Efficacy and Safety of Teneligliptin as Add on Therapy in Indian Type 2 Diabetes Mellitus Patients having Dyslipidemia

Abstract

Objectives: The purpose of this study was to investigate the efficacy and safety of teneligliptin, a completely unique and highly selective DPP-4 inhibitor in type 2 diabetes mellitus (T2DM) patients having dyslipidemia who are inadequately controlled by relevant conventional therapy in India. Methods: Study protocol was approved by Institutional Ethics Committee. Diabetic patients having dyslipidemia (male/female) were randomized to receive treatments in two groups, namely conventional therapy [treatment (A)] and add on teneligliptin 20 mg with conventional therapy [treatment (B)] for 24 weeks. Predesigned case report form (CRF) was used to collect information from the prescribing physicians regarding the efficacy and safety of teneligliptin. Efficacy variables included change in serum glycaemic, lipid, and cytokines (IL-6, TNF-α and adiponectin) levels from baseline to week 24. Treatment-emergent adverse events (TEAEs) were also assessed. Results: A complete of 120 T2DM patient having dyslipidemia were analysed using graph pad prism. Teneligliptin, as add on therapy to conventional therapy significantly reduced serum lipid profile (TC, TG, and LDL) as well as glycaemic parameters (HbA1c, FBG, and PPBG) along with significant rise in serum adiponectin levels as compared to conventional therapy. Conclusion: Add- on therapy with teneligliptin was found better option over convetional therapy in term of significantly reduced glycemic as well as lipid profile. Further, it was found safe and well tolerated in T2DM patients having dyslipidemia.