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)
15 affiliations
- 1Division of Endocrinology and Metabolism, Department of Internal Medicine Yeungnam University College of Medicine Daegu Korea
- 2Division of Endocrinology and Metabolism, Department of Internal Medicine Nowon Eulji Medical Center, Eulji University School of Medicine Seoul Korea
- 3Division of Endocrinology and Metabolism, Department of Internal Medicine Konkuk University School of Medicine Seoul Korea
- 4Division of Endocrinology and Metabolism, Department of Internal Medicine Chosun University School of Medicine Gwangju Korea
- 5Department of Internal Medicine CHA Bundang Medical Center, CHA University School of Medicine Seongnam Korea
- 6Department of Internal Medicine Chungnam National University School of Medicine Daejeon Korea
- 7Department of Internal Medicine Asan Medical Center, University of Ulsan College of Medicine Seoul Korea
- 8Department of Internal Medicine Chungbuk National University Hospital Cheongju Korea
- 9Division of Endocrinology and Metabolism, Department of Internal Medicine Korea University Ansan Hospital, Korea University College of Medicine Ansan Korea
- 10Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine The Catholic University of Korea Seoul Korea
- 11Division of Endocrinology and Metabolism, Department of Internal Medicine Uijeongbu Eulji Medical Center, Eulji University Uijeongbu Korea
- 12Division of Endocrinology and Metabolism, Department of Internal Medicine Kyung Hee University Hospital at Gangdong, and Kyung Hee University School of Medicine Seoul Korea
- 13Division of Endocrinology, Department of Internal Medicine Yongin Severance Hospital, Yonsei University College of Medicine Yongin South Korea
- 14Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, College of Medicine Inje University Busan Korea
- 15Division of Endocrinology and Metabolism, Department of Internal Medicine Yonsei University College of Medicine, 50‐1 Yonsei‐Ro, Seodaemun‐Gu Seoul Korea
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.
Related
- Can metformin prolong pregnancy in preterm pre-eclampsia? Study protocol for a Nordic multicentre randomised placebo-controlled trial (PI4)
- Efficacy and Safety of a Novel Oil Pulling Oral Rinse for Teeth Whitening: A Double-Blind, Randomised, Placebo-Controlled Trial
- Investigating the Efficacy of the Proactive Automatised Lifestyle intervention among general hospital patients (ePAL): study protocol of a randomised controlled trial.
- Comparative efficacy of extracorporeal shockwave therapy versus low-level laser therapy for myogenous temporomandibular disorders: a randomised controlled trial protocol
- Multicentre randomised controlled trial to evaluate the efficacy of DIALIVE 2.0, a liver dialysis device, for the treatment of acute-on-chronic liver failure: study protocol
BibTeX
@article{moon202652week,
title = {{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)}},
author = {Jun Sung Moon and Kyung Ah Han and Dong‐Lim Kim and Sang Yong Kim and Soo‐Kyung Kim and Bon Jeong Ku and Woo Je Lee and Tae Keun Oh and Ji A Seo and Sang‐Ah Chang and Moon‐Kyu Lee and Kyu Jeung Ahn and Chul Sik Kim and Tae Nyun Kim and Bong‐Soo Cha},
journal = {Diabetes, Obesity \& Metabolism},
year = {2026},
month = oct,
doi = {10.1111/dom.71315},
url = {https://doi.org/10.1111/dom.71315},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - 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)
AU - Jun Sung Moon
AU - Kyung Ah Han
AU - Dong‐Lim Kim
AU - Sang Yong Kim
AU - Soo‐Kyung Kim
AU - Bon Jeong Ku
AU - Woo Je Lee
AU - Tae Keun Oh
AU - Ji A Seo
AU - Sang‐Ah Chang
AU - Moon‐Kyu Lee
AU - Kyu Jeung Ahn
AU - Chul Sik Kim
AU - Tae Nyun Kim
AU - Bong‐Soo Cha
PY - 2026
DA - 2026/10/05
JO - Diabetes, Obesity & Metabolism
DO - 10.1111/dom.71315
UR - https://doi.org/10.1111/dom.71315
AB - 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.
SN - 1462-8902
SN - 1463-1326
ER -