Manipal Academy of Higher Education, Department of Endocrinology, Kasturba Medical College, Manipal, India.
Diabetes Obes Metab. 2024 Mar;26(3):1069-1081. doi: 10.1111/dom.15408. Epub 2024 Jan 8.
Insulin icodec is a novel ultra-long action basal insulin analogue designed for once-weekly administration. With the merit of once-a-week administration, it promises better adherence and greater treatment satisfaction because of reduced injection frequency. The purpose of this study was to ascertain the efficacy and safety of once-weekly insulin icodec in comparison with other basal insulin analogues in the management of type 2 diabetes.
The PRISMA guidelines were followed during the conduct of this study. For the eligible studies, five databases and ClinicalTrials.gov were screened until July 2023. All randomized controlled trials comparing the efficacy and safety of insulin icodec in type 2 diabetes versus other insulin analogues were included. The extracted data were then analysed for meta-analysis using RevMan 5.3 software.
Five clinical trials with 3764 participants were included. The meta-analysis showed that once-weekly insulin icodec had higher glycated haemoglobin (HbA1c) reduction [mean difference -0.17%, 95% confidence interval (CI; -0.28 to -0.06), p = .003], with no significant difference in fasting plasma glucose compared with other insulin analogues. HbA1c achievement <7% [odds ratio 1.51, 95% CI (1.14-1.99), p = .004] and HbA1c achievement <7% without hypoglycaemia [odds ratio 1.45, 95% CI (1.26-1.67), p < .00001] were observed in higher proportions with insulin icodec compared with the comparator group. The percentage of time spent in the target glycaemic range was comparatively similar between insulin icodec and the comparator [mean difference 2.42%, 95% CI (0.01-4.84), p = .05]. There was a significantly higher incidence of level 1 hypoglycaemia with insulin icodec but no significant difference was seen for the incidence of levels 2, 3 and combined 2/3 hypoglycaemia. Any adverse events and adverse events related to basal insulin were comparably similar in insulin icodec and comparators. The subgroup analysis of once-weekly insulin icodec with individual insulin analogues (glargine U100 and degludec) showed that insulin icodec had similar efficacy with insulin glargine U100 but superior efficacy with higher HbA1c reduction with insulin icodec compared with insulin degludec. The safety profile was comparable between insulin icodec and glargine U100, whereas insulin icodec reported higher incidence of hypoglycaemia events and any adverse events when compared with degludec.
Once-weekly insulin icodec showed a better HbA1c reduction with a higher proportion of patients achieving HbA1c targets in comparison with once-daily basal insulin analogues. They were no major safety concerns with respect to hypoglycaemia or adverse events.
胰岛素icodec 是一种新型的超长效基础胰岛素类似物，设计用于每周一次给药。由于注射频率降低，每周一次给药具有更好的依从性和更高的治疗满意度。本研究的目的是确定每周一次给予胰岛素 icodec 与其他基础胰岛素类似物在 2 型糖尿病管理中的疗效和安全性。
在进行这项研究时，遵循了 PRISMA 指南。对符合条件的研究，筛选了五个数据库和 ClinicalTrials.gov，直到 2023 年 7 月。所有比较胰岛素 icodec 与其他胰岛素类似物在 2 型糖尿病中的疗效和安全性的随机对照试验均被纳入。然后使用 RevMan 5.3 软件对提取的数据进行荟萃分析。
纳入了五项包含 3764 名参与者的临床试验。荟萃分析显示，每周一次给予胰岛素 icodec 可显著降低糖化血红蛋白（HbA1c）[平均差值-0.17%，95%置信区间（CI）：-0.28 至-0.06），p=0.003]，与其他胰岛素类似物相比，空腹血糖无显著差异。与对照组相比，胰岛素 icodec 组有更高比例的患者达到 HbA1c<7%[比值比（OR）1.51，95%CI（1.14-1.99），p=0.004]和 HbA1c<7%且无低血糖[OR 1.45，95%CI（1.26-1.67），p<0.00001]。与对照组相比，胰岛素 icodec 组的目标血糖范围内时间比例更高[平均差值 2.42%，95%CI（0.01-4.84），p=0.05]。胰岛素 icodec 组发生 1 级低血糖的发生率显著升高，但 2 级、3 级和联合 2/3 级低血糖的发生率无显著差异。胰岛素 icodec 和对照组的任何不良事件和与基础胰岛素相关的不良事件相似。胰岛素 icodec 与个别胰岛素类似物（甘精 U100 和地特胰岛素）的亚组分析显示，与甘精 U100 相比，胰岛素 icodec 具有相似的疗效，但与地特胰岛素相比，胰岛素 icodec 可显著降低 HbA1c。胰岛素 icodec 的安全性与甘精 U100 相似，而与地特胰岛素相比，胰岛素 icodec 报告低血糖事件和任何不良事件的发生率更高。
与每日一次的基础胰岛素类似物相比，每周一次给予胰岛素 icodec 可显著降低 HbA1c，达到 HbA1c 目标的患者比例更高。在低血糖或不良事件方面，没有出现重大安全性问题。
