Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Department of Internal Medicine B, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel.
Front Endocrinol (Lausanne). 2021 Dec 22;12:794382. doi: 10.3389/fendo.2021.794382. eCollection 2021.
To assess the effect of linagliptin vs. standard therapy in improving clinical outcomes in patients hospitalized with diabetes and coronavirus disease 2019 (COVID-19).
We did an open-label, prospective, multicenter, randomized clinical trial in 3 Israeli hospitals between October 1, 2020, and April 4, 2021. Eligible patients were adults with type 2 diabetes mellitus and a diagnosis of COVID-19. A total of 64 patients, 32 in each group, were randomized to receive linagliptin 5 mg PO daily throughout the hospitalization or standard of care therapy. The primary outcome was time to clinical improvement within 28 days after randomization, defined as a 2-point reduction on an ordinal scale ranging from 0 (discharged without disease) to 8 (death).
The mean age was 67 ± 14 years, and most patients were male (59.4%). Median time to clinical improvement was 7 days (interquartile range (IQR) 3.5-15) in the linagliptin group compared with 8 days (IQR 3.5-28) in the standard of care group (hazard ratio, 1.22; 95% CI, 0.70-2.15; p = 0.49). In-hospital mortality was 5 (15.6%) and 8 (25.0%) in the linagliptin and standard of care groups, respectively (odds ratio, 0.56; 95% CI, 0.16-1.93). The trial was prematurely terminated due to the control of the COVID-19 outbreak in Israel.
In this randomized clinical trial of hospitalized adult patients with diabetes and COVID-19 who received linagliptin, there was no difference in the time to clinical improvement compared with the standard of care.
ClinicalTrials.gov, identifier NCT04371978.
评估利拉利汀相较于标准疗法在改善因感染 2019 年冠状病毒病（COVID-19）住院的糖尿病患者临床结局方面的效果。
我们在 2020 年 10 月 1 日至 2021 年 4 月 4 日期间在以色列的 3 家医院进行了一项开放标签、前瞻性、多中心、随机临床试验。符合条件的患者为患有 2 型糖尿病且确诊 COVID-19 的成年人。共有 64 名患者（每组 32 名）被随机分配接受利拉利汀 5 毫克 PO 每日治疗或标准护理治疗。主要结局为随机分组后 28 天内临床改善的时间，定义为从 0（无疾病出院）到 8（死亡）的等级量表上的 2 分降低。
平均年龄为 67 ± 14 岁，大多数患者为男性（59.4%）。利拉利汀组的中位临床改善时间为 7 天（四分位距（IQR）3.5-15），而标准护理组为 8 天（IQR 3.5-28）（风险比，1.22；95%置信区间，0.70-2.15；p = 0.49）。利拉利汀组和标准护理组的住院死亡率分别为 5（15.6%）和 8（25.0%）（比值比，0.56；95%置信区间，0.16-1.93）。由于以色列 COVID-19 疫情得到控制，该试验提前终止。
在这项针对接受利拉利汀治疗的因 COVID-19 住院的成年糖尿病患者的随机临床试验中，与标准护理相比，临床改善时间没有差异。
ClinicalTrials.gov，标识符 NCT04371978。
