Guo Lixin, Chen Liming, Zhao Fan, Liu Xiaoyun, Ding Hongcheng, Wang Kun, Zhong Xing, Shankarappa Vinay Babu, Chaudhary Gaurav
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.
Diabetes Obes Metab. 2025 Mar;27(3):1388-1396. doi: 10.1111/dom.16139. Epub 2024 Dec 20.
To investigate glycaemic control in Chinese adults with type 2 diabetes (T2D) initiating, or switching to insulin degludec/insulin aspart (IDegAsp), a co-formulation of basal, and bolus insulin, in a real-world setting.
A 20-week, prospective, single-arm, open-label, non-interventional study was conducted in Chinese adults with T2D initiating, or switching to IDegAsp after anti-hyperglycaemic treatment with oral antidiabetic drugs (OADs), other insulins, or glucagon-like peptide-1 receptor agonists. The primary endpoint was a change in HbA from baseline to end of the study; the secondary endpoints included a change in fasting plasma glucose and Diabetes Treatment Satisfaction Questionnaire (DTSQ) score.
Significant reductions were observed in mean HbA and fasting plasma glucose, among both the overall population (N = 878; -1.27%-points [95% CI: -1.36; -1.19]; p < 0.0001, and -1.61 mmol/L [95% CI: -1.81; -1.41]; p < 0.0001, respectively), and in subgroups switching from OADs only, or basal, or premix insulins ± OADs. The mean total DTSQ score increased from 26.4 (baseline) to 31.6 (end-of-study). No significant, or unexpected tolerability, or safety issues were observed. Significant reductions were observed in incidence rates of non-severe (rate ratio 0.37 [95% CI: 0.24; 0.59]; p < 0.0001) and nocturnal non-severe (rate ratio 0.45 [95% CI: 0.21; 0.94]; p = 0.0326) hypoglycaemic episodes.
In a broad, real-world Chinese population of adults with T2D, initiating or switching to IDegAsp was associated with improved glycaemic control and lower rates of hypoglycaemia. The use of IDegAsp could be an effective treatment option for those with suboptimal glycaemic control or therapeutic inertia.
在现实环境中，研究中国2型糖尿病（T2D）成人患者起始或换用德谷胰岛素/门冬胰岛素（IDegAsp，一种基础胰岛素与餐时胰岛素的复方制剂）后的血糖控制情况。
对中国T2D成人患者开展了一项为期20周的前瞻性、单臂、开放标签、非干预性研究，这些患者在用口服降糖药（OADs）、其他胰岛素或胰高血糖素样肽-1受体激动剂进行降糖治疗后起始或换用IDegAsp。主要终点是从基线到研究结束时糖化血红蛋白（HbA）的变化；次要终点包括空腹血糖的变化以及糖尿病治疗满意度问卷（DTSQ）评分。
在总体人群（N = 878；-1.27个百分点[95%置信区间：-1.36；-1.19]；p < 0.0001，以及-1.61 mmol/L[95%置信区间：-1.81；-1.41]；p < 0.0001）以及仅从OADs、基础胰岛素或预混胰岛素±OADs转换过来的亚组中，均观察到HbA和空腹血糖显著降低。DTSQ总评分均值从26.4（基线）升至31.6（研究结束时）。未观察到显著或意外的耐受性或安全性问题。非严重低血糖事件（率比0.37[95%置信区间：0.24；0.59]；p < 0.0001）和夜间非严重低血糖事件（率比0.45[95%置信区间：0.21；0.94]；p = 0.0326）的发生率显著降低。
在广泛的中国T2D成人现实人群中，起始或换用IDegAsp与血糖控制改善及低血糖发生率降低相关。对于血糖控制不佳或治疗惰性患者，使用IDegAsp可能是一种有效的治疗选择。
