背景:TRUST-CHN是一个前瞻性的,在中国的2型糖尿病(T2DM)患者中进行上市后安全性研究,以评估杜拉鲁肽在实际临床实践中的安全性和有效性。我们在此报告入选患者的研究设计和基线特征。
方法:描述了研究设计,并对基线数据进行了分析,包括人口特征,T2DM持续时间,合并症,杜拉鲁肽治疗模式,和伴随的药物。
结果: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。共纳入3313例患者,其中3294例患者被纳入安全性分析.总的来说,1047名患者在被纳入研究之前有杜拉鲁肽使用史。研究对象的平均年龄(标准差[SD])为50.1(13.2)岁,年龄<65岁的占85.1%;男性占67.9%,35.9%的人受过大学或更高学历。T2DM的平均(SD)持续时间为6.4(6.7)年。基线平均(SD)糖化血红蛋白为8.8%(2.2%),平均(SD)体重指数为28.1(4.1)kg/m2。共有2867名(87%)患者至少有一种合并症,其中最常报告的是超重/肥胖(87.1%),高脂血症(50.5%),高血压(47.9%),糖尿病性神经病变(18.9%),和冠状动脉疾病(15.7%)。几乎所有(99.7%)患者均接受1.5mg杜拉鲁肽治疗;在基线时,24.8%采用这种药物作为单一疗法,75.2%与其他药物联合治疗,包括二甲双胍(42.3%),钠葡萄糖共转运2抑制剂(26.7%),胰岛素(18.3%),α-葡萄糖苷酶抑制剂(13.1%),磺酰脲(5.3%),二肽基肽酶4抑制剂(4.4%),胰高血糖素样肽1受体激动剂(2.7%),和噻唑烷二酮(2.4%)。
结论:本分析揭示了TRUST-CHN中使用杜拉鲁肽的中国T2DM患者的真实世界基线特征。这些数据将有助于进一步探索中国2型糖尿病患者的特点,并为当前杜拉鲁肽在临床实践中的使用提供见解。
BACKGROUND: 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.
METHODS: The study design was described, and baseline data were analyzed, including demographic characteristics, T2DM duration, comorbidities, dulaglutide treatment patterns, and concomitant medications.
RESULTS: 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/m2. 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%).
CONCLUSIONS: 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.