在 6 个国家开展的一项真实世界、前瞻性、非干预性研究：在 2 型糖尿病成人中起始或转换用胰岛素德谷胰岛素/门冬胰岛素

Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries.

机构信息

Department of Diabetes, Endocrinology and Metabolism, Royal North Shore Hospital, Sydney, NSW, 2065, Australia.

Northern Clinical School, University of Sydney, Sydney, NSW, Australia.

出版信息

Adv Ther. 2022 Aug;39(8):3735-3748. doi: 10.1007/s12325-022-02212-3. Epub 2022 Jun 25.

DOI:10.1007/s12325-022-02212-3

PMID:35752730

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9244059/

Abstract

INTRODUCTION

Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (a basal insulin) and insulin aspart (a prandial insulin). The aim of this study was to investigate clinical outcomes in people with type 2 diabetes (T2D) after initiating IDegAsp treatment in a real-world setting.

METHODS

This 26-week, open-label, non-interventional study was conducted in Australia, India, Malaysia, Philippines, Saudi Arabia, and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp from antidiabetic treatments (including oral antidiabetic drugs, basal insulin, basal-bolus insulin, premix insulin, and glucagon-like peptide 1 receptor agonist) per local clinical practice.

RESULTS

Compared with baseline, there was significant improvement in HbA1c at end of study (EOS, first visit within weeks 26-36; estimated change - 1.4% [95% CI - 1.51; - 1.29]; P < 0.0001 [primary outcome]). From baseline to EOS, there were significant reductions in fasting plasma glucose (- 2.7 mmol/L [95% CI - 2.98; - 2.46]; P < 0.0001), body weight (- 1.0 kg [95% CI - 1.51; - 0.52]; P < 0.0001), and basal insulin dose in insulin-experienced participants (- 2.3 units [95% CI - 3.51; - 1.01]; P < 0.001). The incidence rates of non-severe (overall and nocturnal) and severe hypoglycaemia decreased significantly (P < 0.001) between the period before baseline and before EOS.

CONCLUSION

In adults with T2D, initiating or switching to IDegAsp from previous antidiabetic treatment was associated with improved glycaemic control, lower basal insulin dose (in insulin-experienced participants), and lower rates of hypoglycaemia.

TRIAL REGISTRATION

Clinical trial registration NCT04042441.

摘要

介绍

德谷胰岛素/门冬胰岛素（IDegAsp）是德谷胰岛素（一种基础胰岛素）和门冬胰岛素（一种餐时胰岛素）的固定比例复方制剂。本研究旨在评估在真实世界环境中，2 型糖尿病（T2D）患者起始或转换用 IDegAsp 治疗后的临床结局。

方法

这是一项 26 周、开放标签、非干预性研究，在澳大利亚、印度、马来西亚、菲律宾、沙特阿拉伯和南非进行。数据来自 1102 例 T2D 成人患者，他们起始或转换用 IDegAsp 治疗，此前的降糖治疗包括口服降糖药、基础胰岛素、基础-餐时胰岛素、预混胰岛素和胰高血糖素样肽-1 受体激动剂。

结果

与基线相比，研究结束时（EOS，第 26-36 周内的首次访视；估计变化-1.4%[95%CI-1.51；-1.29]；P<0.0001[主要结局]）HbA1c 显著改善。从基线到 EOS，空腹血糖显著降低（-2.7mmol/L[95%CI-2.98；-2.46]；P<0.0001），体重减轻（-1.0kg[95%CI-1.51；-0.52]；P<0.0001），并且在胰岛素治疗患者中基础胰岛素剂量减少（-2.3 个单位[95%CI-3.51；-1.01]；P<0.001）。非重度（总体和夜间）和重度低血糖的发生率在基线前和 EOS 前均显著下降（P<0.001）。