Effectiveness of Ertugliflozin During Ramadan Fasting in Patients with Type 2 Diabetes Mellitus: A Real-World Study (ErtuRamadan study

Md Faruque Pathan ¹ Nazma Akter ² Marufa Mustari ³ M Saifuddin ⁴ Mirza Sharifuzzaman ⁴ Mohammad Motiur Rahman ⁵ Mohammed Ripon ⁶ S. M. Mohiuddin ⁷ A.B.M. Kamrul-Hasan ⁸ Md. Abdul Hannan Tareque ⁸ Muhammad Shah Alam ⁹ Samira Mahjabeen ¹⁰ Faria Afsana ¹¹ Muhammed Abu Bakar ¹² Tahniyah Haq ¹⁰ Afsar Ahammed Meraz ¹³ Samir Kumar Talukder ¹⁴ Sourav Sarkar ¹⁵ Shahjada Selim ^3*

• ¹ Director, Academy, Department of Endocrinology, BIRDEM, Dhaka-1000, Bangladesh, Dhaka, Dhaka, Bangladesh
• ² MARKS Medical College & Hospital, Dhaka, Bangladesh
• ³ Department of Endocrinology & Metabolism, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Dhaka, Bangladesh
• ⁴ Dhaka Medical College and Hospital, Dhaka, Dhaka, Bangladesh
• ⁵ Rajshahi Medical College, Rajshahi, Rajshahi, Bangladesh
• ⁶ Rangamati Medical College Hospital, Rangamati, Bangladesh
• ⁷ Sir Salimullah Medical College, Dhaka, Dhaka, Bangladesh
• ⁸ North East Medical College Hospital, Sylhet, Sylhet, Bangladesh
• ⁹ Army Medical College, Cumilla, Cumilla, Bangladesh
• ¹⁰ Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Dhaka, Bangladesh
• ¹¹ BIRDEM General Hospital, Dhaka, Dhaka, Bangladesh
• ¹² Chattagram Maa-O-Shishu Hospital Medical College, Chittagong, Chittagong, Bangladesh
• ¹³ National Institute of Neurosciences & Hospital, Agargoan, Dhaka, Bangladesh
• ¹⁴ Rangpur Medical College Hospital, Rangpur, Bangladesh
• ¹⁵ Boalkhali Upazila Health Complex, Chattogram, Bangladesh

Background: Management of type 2 diabetes mellitus (T2DM) during Ramadan fasting presents unique challenges due to prolonged fasting periods, irregular meal schedules, and altered medication timing, potentially impacting glycemic control. Ertugliflozin, a sodiumglucose co-transporter 2 (SGLT2) inhibitor, has been shown to improve glycemic control in T2DM effectively. However, the effectiveness of ertugliflozin during Ramadan fasting, a period with unique glycemic challenges, has not been studied extensively.Methods: This study was a multicenter, real-life experience study involving 1373 adult patients with known T2DM for at least one year, an HbA1c level of less than 10%, and who intended to fast during Ramadan. Participants were divided into two groups: the Ertu group (n=703), consisting of patients who had been on a stable dose of ertugliflozin for at least three months before Ramadan, and the non-Ertu group (n=670), which included patients receiving other oral antihyperglycemic drugs (OADs) except ertugliflozin. Patients attended a baseline visit two weeks before the first day of Ramadan and a follow-up visit within two weeks after the last day of Ramadan. Both visits included history taking, physical examinations, and laboratory tests. The primary endpoints were changes in HbA1c levels, body weight, body mass index (BMI), and the incidence of hypoglycemia during Ramadan fasting.The mean age of the study participants was 50.37 ± 11.14 (SD) years, with 40.6% male and 58.7% female. Patients receiving ertugliflozin showed significant reduction in HbA1C (-0.65 ± 0.67% vs. -0.22 ± 0.64%, p<0.001), body weight (-1.24 ± 2.58 kg vs. -0.36 ± 3.41 kg, p<0.001), and BMI (-0.48 ± 1.03 kg/m² vs. -0.11 ± 1.33 kg/m², p<0.001) compared to the non-Ertu group. Hypoglycemia was reported in 0.3% of the ertugliflozin group and 0.7% of the other group, with comparable adverse events (p=.23; ≥0.05), indicating a favorable safety profile for ertugliflozin during fasting.5 Conclusion: This study demonstrates that ertugliflozin is effective and safe for patients with T2DM during Ramadan fasting.