Efficacy and safety of evogliptin treatment in patients with type 2 diabetes: A multicentre, active‐controlled, randomized, double‐blind study with open‐label extension (the EVERGREEN study)

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2020-09, Vol.22 (9), p.1527-1536
• Main Authors: Kim, Gyuri, Lim, Soo, Kwon, Hyuk‐Sang, Park, Ie B., Ahn, Kyu J., Park, Cheol‐Young, Kwon, Su K., Kim, Hye S., Park, Seok W., Kim, Sin G., Moon, Min K., Kim, Eun S., Chung, Choon H., Park, Kang S., Kim, Mikyung, Chung, Dong J., Lee, Chang B., Kim, Tae H., Lee, Moon‐Kyu
• Format: Article
• Language: English
• Subjects: Clinical outcomes; Clinical trials; continuous glucose monitoringdipeptidyl peptidase‐4 inhibitorevogliptinglycaemic variabilitylinagliptintype 2 diabetes; Diabetes; Diabetes mellitus (non-insulin dependent); Double-blind studies; Effectiveness; Glucose monitoring; Inhibitor drugs; Original; Patient safety
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.14061

Aim To investigate the efficacy and safety of evogliptin compared with linagliptin in patients with type 2 diabetes. Materials and Methods In this 12‐week, multicentre, randomized, double‐blind, active‐controlled, and 12‐week open‐label extension study, a total of 207 patients with type 2 diabetes who had HbA1c levels of 7.0%‐10.0% were randomized 1:1 to receive evogliptin 5 mg (n = 102) or linagliptin 5 mg (n = 105) daily for 12 weeks. The primary efficacy endpoint was the change from baseline HbA1c at week 12. The secondary endpoint was the change in the mean amplitude of glycaemic excursion (MAGE) assessed by continuous glucose monitoring. In the extension study conducted during the following 12 weeks, evogliptin 5 mg daily was administered to both groups: evogliptin/evogliptin group (n = 95) and linagliptin/evogliptin group (n = 92). Results After 12 weeks of treatment, the mean change in HbA1c in the evogliptin group and in the linagliptin group was −0.85% and −0.75%, respectively. The between‐group difference was −0.10% (95% CI: −0.32 to 0.11), showing non‐inferiority based on a non‐inferiority margin of 0.4%. The change in MAGE was −24.6 mg/dL in the evogliptin group and −16.7 mg/dL in the linagliptin group. These values were significantly lower than the baseline values in both groups. However, they did not differ significantly between the two groups. In the evogliptin/evogliptin group at week 24, HbA1c decreased by −0.94%, with HbA1c values of