Introduction: Fasting in patients with type 2 diabetes mellitus (T2DM) is associated with high risk of hypoglycemia. The aim of this study was to compare the effectiveness and safety of vildagliptin in T2DM patients fasting during Ramadan in a real-life setting in Egypt.
Methods: In this 16-week prospective and noninterventional study, data were collected up to 6 weeks before and after Ramadan fasting. Patients who had received vildagliptin or sulfonylurea (SU) either as dual therapy with metformin or as monotherapy were enrolled into the study.
Results: Two hundred fifty four patients were enrolled in the study, out of which 246 [121 (97.6%) treated with vildagliptin and 125 (99.2%) with SU] were included in the safety analysis set. A significantly lower proportion of patients experienced ≥1 hypoglycemic event (HE) with vildagliptin as compared to those receiving SUs (1.7% vs. 19.2%, respectively; p < 0.001). No patient in either group reported a grade 2 HE. At week 16, mean change in HbA1c from baseline for vildagliptin and SU were -0.1% and +0.3%, respectively, with a between-treatment difference of -0.4% (p < 0.001). Mean change in body weight from baseline for vildagliptin and SU were -0.8 and -0.1 kg, with a between-treatment difference of -0.7 kg (p = 0.011). A higher proportion of SU-treated patients experienced adverse events compared to those treated with vildagliptin (23.2% vs. 5.8%, respectively), the primary reason being the high incidence of hypoglycemia in the SU group (n = 24, 19.2%).
Conclusions: Treatment with vildagliptin was associated with lower incidence of hypoglycemia compared with SU and showed good glycemic and weight control in patients with T2DM fasting during Ramadan in a real-life setting in Egypt.
Funding: Novartis Pharma AG.
Keywords: Dipeptidyl peptidase-4 inhibitors; Hypoglycemia; Metformin; Ramadan; Type 2 diabetes; Vildagliptin.