A Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide Modified Release during Fasting in Gulf Cooperation Council Countries: An Analysis from the International DIA-RAMADAN Study

Introduction: The safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) who fasted during Ramadan were previously published. Here, we carried out a regional analysis among patients living in Gulf Cooperation Council (GCC) countries. Patients and Methods: DIA-RAMADAN was a real-world, observational, international, noncomparative study conducted in nine countries that included >1200 T2DM adults receiving gliclazide MR for at least 90 days before inclusion. The study comprised 2 visits: at inclusion, 6.8 weeks before the start of Ramadan (V0) and 4.6 weeks after the end of Ramadan (V1). The primary endpoint was the proportion of patients reporting .1 symptomatic hypoglycemic event as collected using a patient diary. Changes in HbA_1c, fasting plasma glucose (FPG), and weight were also analyzed. This manuscript represents data collected in GCC countries (Kuwait, Saudi Arabia, and United Arab Emirates). Results: Data from 161 patients were analyzed: mean (SD) age 56.8 (10.6) years, 30.4% women, body mass index 29.1 (3.7) kg/m², T2DM disease duration 6.7 (3.3) years, baseline HbA_1c 7.9% (0.8). The proportions of patients reporting .1 symptomatic hypoglycemic event or confirmed hypoglycemia during Ramadan were 4.3% and 0.6%, respectively. No cases of severe hypoglycemia were reported. Significant reductions in main variables were observed before the start of Ramadan (V0) and 4.6 weeks after the end of Ramadan (V1): HbA_1c (from 7.9 [0.8] to 7.6 [0.7]%; p value <0.001), FPG (from 143.5 [24.3] to 137.9 [25.2] mg/dL; p value = 0.031), and weight (from 79.0 [73.0. 86.0] to 78.0 [72.0.85.0] kg; p value = 0.018). Conclusions: These real-world data indicate that patients with T2DM treated with gliclazide MR during Ramadan in the selected GCC countries have a low risk of hypoglycemia and maintain glycemic control and weight while fasting.