Guo Lixin, Li Li, Yu Qiurong, Wang Na, Chen Jun, Wang Zhiquan, Ding Yuchen
Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Science, Beijing, China.
Department of Endocrinology, Ningbo First Hospital, Zhejiang, China.
Diabetes Ther. 2022 Jun;13(6):1231-1244. doi: 10.1007/s13300-022-01268-2. Epub 2022 May 18.
TRUST-CHN is a prospective, post-marketing safety study in patients with type 2 diabetes mellitus (T2DM) in China to evaluate the safety and effectiveness of dulaglutide in real-world clinical practice. We report here the study design and baseline characteristics of enrolled patients.
The study design was described, and baseline data were analyzed, including demographic characteristics, T2DM duration, comorbidities, dulaglutide treatment patterns, and concomitant medications.
For the present analysis of this ongoing study, data were collected from January 2020 to November 2021. A total of 3313 patients were enrolled, of whom 3294 patients were included in the safety analysis. In total, 1047 patients had a prior history of dulaglutide use before being enrolled in the study. The mean (standard deviation [SD]) age of study subjects was 50.1 (13.2) years, 85.1% were aged < 65 years; 67.9% were male, and 35.9% had an education of university level or higher. Mean (SD) duration of T2DM was 6.4 (6.7) years. Baseline mean (SD) glycated hemoglobin was 8.8% (2.2%), and mean (SD) body mass index was 28.1 (4.1) kg/m. A total of 2867 (87%) patients had at least one comorbidity, the most frequently reported of which were overweight/obesity (87.1%), hyperlipidemia (50.5%), hypertension (47.9%), diabetic neuropathy (18.9%), and coronary artery disease (15.7%). Almost all (99.7%) patients were treated with 1.5 mg dulaglutide; at baseline, 24.8% were treated with this medication as monotherapy and 75.2% in combination therapy with other medications, including metformin (42.3%), sodium glucose co-transporter2 inhibitor (26.7%), insulin (18.3%), α-glucosidase inhibitor (13.1%), sulfonylurea (5.3%), dipeptidyl peptidase 4 inhibitor (4.4%), glucagon-like peptide 1 receptor agonist (2.7%), and thiazolidinedione (2.4%).
The present analysis revealed real-world baseline characteristics of patients with T2DM in China who use dulaglutide enrolled in TRUST-CHN. These data will enable further exploration of the characteristics of patients with T2DM in China and provide an insight on the current use of dulaglutide in clinical practice.
TRUST-CHN是一项在中国2型糖尿病（T2DM）患者中进行的前瞻性上市后安全性研究，旨在评估度拉糖肽在真实世界临床实践中的安全性和有效性。我们在此报告入组患者的研究设计和基线特征。
描述了研究设计，并分析了基线数据，包括人口统计学特征、T2DM病程、合并症、度拉糖肽治疗模式和伴随用药情况。
对于这项正在进行的研究的当前分析，数据收集时间为2020年1月至2021年11月。共入组3313例患者，其中3294例患者纳入安全性分析。共有1047例患者在入组本研究之前有使用过度拉糖肽的病史。研究对象的平均（标准差[SD]）年龄为50.1（13.2）岁，85.1%的患者年龄＜65岁；67.9%为男性，35.9%具有大学及以上学历。T2DM的平均（SD）病程为6.4（6.7）年。基线糖化血红蛋白平均（SD）为8.8%（2.2%），平均（SD）体重指数为28.
