Empagliflozin versus Sitagliptin as add-on dual therapy in Egyptian patients with type 2 diabetes inadequately controlled with Metformin: a 12-week randomized, open-label, parallel-group trial

Abstract

Abstract Background Diabetes is one of the world’s most widespread conditions, and diabetic patients are among the most likely to engage in fierce battles with this chronic disease. Which group should be added-on as a dual therapy for Egyptian patients with type 2 diabetes and inadequate glycemic management, HbA1c ≥ 7.0% and ≤ 10% (≥ 53 and ≤ 86 mmol/mol), following not less than 3 months of metformin and diet therapy, is still up for debate. Based on this ambiguity, we designed our study to compare the safety and efficacy of sitagliptin 50 mg (n = 85) with empagliflozin 12.5 mg (n = 85) twice daily as an adjunctive therapy to metformin and diet for a further 12 weeks. HbA1c after 12 weeks of open-label therapy was the major outcome measure. Results After 12 weeks of treatment, empagliflozin drastically lowered HbA1c, FPG, PP, body weight, and triglycerides from baseline while significantly increasing LDL, total cholesterol, and HDL. On the other hand, sitagliptin significantly reduced FPG, PP (with a no discernable alteration in HbA1c), body weight, and triglycerides while significantly increasing HDL (P ≤ 0.001 for all comparisons). Comparing the two groups, empagliflozin significantly reduced HbA1c, FPG, and PP while significantly increasing LDL and triglycerides than sitagliptin (P < 0.001 for all except FPG, P = 0.005). More patients receiving empagliflozin 12.5 mg than sitagliptin 50 mg twice daily reported adverse events during open-label treatment (11.8% vs. 8.2%, respectively). Conclusions In type 2 diabetic Egyptian patients uncontrolled with metformin and diet, empagliflozin was superior to sitagliptin as regards glycemic control, weight, and SBP/DBP reduction.