1035-P: Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL (Gla-300) in People with Type 2 Diabetes (T2DM) Who Fast during Ramadan: Regional Analysis of the ORION Study

ORION, a prospective observational study, evaluated the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people who fast during Ramadan. Adults (≥18 years) with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks before inclusion and intended to continue during Ramadan were enrolled in 11 countries (grouped by region; Table). Mean (SD) number of fasting days was 30.1 (3.2). Mean diabetes duration ranged from 7.9 to 13.5 years and ≥77.5% had moderate/low risk associated with fasting (investigator-assessed). Proportions of people with ≥1 severe and/or symptomatic documented hypoglycemia event were low for the overall population and in Groups 1-3; 1 severe hypoglycemia event was reported in pre-Ramadan. Glycemic control improved pre- to post-Ramadan in Groups 1-3 and Gla-300 dose adjustments were minimal. In Canada, 24% of people had ≥1 severe and/or symptomatic documented hypoglycemia event in Ramadan; there was no change in glycemic control, but pre-Ramadan HbA1c target achievement was high (30.4%). In this real-world study, people with T2DM who received Gla-300 and fasted for Ramadan generally had low incidence of hypoglycemia, with no severe events in Ramadan, and slightly improved glycemic control; results from Canada varied, possibly due to longer fasting hours.