Murata Takashi, Husemoen Lise Lotte N, Nemoto Satoko, Matsuhisa Munehide
Department of Clinical Nutrition, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Diabetol Int. 2023 Aug 18;15(1):76-85. doi: 10.1007/s13340-023-00657-7. eCollection 2024 Jan.
Insulin degludec (degludec) is a basal insulin with a long duration of action. This post-marketing surveillance study monitored safety and glycemic control during use of degludec for 3 years in normal clinical practice in Japan.
This multicenter, open-label, observational study included patients with diabetes receiving degludec in Japan between 2013 and 2019. The primary outcome was incidence of adverse events occurring over 3 years of treatment. The pre-specified, secondary outcomes were severe hypoglycemic episodes and changes in HbA1c and fasting plasma glucose levels.
Of 4167 patients enrolled, 4022 were included in the safety assessments and 3918 in the assessments of glycemic control. Mean age was 58.9 years; 74.1% of patients had type 2 diabetes, and mean HbA1c at baseline was 8.7%. Adverse events and serious adverse events were observed in 19.1% and 8.9% of patients, respectively. Cardiac disorders and neoplasms were reported in 2.0% and 1.8% of patients, respectively, with the majority of these incidents reported as serious adverse events. Adverse drug reactions were seen in 8.0% of patients, mainly hypoglycemia. Hypoglycemic events were observed in 5.6% of patients, and severe hypoglycemic events in 1.7%. No serious allergic or injection-site reactions were seen. Respective changes (from baseline to 3 years' observation) in HbA1c and fasting plasma glucose levels were - 0.55% and - 36.3 mg/dL, and 19.6% of patients reached HbA1c < 7.0%.
Using degludec for 3 years in normal clinical practice had a good safety and tolerability profile. Improvements in glycemic control were also seen.
The online version contains supplementary material available at 10.1007/s13340-023-00657-7.
德谷胰岛素（degludec）是一种长效基础胰岛素。这项上市后监测研究在日本正常临床实践中对德谷胰岛素使用3年期间的安全性和血糖控制情况进行了监测。
这项多中心、开放标签的观察性研究纳入了2013年至2019年期间在日本接受德谷胰岛素治疗的糖尿病患者。主要结局是治疗3年内发生不良事件的发生率。预先设定的次要结局是严重低血糖事件以及糖化血红蛋白（HbA1c）和空腹血糖水平的变化。
在纳入的4167例患者中，4022例纳入安全性评估，3918例纳入血糖控制评估。平均年龄为58.9岁；74.1%的患者患有2型糖尿病，基线时平均HbA1c为8.7%。分别有19.1%和8.9%的患者发生不良事件和严重不良事件。分别有2.0%和1.8%的患者报告患有心脏疾病和肿瘤，其中大多数事件报告为严重不良事件。8.0%的患者出现药物不良反应，主要是低血糖。5.6%的患者发生低血糖事件，1.7%的患者发生严重低血糖事件。未观察到严重过敏或注射部位反应。HbA1c和空腹血糖水平从基线到3年观察期的各自变化分别为-0.55%和-36.3mg/dL，19.6%的患者HbA1c＜7.0%。
在正常临床实践中使用德谷胰岛素3年具有良好的安全性和耐受性。血糖控制也有所改善。
在线版本包含可在10.1007/s13340-023-00657-7获取的补充材料。
