Teneligliptin Add-On Therapy Improves Glycemic Control in Type 2 Diabetes: Study
South Korea: A Phase 3 trial in South Korea, published in Diabetes, Obesity and Metabolism, has found that adding teneligliptin to metformin and empagliflozin significantly improved glycaemic control in patients with inadequately controlled type 2 diabetes. At 24 weeks, teneligliptin achieved a 0.67 percentage-point greater reduction in HbA1c compared with placebo. The benefit persisted through 52 weeks, with no new safety concerns reported.
Many individuals with type 2 diabetes fail to achieve recommended HbA1c targets despite receiving metformin and an SGLT2 inhibitor such as empagliflozin. Additional treatment options are therefore needed that can lower blood glucose effectively while remaining safe and easy to use. Teneligliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances incretin activity and promotes glucose-dependent insulin secretion.
The TERA305 trial, conducted by Jun Sung Moon at Yeungnam University College of Medicine and colleagues, assessed whether adding teneligliptin to existing metformin–empagliflozin therapy could improve glycaemic control in patients who had not reached their treatment goals
In the randomised, double-blind, placebo-controlled Phase 3 study, 214 adults with inadequately controlled type 2 diabetes were allocated in equal numbers to teneligliptin 20 mg once daily or matching placebo for 24 weeks. Participants continued metformin at a minimum dose of 1,000 mg daily and empagliflozin 25 mg daily throughout the trial. The primary outcome was the change in HbA1c from baseline to week 24. After the double-blind period, all participants entered a 28-week open-label extension and received teneligliptin, allowing assessment of treatment durability and safety through week 52.
Key findings:
- At week 24, HbA1c decreased by 0.70 percentage points with teneligliptin, compared with 0.03 percentage points with placebo.
- The placebo-adjusted HbA1c reduction with teneligliptin was 0.67 percentage points, a statistically significant difference.
- A meaningful separation between teneligliptin and placebo was observed as early as week 4.
- Teneligliptin also significantly lowered fasting plasma glucose and glycated albumin at week 24.
- Improvements in pancreatic beta-cell function were seen with teneligliptin treatment.
- During the open-label extension, participants who switched from placebo to teneligliptin achieved a similar improvement in glycaemic control.
- Patients who received teneligliptin throughout the study maintained their glycaemic benefit through week 52
- Safety outcomes were comparable between teneligliptin and placebo during the controlled phase, and no new safety concerns emerged during longer-term follow-up.
The study had several limitations. The placebo-controlled comparison lasted only 24 weeks, limiting conclusions about long-term comparative efficacy. Teneligliptin was not compared with other DPP-4 inhibitors or alternative treatment strategies. The exclusively Korean population may limit generalisability, and cardiovascular outcomes, continuous glucose monitoring metrics, and patient-reported outcomes were not assessed.
Overall, the TERA305 findings support teneligliptin 20 mg once daily as an effective, well-tolerated add-on therapy for patients with type 2 diabetes inadequately controlled with metformin and empagliflozin. It improved HbA1c, fasting plasma glucose, and beta-cell function over 24 weeks, with benefits maintained and a favourable safety profile observed through 52 weeks.
Reference:
J. S. Moon, K. A. Han, D.-L. Kim, et al., “ 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),” Diabetes, Obesity and Metabolism (2026): 1–11, https://doi.org/10.1111/dom.71315.
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