NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin, China.
Department of Endocrinology, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China.
BMJ Open. 2023 May 16;13(5):e069080. doi: 10.1136/bmjopen-2022-069080.
Recent cardiovascular outcomes trials have demonstrated that glucagon-like peptide 1 receptor agonist (GLP-1RA) decreases the incidence of major adverse cardiovascular events (MACEs) in individuals with type 2 diabetes mellitus (T2DM). Polyethylene glycol loxenatide (PEG-Loxe) is a once-weekly GLP-1RA obtained by modifying exendin-4. No clinical trials have been designed to assess the impact of PEG-Loxe on cardiovascular (CV) outcomes in individuals with T2DM. This trial aims to test the hypothesis that compared with placebo, PEG-Loxe treatment does not result in an unacceptable increase in CV risk in individuals with T2DM.
This study is a multicentre, randomised, double-blind, placebo-controlled trial. Patients with T2DM who fulfilled the inclusion criteria were randomly divided to receive weekly administration of either PEG-Loxe 0.2 mg or placebo (1:1 ratio). The randomisation was stratified according to utilisation of sodium-glucose cotransporter 2 inhibitors, history of CV disease and body mass index. The research period is expected to be 3 years, with a 1-year recruitment period and a 2-year follow-up period. The primary outcome is the occurrence of the first MACE, described as CV death, non-fatal myocardial infarction or non-fatal stroke. The statistical analyses were undertaken on the intent-to-treat patient. The primary outcome was evaluated using a Cox proportional hazards model with treatment and randomisation strata as the covariates.
The current research has been authorised by the Ethics Committee of Tianjin Medical University Chu Hsien-I Memorial Hospital (approval number: ZXYJNYYhMEC2022-2). Researchers must acquire informed consent from every participant before conducting any protocol-associated procedures. The findings of this study will be published in a peer-reviewed journal.
ChiCTR2200056410.
最近的心血管结局试验表明，胰高血糖素样肽 1 受体激动剂（GLP-1RA）可降低 2 型糖尿病（T2DM）患者主要不良心血管事件（MACEs）的发生率。聚乙二醇洛塞那肽（PEG-Loxe）是一种通过修饰 exendin-4 获得的每周一次的 GLP-1RA。目前尚无临床试验设计用于评估 PEG-Loxe 对 T2DM 患者心血管（CV）结局的影响。本试验旨在检验以下假设，即与安慰剂相比，PEG-Loxe 治疗不会导致 T2DM 患者 CV 风险增加不可接受。
本研究为多中心、随机、双盲、安慰剂对照试验。符合纳入标准的 T2DM 患者被随机分为每周接受 PEG-Loxe 0.2mg 或安慰剂（1:1 比例）治疗。随机分组根据钠-葡萄糖共转运蛋白 2 抑制剂的使用情况、心血管疾病史和体重指数进行分层。预计研究期为 3 年，招募期为 1 年，随访期为 2 年。主要结局是首次发生主要心血管不良事件（MACE），描述为心血管死亡、非致死性心肌梗死或非致死性卒中。统计分析采用意向治疗患者的 Cox 比例风险模型，以治疗和随机分层为协变量。
本研究已获得天津医科大学朱宪彝纪念医院伦理委员会的批准（批准号：ZXYJNYYhMEC2022-2）。在进行任何与方案相关的程序之前，研究人员必须获得每位参与者的知情同意。本研究的结果将发表在同行评议的期刊上。
ChiCTR2200056410。
