Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Graduate School of Medicine, 6-11-1 Omori Nishi, Ota-ku, Tokyo 143-8541, Japan.
Department of Diabetes, Endocrinology, Metabolism and Rheumatology, Tokyo Medical University, 6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
Diabetes Res Clin Pract. 2021 Feb;172:108647. doi: 10.1016/j.diabres.2020.108647. Epub 2020 Dec 24.
This study investigated the hypoglycemia risk in people with type 2 diabetes (T2D) who initiated or switched to insulin glargine 300 U/mL (Gla-300) by stratifying them by age and renal function.
We examined data from 4621 people with T2D (1227 insulin-naïve and 3394 insulin-experienced) of the X-STAR study, a prospective, observational, 12-month study conducted from December 2015 to August 2018 in Japan. Participants were stratified by age (<65, 65 to <75, and ≥75 years) and estimated glomerular filtration rate (eGFR) (≥90, 60 to <90, 30 to <60, and <30 mL/min/1.73 m). Hypoglycemia was defined according to the Ministry of Health, Labour and Welfare manual of Japan.
No apparent increase in the proportion of people who experienced hypoglycemia was found in all subgroups. The proportions were 2.9-3.5% and 2.7-5.2% of insulin-naïve and insulin-experienced people, respectively, for age subgroups, and 2.4-4.7% and 4.6-4.8%, respectively, for eGFR subgroups. The result was similar for HbA1c levels below and at or above 7.0% in all age subgroups.
Our study found no apparent increase in the hypoglycemia risk in people with older age and renal impairment who were administered Gla-300. These results would provide reassuring information on Gla-300 use.
本研究通过分层分析年龄和肾功能，调查了起始或转换为甘精胰岛素 300U/mL（Gla-300）的 2 型糖尿病（T2D）患者的低血糖风险。
我们检查了 X-STAR 研究中 4621 名 T2D 患者（1227 名胰岛素初治患者和 3394 名胰岛素经验患者）的数据，这是一项前瞻性、观察性的 12 个月研究，于 2015 年 12 月至 2018 年 8 月在日本进行。参与者按年龄（<65、65-<75 和≥75 岁）和估算肾小球滤过率（eGFR）（≥90、60-<90、30-<60 和<30 mL/min/1.73 m）分层。低血糖根据日本厚生劳动省手册定义。
在所有亚组中，均未发现经历低血糖的患者比例明显增加。胰岛素初治患者的比例分别为年龄亚组的 2.9-3.5%和 2.7-5.2%，胰岛素经验患者的比例分别为年龄亚组的 2.4-4.7%和 4.6-4.8%。对于所有年龄亚组中 HbA1c 水平低于和等于 7.0%的患者，结果相似。
我们的研究发现，在接受 Gla-300 治疗的年龄较大和肾功能受损的患者中，低血糖风险没有明显增加。这些结果将为 Gla-300 的使用提供令人安心的信息。
