Safety and Efficacy of Semaglutide Use in Diabetes during Ramadan Fasting: A Real-world Experience from Bangladesh

Abstract

Aims: The study has been conducted to observe the efficacy and safety of once-weekly subcutaneous semaglutide during Ramadan fasting among patients with type 2 diabetes mellitus (T2DM) from Bangladesh who intended to fast during Ramadan 2022. Methods: This was an open-label, single-center, two-arm parallel-group study. In this prospective observational study, patients were enrolled in two groups depending on treated with or without semaglutide for at least 3 months prior Ramadan. Initially, total 200 patients were enrolled at the first visit (4 weeks before Ramadan); among them, 58 subjects were in the semaglutide group (Group A) and 142 in other than the semaglutide group (Group B). At the end of the second visit (within 4 weeks after Ramadan) after data editing and cleaning, a total of 130 patients (55 subjects in Group A and 75 subjects in Group B) were included in the final statistical analysis. All of them were followed up for a total of 24 weeks including 12 weeks of screening period. The primary objectives were to assess the efficacy and safety of semaglutide in terms of glycosylated hemoglobin (HbA1c) (%), weight loss (kg), hypoglycemia (number of events), and episodes of gastrointestinal (GI) upset (number of events) during Ramadan fasting. Results: Patients in the semaglutide group had better glycemic control after fasting of Ramadan compared to the control group (mean decrease in HbA1c level: 0.61% vs. 0.19%; P < 0.001). In addition, more than 18% of the patients in the semaglutide group achieved good glycemic control (HbA1c <7%), while the rate was 13.3% in the control group. Patients treated with semaglutide achieved a better weight loss than the nonsemaglutide group (2.97 vs. 1.38 kg; P < 0.001). Although there was no significant difference in terms of hypoglycemic events in both the groups (P = 0.13), but the GI symptoms were more common in the semaglutide group than the control group (P < 0.05). Among other secondary endpoints, the serum levels of total cholesterol, low-density lipoprotein, and triglyceride were significantly decreased in the semaglutide group compared to the control group (P < 0.05). Conclusions: Semaglutide showed better efficacy in glycemic control, weight loss, and dyslipidemia compared to other hypoglycemic drugs in patients with T2DM during Ramadan. Although patients receiving semaglutide reported fewer hypoglycemic episodes and GI upset events, they might be subjected to other medications or prolonged fasting. Semaglutide might be considered a suitable therapy during Ramadan fasting based on judicial judgment.