Endocrine Abstracts

Background and aims: To evaluate the efficacy and safety of the newly developed dipeptidyl peptidase-4 (DPP-4) inhibitor evogliptin in drug-naïve patients with inadequately controlled type 2 diabetes.

Materials and methods: In randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase III study, 160 patients with type 2 diabetes were randomized to evogliptin 5 mg or placebo for 24 weeks. The primary efficacy outcome measure was mean changes from baseline to endpoint in hemoglobin A1c (HbA1c).

Results: The mean baseline HbA1c levels of the evoglipitin group and the placebo group were 7.2±0.56% and 7.2±0.63%, respectively (P>0.05). Although the baseline HbA1c was very lower when compared with other phase III clinical trials using DPP-4 inhibitors, evogliptin provided significant placebo-corrected reductions in HbA1c from baseline of −0.23% (P<0.0001) at 24 weeks. Also, the response rate achieving HbA1c <6.5% was significantly higher in the evoglipitin group than placebo group (P=0.008). Overall, incidences of adverse event and hypoglycemia were similar between the two groups.

Conclusion: In this 24-weeks study, once-daily evoglipitin monotherapy significantly improved glycemic control and was well tolerated in patients with type 2 diabetes.