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 (TERA305 Study)
In brief
Teneligliptin cuts HbA1c by an additional 0.67 points at 24 weeks
In 214 adults with type 2 diabetes still above target on metformin and empagliflozin, adding teneligliptin lowered HbA1c by 0.67 percentage points more than placebo over 24 weeks. Glucose improvements continued through week 52, and safety outcomes were similar, but everyone received teneligliptin during the final 28 weeks, so longer-term benefit lacks a randomized comparison.
- Journal
- Diabetes, obesity & metabolism (Q1)
- Published
- 5 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Jun Sung Moon, Kyung Ah Han, Dong-Lim Kim, Sang Yong Kim, Soo-Kyung Kim, Bon Jeong Ku, et al.
- PMID
- 42832816
- DOI
- 10.1111/dom.71315
Why clinicians should know about it
- Picked for Internal Medicine (top studies of the week, 1 November 2026): Teneligliptin added to metformin+empagliflozin lowered HbA1c by 0.67% at 24
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 < 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 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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.