A Comparison of Efficacy among Syrian diabetic patients treated with Empagliflozin versus Dapagliflozin, a Randomized, Triple-blind, Two-period crossover study

Abstract

Objective: To directly compare the effectiveness of the highest approved doses of two sodium-glucose co-transporter 2 (SGLT2) inhibitors Empagliflozin and Dapagliflozin as part of Dual oral antidiabetic agents in type 2 diabetes (T2DM) patients. Methods: This study was a randomized, triple-blind, crossover, 24-week monocenter Trial. T2D Patients were randomized to receive metformin 1000mg b.i.d with Empagliflozin 25 mg/day and then metformin 1000mg b.i.d with Dapagliflozin 10mg/day (n=24) or vice versa (n=23). Each treatment period was 12 weeks with a 10-day washout period in between (without stopping metformin). The parameters evaluated at baseline and after 12 and 24 weeks. The primary outcome was the mean change from baseline in haemoglobin A1c (HbA1C), Fasting Blood Glucose (FBG), Body Mass Index (BMI), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP). Analyses were done per the Per-protocol principle. Results: Empagliflozin administration showed significant reductions in HBA1C, FBG, BMI, SBP and DBP (p>0.05), Dapagliflozin administration improved the levels of HBA1C, FBG, BMI, SBP and DBP but it was significant only in FBG (p=0.001) and SBP (p=0.035). There were no significant changes from baseline in HbA1c, FBG, SBP and DBP with Empagliflozin treatment compared with Dapagliflozin (P<0.05). Both groups showed reductions in BMI but the reduction was greater in the Empagliflozin group (between groups; p=0,044). Conclusions: This study showed that SGLT2 inhibitors can be effectively used as dual oral antidiabetic agents in T2D patients who are treated with metformin. More specifically, Empagliflozin was more effective in reducing BMI.