Investigating Imeglimin Safety and Efficacy in Patients with Type 2 Diabetes Mellitus During Fasting in Ramadan

Background: Fasting during Ramadan is a challenge for those with type 2 diabetes mellitus (T2DM). Imeglimin is a new oral antidiabetic medicine that works in two ways and has a minimal risk of causing hypoglycemia and/or hemodynamic changes. These advantages make imeglimin a possible choice for use during Ramadan. Objective: The goal was to examine the safety and effectiveness of imeglimin versus vildagliptin in individuals with T2DM who were fasting during Ramadan. Materials and Methods: A total of 126 adults with T2DM were randomly assigned (1:1) to receive either imeglimin [1000 mg twice daily (BID)] or vildagliptin (50 mg BID), along with metformin. Changes in glycated hemoglobin (HbA1c) and the frequency of hypoglycemic and/or hyperglycemic episodes were the main outcomes. Patients were checked 4–6 weeks before and after Ramadan. Results: After Ramadan, both groups had significant decreases in HbA1c. The imeglimin group had a bigger drop (14.2% vs. 7.5%; P < 0.001 between groups, P = 0.227 within groups). The imeglimin group had fewer hypoglycemic ( P = 0.02) and hyperglycemic episodes ( P = 0.001) during fasting. The body mass index decreased more in the imeglimin group ( P = 0.02) but not in the vildagliptin group ( P = 0.084). There were no clinically significant changes in liver enzymes or kidney function in either group. Conclusion: Imeglimin and metformin together are a safe and effictive treatment for people with T2DM who are willing to fast during Ramadan.