A Randomized Clinical Trial of Linagliptin vs. Standard of Care in Patients Hospitalized With Diabetes and COVID-19

Frontiers in Endocrinology

Mally Keller¹  Ronit Koren¹  Alon Grossman²  Ran Abuhasira²  Neta Zaslavsky²  Dror Dicker³  Irit Ayalon-Dangur⁴ 

[1] Department of Internal Medicine A, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel;Department of Internal Medicine B, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel;Department of Internal Medicine D, Rabin Medical Center, Hasharon Campus, Petah Tikva, Israel;Department of Internal Medicine E, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel;Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel;

关键词: COVID-19;    diabetes;    linagliptin;    DPP-4 inhibitors;    hospital management;   

DOI  :  10.3389/fendo.2021.794382

来源: DOAJ

【 摘 要 】

ObjectiveTo assess the effect of linagliptin vs. standard therapy in improving clinical outcomes in patients hospitalized with diabetes and coronavirus disease 2019 (COVID-19).Materials and MethodsWe 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).ResultsThe 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.ConclusionsIn 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.Clinical Trial RegistrationClinicalTrials.gov, identifier NCT04371978.

【 授权许可】

Unknown