A 52-Week Efficacy and Safety Study of Teneligliptin, as an Add-On to Empagliflozin and Metformin in Patients With Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial (TERA305Study)

초록

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 < 0.0001), demonstrating the superiority of teneligliptin. A significant between-group difference was already evident at week 4 (placebo-adjusted LSM change, -0.36%; p < 0.0001). Significant reductions in fasting plasma glucose and glycated albumin and improvement in pancreatic beta-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 beta-cell function over 24 weeks and was well tolerated through 52 weeks. Trail Registration: ClinicalTrials.gov Identifier: NCT05504226.

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