Abstract
ABSTRACT
Aims
To evaluate the long‐term efficacy and safety of teneligliptin add‐on in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and empagliflozin.
Materials and Methods
In this randomised, double‐blind, phase 3 trial, 214 patients received teneligliptin 20 mg (
n
= 107) or placebo (
n
= 107) once daily for 24 weeks, in addition to metformin (≥ 1000 mg/day) and empagliflozin (25 mg/day). In a subsequent 28‐week open‐label extension, all patients received teneligliptin 20 mg/day. The primary endpoint was HbA1c change from baseline to week 24.
Results
At week 24, the least squares mean (LSM) change in HbA1c from baseline was −0.70% ± 0.06% in the teneligliptin group and −0.03% ± 0.06% in the placebo group, with a placebo‐adjusted LSM change of −0.67% (95% CI, −0.84 to −0.49;
p
p
β
‐cell function were observed at week 24. During the open‐label extension, glycaemic improvements were maintained through week 52, although no concurrent randomised control was available beyond week 24. Placebo‐group patients achieved a similar benefit after switching to teneligliptin. Safety outcomes did not differ between groups.
Conclusions
Adding teneligliptin to metformin and empagliflozin in patients with inadequately controlled T2DM significantly improved glycaemic control and
β
‐cell function over 24 weeks and was well tolerated through 52 weeks.
Trail Registration
ClinicalTrials.gov
Identifier: NCT05504226.