Introduction & Objective: Oral semaglutide, a glucagon-like peptide 1 receptor agonist, should be administered in empty stomach, with up to 120 ml of water and with no food, beverages or any oral medications intake for a minimum of 30-min post administration to ensure optimal systemic absorption. These instructions could be cumbersome to follow during Ramadan when patients fast for longer duration. This O-SEMA-Fast sub-analysis assessed impact of fasting on adherence to oral semaglutide dosing instructions and subsequently on glycemic and body weight changes.
Methods: O-SEMA-Fast was a non-interventional, prospective study in people with T2D who fasted during Ramadan and on oral semaglutide treatment in United Arab Emirates, Saudi Arabia and Kuwait. Patients were followed up for a period of 20-weeks (end of study, EOS). HbA1c and body weight were measured at baseline and at EOS; changes were analyzed by mixed models for repeated measures.
Results: Of 257 patients in the full analysis set, 215 were eligible as they had recorded administration details in their diaries. Among these, 68.4% (n=147) were found to be adherent to oral semaglutide dosing instructions for ≥80% of days the diary was filled. At baseline, mean HbA1c was 6.69% and 7.0% in adherent and non-adherent (dosing instructions) people, respectively. At EOS, an estimated change in HbA1c from baseline was -0.33 (95% CI: -0.44, -0.23; p<0.0001) and -0.12 (95% CI: -0.36, 0.12; p=0.3138), respectively. Similarly, change in body weight was -3.22 kg (95% CI: -4.03, -2.40, p<0.0001) and -1.64 (95%CI: -2.45, -0.84, p=0.0001), in adherent and non-adherent people.
Conclusion: This O-SEMA Fast sub-analysis indicated that most people adhered to oral semaglutide administration instructions and experienced significant decrease in HbA1c and body weight, making oral semaglutide as a suitable choice of drug for people who fast during Ramadan.
M. Hassanein: Research Support; Novo Nordisk A/S. Advisory Panel; Sanofi. Speaker's Bureau; Abbott, Boehringer-Ingelheim, Medtronic. Advisory Panel; Eli Lilly and Company. I. AlKadhim: Speaker's Bureau; Lilly Diabetes. Research Support; IQVIA Inc. Advisory Panel; Novo Nordisk. Speaker's Bureau; Boehringer-Ingelheim, AstraZeneca, Novo Nordisk. H. Aly: Employee; Novo Nordisk. Stock/Shareholder; Novo Nordisk. D. Bajawi: Consultant; Novo Nordisk, Boehringer-Ingelheim, AstraZeneca, Sanofi. T. Cinar: Employee; Novo Nordisk. D. Dhanwal: Research Support; Novo Nordisk A/S. A. Jabbar: Research Support; Novo Nordisk A/S. S. Khader: Research Support; IQVIA Inc., Novo Nordisk. K. Khudadah: None. T. Muzaffar: Other Relationship; Novo Nordisk. M. Ngome: Employee; Novo Nordisk. J. Nafach: None. A. Shaghouli: None.