​Effect Of Teneligliptin On Qt Interval In Type Ii Diabetes Mellitus Patients: A Retrospective Evaluation

ABSTRACT

Background and Aim: According to a strict QT/QTc evaluation study and clinical studies for type 2 diabetes conducted in Japanand other countries, NO AEs related to QT prolongation were detected with 40 mg/day of teneligliptin, which is the maximaldosage used in clinical practice. So far, there are no data regarding the safety of teneligliptin in Indian type 2 diabetic patientswith respect to QTc prolongation. Therefore, the study was conducted to evaluate the safety of teneligliptin in type 2 diabeticpatients with respect to QT prolongation.Methods: A retrospective data were collected from type 2 diabetes mellitus patients with electrocardiogram (ECG) recordswho were treated with teneligliptin along with ongoing treatment. Primary endpoint was to compare the change in the ECGat 3 months from the baseline from the collected data. Mean daily dose (MDD) of antidiabetic drugs, HbA1c, fasting plasmaglucose (FPG), and postprandial plasma glucose (PPG) was also analyzed.Results: A total of 49 patients’ data were collected and analyzed with a mean age of 55.5 years and mean duration ofdiabetes 9.3 years. Hypertension was the most common comorbid disease (63.3%) along with diabetes for a mean durationof 10.0 years. Metformin plus glimepiride were the most prescribed dual drugs (63.3%) along with teneligliptin with an overallMDD of metformin (1065.2 mg) and glimepiride (2.1 mg). From the collected data, there was significant reduction in FPG andPPG at 3 months which were 49.6 mg/dL (P < 0.0001) and 100.5 mg/dL (P < 0.0001) reduction observed from the baseline,respectively. Significant changes were observed in the HbA1c from the baseline to 3 months (0.9%, P < 0.0001). There wasno significant increase in the mean QTc interval from baseline to 3 months. No serious adverse events or hypoglycemiawere reported.Conclusion: Teneligliptin was well tolerated with no significant change in QTc prolongation and significantly effective in reducingthe FPG, PPG, and HbA1c at 3 months from the baseline with no adverse events. There was no increase in the mean QT interval.