To compare the efficacy and safety profile of empagliflozin and sitagliptin as an add on therapy to metformin in T2DM patients.

Abstract

Objective: To compare the efficacy and safety and profile of empagliflozin and sitagliptin as an add on therapy to metformin in T2DM patients. Study Design: Randomized Controlled Trial. Period: January to March 2024. Setting: Sheikh Zayed Medical College & Hospital, Rahim Yar Khan. Methods: A total of 280 T2DM patients with inadequate glycemic control on metformin were randomly assigned to receive either empagliflozin or sitagliptin. The primary outcomes included changes in body weight (BW), body mass index (BMI), fasting blood glucose (FBG), HbA1c, systolic and diastolic blood pressure (SBP, DBP), and lipid profile. Secondary outcomes involved monitoring adverse effects throughout the study. Results: After 12 weeks, both groups showed significant reductions in BW and BMI, with empagliflozin showing greater improvements (BW: 92.5±13.5 to 79±14.5 kg, BMI: 29.4±4.2 to 27.5±3.8) compared to sitagliptin (BW: 89±16.6 to 81±12.5 kg, BMI: 28.5±5.6 to 27.3±4.2). Similarly, empagliflozin more effectively reduced FBG (240±60.5 to 130±35.5 mg/dL) and HbA1c (8.35±1.9% to 7.2±1.6%) compared to sitagliptin. Both drugs were well-tolerated with no major adverse effects. Conclusion: Empagliflozin demonstrated superior efficacy and safety compared to sitagliptin as an add-on therapy to metformin in T2DM management.