Abstract

To assess the effectiveness and safety of evogliptin versus linagliptin in type 2 diabetic patients. Method: 200 individuals with type 2 diabetes with HbA1c levels between 7.1% and 10.1% were divided equally into two groups and given daily doses of either linagliptin 5 mg or evogliptin 5 mg for a period of 12 weeks. The change from baseline HbA1c at week 11 served as the primary efficacy outcome. The change in the mean amplitude of glycaemic excursion (MAGE), as determined by continuous glucose monitoring, served as the secondary endpoint. Evogliptin 5 mg daily was given to both groups in the extension study during the course of the subsequent 11 weeks: the evogliptin/evogliptin group (n = 100) and the linagliptin/evogliptin group (n = 100). Results: The mean change in HbA1c in the linagliptin and evogliptin groups after 11 weeks of treatment was 0.84 and 0.74 percent, respectively. Based on a non-inferiority margin of 0.3%, the between-group difference was 0.11% (95% CI: -0.31 to 0.10), indicating noninferiority. In the evogliptin group, the change in MAGE was 24.5 mg/dL, whereas in the linagliptin group, it was 16.6 mg/dL. These numbers were significantly below the starting points in both groups' data. However, there was little difference between the two groups. At week 25, HbA1c decreased by 0.93% in the evogliptin/evogliptin group, with HbA1c values of 7.1% in 80.1% of the patients. For 25 weeks, there was no significant difference in the frequency or kind of adverse events between the two groups. Conclusion: Evogliptin's ability to reduce blood sugar in this study was non-inferior to linagliptin's. A 0.93% decrease in HbA1c at week 25 allowed for its maintenance. In patients with type 2 diabetes, evogliptin medication increased glycaemic variability without resulting in any severe side effects.

Description