Aim: To investigate the effectiveness and safety of teneligliptin over placebo in patients with type 2 diabetes (T2D) inadequately controlled by triple therapy. Materials and Methods: This trial was a prospective, multicentre, randomized, double-blind, placebo-controlled study. The 12-week double-blind period was followed by a 12-week, open-label clinical trial. One hundred patients with T2D who failed to achieve the glycaemic target (7.1% ≤ HbA1c ≤ 9.0%) with conventional triple oral antidiabetic drugs (OADs) of metformin, sulphonylurea, and sodium-glucose co-transporter-2 inhibitor were assigned randomly 1:1 into teneligliptin and placebo-teneligliptin groups. The primary endpoint was mean change in HbA1c level from baseline in each group at 12 weeks. Results: For a total of 99 patients (n = 51 for the teneligliptin group, and n = 48 for the placebo-teneligliptin group), the mean age and duration of diabetes were 60.7 and 13.6 years, respectively, and HbA1c was 7.8% at baseline. At 12 weeks, the teneligliptin group achieved a significant reduction in HbA1c from baseline (−0.9% ± 0.6%, P <.001), with an intergroup difference of −0.75% compared with the placebo group (95% CI [–0.99%, –0.51%], P <.001). At the end of the 24-week treatment period, both groups showed significant reductions in HbA1c level from baseline (placebo-teneligliptin group, –0.8% ± 0.6% [P <.001], teneligliptin group, –0.9% ± 0.6% [P <.001]), without significant intergroup difference (−0.17%, 95% CI [−0.41%, 0.07%], P =.156). There was no significant difference between the groups in the rate of adverse events (placebo-teneligliptin group, n = 3 [6.3%]; teneligliptin group, n = 11 [11.1%]; P =.550), and the safety profiles were favourable in both groups. Conclusions: The current study shows that teneligliptin could be a valid option as a fourth OAD for the treatment of patients with T2D inadequately controlled with a triple combination of OADs.
|Number of pages||9|
|Journal||Diabetes, Obesity and Metabolism|
|Publication status||Published - 2022 Jun|
Bibliographical noteFunding Information:
This study was supported by research grants from Handok Corporation (4‐2020‐0678‐001), the “SENTINEL (Severance ENdocrinology daTa scIeNcE pLatform)” programme funded by the 2020 Research fund of Department of Internal Medicine, Severance Hospital, Seoul, Korea, and a Sung‐Kil Lim Research Award (4‐2018‐1215; DUCD000002) in statistical analyses.
© 2022 John Wiley & Sons Ltd.
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism