Comparison of effects of Empagliflozin and Linagliptin on renal function and glycaemic control: a double-blind, randomized clinical trial

BACKGROUND: This study aimed to compare the effects of Linagliptin and Empagliflozin on renal function and glycaemic control in patients with type 2 diabetes mellitus (DM). METHOD: We conducted a randomized, double-blind, parallel trial on patients aged 30 to 80 years with type 2 DM and HbA1c ≤ 9%, regardless of background medical therapy, to compare the effects of Empagliflozin and Linagliptin on albuminuria, FBS, HbA1c, and eGFR. Participants were given the mentioned drugs for 12 weeks. Statistical analysis was performed using appropriate tests in IBM™SPSS® statistics software for windows version 24. RESULTS: In total, 60 patients participated in the study, thirty patients in each group. The mean age of participants was 56.8 (SD = 8.15) in the Empagliflozin group and 60.9 (SD = 7.22) in the Linagliptin group. Before the intervention, FBS, HbA1C, and albuminuria values were significantly higher in the Empagliflozin group than those in the Linagliptin group (P < 0.05), but there was no significant difference between groups regarding eGFR (P = 0.271). Changes in the FBS, HbA1C, and eGFR were not significantly different between groups (P > 0.05), but there was more decrease in albuminuria in the Empagliflozin group compared to the Linagliptin group (P = 0.001, Cohen’s d = 0.98). CONCLUSIONS: Regardless of baseline albuminuria, eGFR, or HbA1c, Empagliflozin 10 mg daily significantly reduced albuminuria at 12 weeks compared to Linagliptin 5 mg daily in patients with type 2 diabetes. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20200722048176N1. Registered 3 August 2020.