Efficacy and safety of combination of empagliflozin and metformin with combination of sitagliptin and metformin during Ramadan: an observational study

Background Management of diabetes during fasting is a clinical challenge. Sodium glucose co-transporter -2 inhibitors (SGLT2i) are considered safe with a low risk of hypoglycemia. However, studies on SGLT2i are scarce. This study was designed to compare the efficacy, safety, and tolerability of empagliflozin with metformin during Ramadan in comparison with sitagliptin and metformin. Methods It was a prospective, observational study, conducted at 11 different sites all across Pakistan on an outpatient basis during Ramadan (May 2021-June 2021). including 132 patients, 88 who received metformin and sitagliptin, and 44 patients who received metformin and empagliflozin. Results Patients of the SGLT-2i group experienced similar symptomatic hypoglycemic episodes (15.9%) as the sitagliptin group. There was an improvement in blood sugar levels after the use of SGLT-2i (RBS 181 [+ or -] 64 before Ramadan vs 162 [+ or -] 53 after Ramadan). HbA1c also improved after the use of SGLT-2i before and after Ramadan (7.2 [+ or -] 0.8 vs 6.9 [+ or -] 0.9 for Metformin + Empagliflozin and 7.8 [+ or -] 1.5 vs 7.6 [+ or -] 1.6 for Metformin and sitagliptin). Weight and BMI improved after the use of SGLT-2i (BMI 36.5 [+ or -] 4.8 before Ramadan and 33.7 [+ or -] 2.4 after Ramadan). There were no reported cases of urinary tract infection in the empagliflozin group. Conclusion SGLT-2 inhibitors combined with metformin for patients with diabetes during Ramadan fasting is as effective, safe and well tolerated as DPP4 combined with metformin. Keywords: Diabetes, Ramadan, Fasting, Hypoglycemia