Abstract
ORION was a prospective, observational study evaluating the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people with type 2 diabetes (T2DM) who fast during Ramadan. Adults with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks prior to inclusion, and intended to continue its use during Ramadan were enrolled in 11 countries. During Ramadan, Gla-300 treatment was adjusted as per routine practice by the treating physician. Overall, the majority of people (402 [85%]) fasted for the entire Ramadan period and 10.8% fasted for ≥25 days but with at least one missed day. Mean (SD) age was 54.4 (11.0) years, 51.7% were male, BMI was 29.7 (5.3) kg/m2, and duration of diabetes was 10.7 (7.0) years. Risks of diabetes-related complications associated with fasting were assessed by physicians according to IDF-DAR fasting risk category; risk was low/moderate in 82.8%, high in 14.3%, and very high in 2.9% of people. The proportion of people with ≥1 severe and/or documented symptomatic (SMPG ≤70 mg/dL) hypoglycemia event was low (2.2% [event rate: 0.021 per participant-month (PPM)] in pre-Ramadan, 2.6% [0.039 PPM] in Ramadan and 0.2% in post-Ramadan [0.003 PPM]). Overall, 0.8% (0.005 PPM) of participants experienced severe and/or documented symptomatic hypoglycemia at SMPG <54 mg/dL, and only during pre-Ramadan. No participants had severe hypoglycemia during Ramadan or post-Ramadan; 1 participant had severe hypoglycemia pre-Ramadan. Most of those who experienced symptomatic hypoglycemia during Ramadan did so during fasting hours (11/13 people). Reductions were shown pre- to post-Ramadan for mean (SD) HbA1c (8.10 % [1.29] pre-Ramadan to 7.64 % [1.05] post-Ramadan; change of −0.44 % [0.97]), FPG (144.3 [45.8] mg/dL pre-Ramadan to 128.5 [37.8] mg/dL post-Ramadan; change of −13.5 [44.1] mg/dL), and fasting SMPG (130.7 [32.9] mg/dL pre-Ramadan to 126.8 [28.5] mg/dL post-Ramadan; change of −3.3 [26.6] mg/dL). Mean Gla-300 dose was reduced slightly between pre-Ramadan and Ramadan (25.6 [11.9] U/0.32 [0.14] U/kg pre-Ramadan to 24.4 [11.5] U/0.30 [0.13] U/kg in Ramadan) and returned to 26.0 (12.2) U/0.32 (0.14) U/kg in the post-Ramadan period. AE incidence was low (5.5%); 3 (0.6%) participants had an AE of hyperglycemia, 2 (0.4%) during Ramadan. In this study, performed in a real-world setting, incidence of hypoglycemia was low in people with T2DM treated with Gla-300 who fasted for Ramadan, with no incidence of severe hypoglycemia during the Ramadan period; HbA1c, FPG and fasting SMPG reductions were also observed. Supported By: Sanofi
Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study