Abstract

OPEN LABELLED RANDOMIZED COMPARATIVE STUDY OF EMPAGLIFLOZIN AND METFORMIN COMBINATION V/S METFORMIN AND GLIMIPIRIDE COMBINATION IN KNOWN TYPE II DIABETES MELLITUS PATIENTS

Dr. B. Deepika*, Dr. G. Preethi Prathyusha, R. Anusha Sri, Shazia Tabassum and R. Vinay Kumar

Abstract

The current focus of research is an antidiabetic agent – SGLT-2 inhibitor(Empagliflozin) that can improve glycemic control without increasing hypoglycemia, can promote weight loss. The purpose of this study is to evaluate the efficacy of empagliflozin and metformin combination therapy compared with metformin and glimepiride combination therapy in patients with type II diabetes mellitus. A Randomized, Open Labeled, Parallel Group, Prospective Study was conducted from Dec 2016- May 2017 at a 350-beded Tertiary Care teaching hospital in South India.A total of 140 Patients with HBA1C ≥ 7% were divided into Group A and Group B. The primary end point was the change in FPG, PPG, HBA1C level from baseline at week 24. Key secondary end points were changes were from baseline in Body Weight, BMI, BP at week 24. At week 24 mean changes from baseline in FPG were: in Group A 168±64.9, in Group B 185±63.4; PLPG were: in Group A 141±84.08, in Group B 141±84.33; HBA1C were: in Group A - 1±0.3,in Group B -1±0.3; SBP: in Group A -11±11.1, in Group B 9±11.5; BMI, Body Weight were reduced. Hypoglycemic attacks were reported in Group A. Urinary tract infections were reported in Group B.Empagliflozin 10 mg OD for 24 weeks as an add on therapy to metformin and glimepiride combination compared with metformin and glimepiride combination resulted in similar changes in HBA1C, FPG, PPG, Body Weight, BMI and BP and was well tolerated.

Keywords: Diabetes Mellitus, Empagliflozin, Metformin, Glimepiride.