聚乙二醇洛塞那肽联合基础胰岛素治疗2型糖尿病患者的疗效：一项回顾性真实世界研究
Efficacy of Polyethylene Glycol Loxenatide in Combination with Basal Insulin in Patients with Type 2 Diabetes Mellitus: A Retrospective Real-World Study.
作者信息
Liu Xiaohuan, Zhang Ying, Zhao Li-Ling, Duan Yale, Hu Zhizhen, Bao Liya, Jin Ping
机构信息
Department of Endocrinology, The Third Xiangya Hospital, Central South University, Changsha, 410007, Hunan, China.
Department of Medical Affairs, Jiangsu Hansoh Pharmaceutical Group Co., Ltd., Shanghai, 201210, China.
出版信息
Diabetes Ther. 2025 Apr 11. doi: 10.1007/s13300-025-01737-4.
INTRODUCTION
Patients with type 2 diabetes mellitus (T2DM) who cannot achieve normal glycosylated hemoglobin (HbA1c) levels are sometimes given the combined therapeutic regimen of polyethylene glycol loxenatide (PEG-Loxe) + basal insulin. The aim of this study was to investigate the efficacy and safety of PEG-Loxe combined with basal insulin in patients with T2DM.
METHODS
This retrospective, real-world study included patients with T2DM aged ≥ 18 years for whom basal insulin therapy was ineffective, whose HbA1c levels were between 7.0% and 11.0%, and who were on either continued basal insulin dose adjustment or who had received PEG-Loxe + basal insulin combined therapy for at least 24 weeks. The primary endpoint was change in HbA1c level after 24 weeks treatment. Secondary endpoints included HbA1c achievement target rate, change in fasting plasma glucose and body weight, respectively, and change in HbA1c stratified by sex, age, disease duration, and baseline HbA1c level.
RESULTS
Overall, 307 patients were identified. After propensity score matching, 44 patients each were included in the basal insulin and PEG-Loxe + basal insulin group. After 24 weeks, a significant difference in Hb1Ac reduction between the groups (P = 0.003) was observed. Also, patients treated with PEG-Loxe + basal insulin combined therapy experienced greater body weight reduction compared those treated with basal insulin only (intergroup difference: - 3.2 kg; 95% confidence interval [95% CI] - 5.4, - 1.0]; P = 0.005). There was a significant intergroup difference in weight reduction in patients with body mass index ≥ 28 kg/m (- 8.4 kg; 95% CI - 13.9, - 3.0; P = 0.004). HbA1c levels in female patients aged < 65 years with HbA1c ≥ 8.5% and with a disease duration ≥ 10 years were significantly different between the two treatment groups (P < 0.005). Hypoglycemic events occurred in 10.4% of patients treated with PEG-Loxe + basal insulin with no cases of level 3 hypoglycemia.
CONCLUSION
PEG-Loxe + basal insulin combined therapy was safe and effective in patients with T2DM who did not achieve optimal glycemic control with insulin therapy alone.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: ChiCTR2400086699.
引言
无法使糖化血红蛋白（HbA1c）水平达到正常的2型糖尿病（T2DM）患者有时会接受聚乙二醇洛塞那肽（PEG-Loxe）+基础胰岛素的联合治疗方案。本研究旨在探讨PEG-Loxe联合基础胰岛素治疗T2DM患者的疗效和安全性。
方法
这项回顾性的真实世界研究纳入了年龄≥18岁、基础胰岛素治疗无效、HbA1c水平在7.0%至11.0%之间、正在持续调整基础胰岛素剂量或已接受PEG-Loxe+基础胰岛素联合治疗至少24周的T2DM患者。主要终点是治疗24周后HbA1c水平的变化。次要终点分别包括HbA1c达标率、空腹血糖和体重的变化，以及按性别、年龄、病程和基线HbA1c水平分层的HbA1c变化。
结果
总体上，共纳入307例患者。经过倾向得分匹配后，基础胰岛素组和PEG-Loxe+基础胰岛素组各纳入44例患者。24周后，观察到两组之间Hb1Ac降低存在显著差异（P = 0.003）。此外，与仅接受基础胰岛素治疗的患者相比，接受PEG-Loxe+基础胰岛素联合治疗的患者体重减轻更多（组间差异：-3.2 kg；95%置信区间[95%CI] -5.4，-1.0]；P = 0.005）。体重指数≥28 kg/m的患者体重减轻存在显著组间差异（-8.4 kg；95%CI -13.9，-3.0；P = 0.004）。在HbA1c≥8.5%且病程≥10年的<65岁女性患者中，两种治疗组的HbA1c水平存在显著差异（P < 0.005）。接受PEG-Loxe+基础胰岛素治疗的患者中10.4%发生低血糖事件，无3级低血糖病例。
结论
对于仅接受胰岛素治疗未实现最佳血糖控制的T2DM患者，PEG-Loxe+基础胰岛素联合治疗安全有效。
试验注册
ClinicalTrials.gov标识符：ChiCTR2400086699。
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