Randomized Clinical Trial on Efficacy of Empagliflozin Versus Sitagliptin, In Addition to Metformin in Type 2 Diabetic Patients

Abstract

Introduction

Diabetes mellitus is a syndrome affecting more than 28.7 million people worldwide and its prevalence in Pakistan is reported to be about 11%. Management includes lifestyle changes and varied therapeutic regimens. Metformin (MET) alone and in combinations is considered as an important agent for glycemic control. Our study is based on MET combination therapy with empagliflozin versus sitagliptin in order to achieve glycemic control.

Methods

This randomized clinical trial was conducted in the Department of Medicine and Allied of Federal Government Polyclinic Hospital, Islamabad, from January 2022 till June 2022. The ethical approval letter numbered FGPC. 1-1/2022/Ethical Committee was taken before the commencement of the trial. The patients were divided into group A and group B. All patients were given MET 1000mg twice a day. Group A patients were additionally given sitagliptin 50mg twice daily whereas Group B patients were additionally given empagliflozin 10mg once daily. Glycemic control was documented with HbA1c at the start of treatment and after three months of treatment in both groups. A proforma was used to collect data. Analysis of the data was performed using the Statistical Package for the Social Sciences version 17 (SPSS Inc., Chicago, USA).

Results

A total of 126 patients were included in the study with a mean age of 53.53 ± 6.49. 81.7% were males while 18.3% were females. The mean reduction in HbA1c from baseline in group A was -0.81 ± 0.19% and in group B was -1.13 ± 0.24% with statistically significant p-value (p-value = 0.000).

Conclusion

Empagliflozin in combination with metformin is more efficacious in maintaining glycemic control as compared to sitagliptin in combination with metformin.