Back to Journals » Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy » Volume 12

QT/QTc safety and efficacy evaluation of teneligliptin in Indian type 2 diabetes mellitus patients: the “thorough QT/QTc” study (Q-SET study)

Authors Erande S, Sarwardekar S, Desai B

Received 24 January 2019

Accepted for publication 20 March 2019

Published 21 June 2019 Volume 2019:12 Pages 961—967

DOI https://doi.org/10.2147/DMSO.S202458

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Melinda Thomas

Peer reviewer comments 2

Editor who approved publication: Dr Juei-Tang Cheng


S Erande,1 S Sarwardekar,2 B Desai3

1Department of Medicine, Akshay Hospital, Pune 411004, India; 2Department of Medicine, Sawardekar Clinic, Mumbai 400055, India; 3Department of Cardiology, Desai Heart Care Clinic, Mumbai 400092, India

Background: Newer therapies, such as dipeptidyl peptidase-IV inhibitors, are increasingly being used in the treatment of type 2 diabetes mellitus (T2DM). Teneligliptin, a DPP4 inhibitor, currently commonly used as monotherapy or as add-on therapy, was generally well tolerated in patients with T2DM during clinical trials. No AEs related to QT prolongation were detected with 40 mg/day of teneligliptin, but were seen at a supratherapeutic dose of 160 mg/day.
Aims and objective: To evaluate the safety of teneligliptin in type 2 diabetes patients with respect to QTc prolongation.
Methodology: This was an open-label, prospective, multi-centric trial conducted in patients with T2DM aged ≥18 to ≤65 years with a hemoglobin A1c (HbA1c) ≥7.0% and gliptin naïve. Teneligliptin 20 mg once a day was added to the standard treatment. The dose of teneligliptin was increased to 40 mg once a day if required, on the basis of glycemic parameters. Twelve-lead ECG was recorded at baseline and follow-up visits. The QTc was calculated by using the Bazett’s formula (QTc=QT/√RR).
Results: The mean QT interval at screening (Visit 1, Day 0, baseline ECG) was 0.33±0.07 seconds, while at visit 2 (Day 1, post 2 hours of Teneligliptin dosing) it was 0.32±0.04 seconds, at visit 3 (Day 15) it was 0.32±0.04 seconds, and at visit 4 (Day 90) it was 0.32±0.03 seconds. The mean QTc interval at baseline was 0.37±0.04 seconds, while at visit 2 it was 0.37±0.04 seconds, at visit 3 it was 0.37±0.03 seconds, and at visit 4 it was 0.37±0.03 seconds. There was a significant reduction in fasting blood glucose (P=0.002), postprandial blood glucose (P<0.001), and HbA1c (P<0.001) at the end of the 3 months as compared to baseline.
Conclusion: Teneligliptin at a therapeutic dose of 20 mg/day or 40 mg/day improved glycemic parameters significantly and did not cause QT/QTc interval prolongation.

Keywords: diabetes, teneligliptin, QT prolongation

A Letter to the Editor has been published for this article

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]