QTc prolongation Safety and Effectiveness of Teneligliptin in Indian patients with type 2 Diabetes Mellitus: A real world study (QSET 2). Issue 5 (September 2021)

• Record Type: Journal Article
• Authors: Saboo, Banshi; Ghosh, Sujoy; Tiwaskar, Mangesh; Chawla, Rajeev
• Is Part Of: Diabetes & metabolic syndrome. Volume 15:Issue 5(2021)
• Publication Date: 2021-09
• Subjects: QTc interval -- HbA1c -- T2DM -- Teneligliptin; Diabetes -- Periodicals; Metabolism -- Disorders -- Periodicals; Diabetes Mellitus -- Periodicals; Metabolic Diseases -- Periodicals; Diabète -- Périodiques; Métabolisme, Troubles du -- Périodiques; Endocrinologie -- Périodiques; Diabète -- Physiopathologie -- Périodiques; Diabetes; Metabolism -- Disorders; Electronic journals; Periodicals; 616.462
• DOI: 10.1016/j.dsx.2021.102264
• Languages: English
• ISSNs: 1871-4021

Abstract

Abstract: Aims: To evaluate the safety with respect to QTc prolongation and effectiveness of Teneligliptin in Indian Type 2 Diabetes Mellitus (T2DM) patients. Methods: Retrospective data of T2DM patients on teneligliptin 20 mg or 40 mg once daily as a monotherapy or add-on therapy and having ECG records (before and after teneligliptin initiation) was collected. Safety was evaluated by change in QTc interval and effectiveness was evaluated by changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and haemoglobin A1C (HbA1c) from baseline to 12-weeks. Results: There was no significant change in mean QTc interval from baseline [418.68 milli seconds (ms) to 419 ms; mean change +0.33 ms; P = 0.1023] to follow up visit (mean duration 91 days). There was a significant reduction from baseline to 12 weeks in FPG [173.1 mg/dl (9.61 mmol/L) to 128.4 mg/dl (7.12 mmol/L), mean change - 44.64 mg/dl (2.47 mmol/L), P ≤ 0.001], PPG [242.5 mg/dl (13.46 mmol/L) to 176.5 mg/dl (9.79 mmol/L), mean change - 65.93 mg/dl (3.66 mmol/L), P ≤ 0.001], and HbA1c [8.2% (66 mmol/mol) to 7.2% (55 mmol/mol), mean change - 1.00% (10.9 mmol/mol), P ≤ 0.001]. Conclusion: Teneligliptin did not cause QTc interval prolongation and was significantly effective in improving glycemic control. Highlights: Large scale safety data regarding QTc prolongation and efficacy of Teneligliptin in Indian T2DM patients is lacking. In this study, initiation (20 mg) or up-titration dose (40 mg) of Teneligliptin did not cause QT/QTc prolongation. Teneligliptin also significantly reduced FPG, PPG, and HbA1c in Indian T2DM patients as monotherapy or add-on therapy. This study reinforces safety of Teneligliptin regarding QTc prolongation and efficacy in a larger Indian T2DM population.