Evaluation of Teneligliptin a DPP4 Inhibitor in Terms of Efficacy and Safety with Respect to QT/QTc Prolongation in Patients with Type II Diabetes Mellitus (T2DM).

INTRODUCTION: Low risk of hypoglycemia and weight neutrality have increased the administration of dipeptidyl peptidase 4 (DPP-4) inhibitors in patients with T2DM in clinical practice. Currently Teneligliptin is prescribed as a second or third add on to the standard treatment with other classes of oral hypoglycemic agents (OHAs) to achieve targeted glycemic control in type 2 DM patients. METHODS: An open label, interventional, single arm, 12 weeks study was conducted on160 patients with type 2 DM at MGM Medical College, Aurangabad with Teneligliptin 20 mg once a day as add on to the ongoing standard treatment with other classes of OHAs. Changes in glycemia parameters like FBS, PPBS HbA1C, body weight were assessed and twelve lead ECG was recorded with safety assessment at baseline and follow-up visits.. The QTc was calculated by using the Bazett's formula (QTc=QT/√RR).The study was conducted with an objective to assess efficacy and safety of Teneligliptin with respect to QT/QTc prolongation in patients with T2DM. RESULTS: A significant reduction was seen in the glycemic parameters like FBS, PPBS HbA1C from the baseline values (P<0.001) but no significant change in the QT interval (P=0.9563) and QTc interval (P=0.5594) from the baseline to the end of study at12 weeks. CONCLUSION: Tenelegliptin is a promising new drug to help to achieve targeted glycemic control in patients with T2DM without prolonging the QT/QTc interval.