Introduction: Teneligliptin, an antidiabetic agent classified as a class III dipeptidyl peptidase-4 (DPP-4) inhibitor, has a unique structural feature that provides strong binding to DPP-4 enzymes. We investigated the efficacy and safety of switching patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control on a stable dose of other DPP-4 inhibitors to teneligliptin. Methods: Patients with T2DM whose glycosylated hemoglobin (HbA1c) levels were ≥ 7% despite taking DPP-4 inhibitors other than teneligliptin, with or without other hypoglycemic agents, for at least 3 months were enrolled. The DPP-4 inhibitors taken before participating in the study were switched to 20 mg qd teneligliptin, and this was to be maintained for 52 weeks. The primary end point was the change in HbA1c levels after 12 weeks. Metabolic parameters including fasting plasma glucose (FPG) and blood lipids were assessed also. To assess safety, adverse and hypoglycemic events were monitored. The data from baseline to week 12 were used for analysis in this interim report. Results: The mean change in HbA1c levels from baseline to week 12 was − 0.44%. At week 12, the percentage of patients achieving HbA1c < 7.0% was 31.6% and that of achieving HbA1c < 6.5% was 11.4%, respectively. In 41.2% of patients, the HbA1c levels decreased by at least 0.5% at 12 weeks. The mean change in FPG levels from baseline to week 12 was − 11.5 mg/dl. No severe hypoglycemia was reported. Conclusion: After switching to teneligliptin, HbA1c levels decreased significantly in patients with T2DM inadequately controlled with other DPP-4 inhibitors. Trial Registration: ClinicalTrials.gov, NCT03793023. Funding: Handok Inc.
|Number of pages||12|
|Publication status||Published - 2019 Aug 1|
Bibliographical noteFunding Information:
Sponsorship for this study and article processing charges were funded by the Handok Inc., Seoul, Republic of Korea. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
The authors thank the investigators and the participants of the study. Sponsorship for this study and article processing charges were funded by the Handok Inc., Seoul, Republic of Korea. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. HJ.K. and K.W.L. contributed to the design and conduct of the study and the acquisition, analysis, and interpretation of data, and drafted the manuscript. Y.S.K., C.B.L., M-G.C., H-J.C., S.K.K., J.M.Y., T.H.K., J.H.L., and K.J.A. contributed to the conduct of the study and the interpretation of data. K.K. contributed to the design of the study and analysis of data. All authors reviewed and approved the final manuscript. Kyoungmin Kim is an employee of Handok Inc. Hae Jin Kim, Young Sik Kim, Chang Beom Lee, Moon-Gi Choi, Hyuk-Jae Chang, Soo Kyoung Kim, Jae Myung Yu, Tae Ho Kim, Ji Hyun Lee, Kyu Jeung Ahn and Kwan Woo Lee have nothing to disclose. This study was conducted in accordance with the Declaration of Helsinki. All patients gave written informed consent before participating in the study, and the study was initiated after approval of the study protocol by the institutional review board at each site or by the local institutional review boards (Supplementary Table?S2), including Ajou University Hospital IRB (AJIRB-MED-OBS-15-410). The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
© 2019, The Author(s).
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism