Introduction: The aim of this study was to assess the efficacy and safety of switching to teneligliptin from other dipeptidyl peptidase-4 (DPP-4) inhibitors in patients with type 2 diabetes mellitus (T2DM) inadequately controlled despite treatment with a stable dose of other DPP-4 inhibitors. Methods: Patients with glycosylated hemoglobin (HbA1c) ≥ 7% despite taking DPP-4 inhibitors other than teneligliptin, with or without other antidiabetic agents, for at least 3 months were enrolled in this study. Patients on DPP-4 inhibitors administered prior to participation in this study were switched to 20 mg teneligliptin once daily and the dose was maintained for the 52-week study period. The primary endpoint was the change in HbA1c at week 12. Fasting plasma glucose (FPG) and the blood lipid profile were also evaluated. Adverse events were monitored for safety assessment. Results: At weeks 12, 24, and 52, the HbA1c values significantly decreased by − 0.39, − 0.44, and − 0.52%, respectively, compared to the baseline value (p < 0.0001); in addition, 56.3, 60.3, and 62.3% of patients, respectively, achieved decreases in HbA1c of at least 0.3%, and 40.1, 46.5, and 52.4% of patients, respectively, achieved decreases in HbA1c of at least 0.5%. The proportion of the patient population achieving HbA1c < 7.0% increased throughout the study period, reaching 30.4, 35.4, and 36.9% at weeks 12, 24, and 52, respectively; at these same time points, the percentage of patients achieving HbA1c < 6.5% increased to 9.5, 11.9, and 13.2% of the total study population. FPG levels and lipid parameters were also significantly decreased after teneligliptin treatment. There were no significant safety concerns. Conclusion: Our results suggest the significant glucose-lowering effect of teneligliptin after switching from other DPP-4 inhibitors in patients with T2DM. The improvement in glycemic control was maintained for up to 52 weeks without safety concerns.
Bibliographical noteFunding Information:
Sponsorship for this study and the Rapid Service Fee were funded by 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 the Rapid Service Fee were funded by 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 of this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. HJK and KWL contributed to the design and conduct of the study and the acquisition, analysis, and interpretation of data, and drafted the manuscript. YSK, CBL, M-GC, H-JC, SKK, JMY, THK, JHL, KJA, and KWM contributed to the conduct of the study and the interpretation of data. EJK and YKK contributed to the design of the study and analysis of data. All authors reviewed and approved the final manuscript. Eun Jung Kyung and Yeo Kyeong Kim are employees 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, Kyung Wan Min and Kwan Woo Lee have nothing to disclose. All patients provided written informed consent before being enrolled in the study. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the institutional review board of each center or by the local institutional review board (IRB), including Ajou University Hospital IRB (AJIRB-MED-OBS-15-410) (a full list of participating centers is provided in ESM Table S2). The datasets generated and/or analyzed during this study are available from the corresponding author on reasonable request.
© 2021, The Author(s).
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism