Linagliptin (Trajenta) did not reduce time to clinical improvement in patients with type 2 diabetes (T2D) who were hospitalized with COVID-19. These findings, from an open-label, prospective, multicenter randomized trial, were published in Frontiers in Endocrinology.
Between October 2020 and April 2021, patients (N=64) with T2D and COVID-19 infection were recruited for this study from 3 hospitals in Israel. Patients were stratified in a 1:1 ratio to receive 5 mg daily of linagliptin plus standard of care (n=32) or standard of care alone (n=32). The primary outcome was clinical improvement within 28 days of randomization, as defined by a 2-point reduction in the patient’s hospital admission status on a 9-point ordinal scale.
Patients were aged mean 66.95±13.93 years, 59.4% were men, median BMI was 29.1 (interquartile range [IQR], 26.6-33.3) kg/m2, 64.06% were receiving oxygen support on admission, diabetes duration was 13.5 (IQR, 8-19) years, and glycated hemoglobin (HbA1C) was 7.5% (IQR, 6.7%-8.8%). The intervention and control cohorts were well balanced with the exception that patients randomized to receive linagliptin had significantly lower HbA1C at admission (median, 7.4% vs 8.2%; P =.02).
Clinical improvement by day 28 was achieved by 81.3% in the linagliptin group and 71.9% of the standard of care only recipients (odds ratio [OR], 0.59; 95% CI, 0.18-1.91). The median time to improvement was similar between groups (median, 7 vs 8 days; hazard ratio [HR], 1.22; 95% CI, 0.70-2.15; P =.49).
A total of 7 patients in the linagliptin group and 4 patients in the control group were admitted to the intensive care unit (ICU) (OR:1.96, 95% CI, 0.51-7.50). All-cause mortality at 28 days was 7 (21.9%) and 9 (28.1%) in the linagliptin and standard of care groups, respectively. The median length of hospitalization was 7 days in both groups (mean difference, 0.44; 95% CI, -2.83 to 3.71).
Each cohort had 1 hypoglycemia event. One patient who received linagliptin remained hospitalized in the ICU at day 28.
This study was limited by the low sample size; however, the study was terminated when the COVID-19 outbreak ended in Israel during the study.
“The administration of linagliptin in patients with COVID-19 and diabetes did not improve the time to clinical improvement or 28-day mortality,” the study researchers concluded.
Abuhasira R, Ayalon-Dangur I, Zaslavsky N, et al. A randomized clinical trial of linagliptin vs standard of care in patients hospitalized with diabetes and COVID-19. Front Endocrinol. 2021;12:794382. doi:10.3389/fendo.2021.794382