Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.

ABSTRACT: AIMS:This trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone. METHODS:Adult patients with type 2 diabetes mellitus (N?=?222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (?1000?mg/d) were randomized 1:1 to add-on evogliptin 5?mg (N?=?112) or sitagliptin 100?mg (N?=?110) once daily for 24?weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was <0.35%. RESULTS:Mean changes in HbA1c following addition of evogliptin or sitagliptin were -0.59% and -0.65%, respectively. The between-group difference was 0.06% (2-sided 95% confidence interval, -0.10 to 0.22), demonstrating non-inferiority. After the 52-week treatment, evogliptin caused a persistently decreased level of HbA1c (-0.44%?±?0.65%, P ?

SUBMITTER: Hong SM 

PROVIDER: S-EPMC5412933 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature