的甘精胰岛素 U300 是否会导致日间血糖变异性得到改善。
这是一项在使用基础胰岛素治疗的 2 型糖尿病患者中进行的单中心、随机、开放标签、交叉研究。在转换为甘精胰岛素 U100 或 U300 治疗 4 周后，患者在常规活动和进餐时间的环境中进行了 72 小时的连续血糖监测（CGM）。平均每日差异（MODD）被评估为日间血糖变异性。
我们共纳入 22 名患者，其中 17 名患者完成了研究。与甘精胰岛素 U100 相比，甘精胰岛素 U300 的 MODD （日间血糖变异性）显著降低（1.8±0.6mmol/L 与 2.4±0.9mmol/L，P=0.006）。两种甘精胰岛素制剂的短期血糖变异性通过标准差、变异系数、血糖波动幅度无显著差异。
与甘精胰岛素 U100 治疗相比，甘精胰岛素 U300 治疗可改善 2 型糖尿病患者 CGM 评估的 MODD。这些发现表明，基础胰岛素的作用持续时间可能与 2 型糖尿病患者的日间血糖变异性有关。
