IDF21-0675 IDegAsp treatment was associated with improved glycaemic control and reduced hypoglycaemia rates: a real-world study

Abstract

Background: Insulin degludec/insulin aspart (IDegAsp) has been shown to provide effective glycaemic control with reduced rates of hypoglycaemia compared with other insulin regimens in a large phase 3 clinical trial programme in people with type 2 diabetes (T2D). Aim: To evaluate glycaemic control and investigate the incidence of hypoglycaemia in people with T2D after initiating or switching to IDegAsp from any anti-diabetic treatment (including oral anti-diabetic drugs [OADs], basal insulin, basal–bolus insulin, premix insulin and glucagon-like peptide-1 receptor agonist [GLP-1 RA] ± insulin) in real-world clinical practice across six countries. Method: This was a 26-week, open-label, non-interventional study (NCT04042441) conducted in Australia, India, Malaysia, Philippines, Saudi Arabia and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp as per local clinical practice. The incidence of self-reported non-severe hypoglycaemic episodes (overall and nocturnal), occurring within 4 weeks prior to IDegAsp initiation (baseline) and 4 weeks prior to end of study (EOS, first visit from week 26–36), and self-reported severe hypoglycaemic episodes, occurring within 26 weeks prior to baseline and 26 weeks prior to EOS, were analysed using a negative binomial regression model. Results: Compared with baseline, there was a significant improvement in HbA1c at EOS (baseline HbA1c [standard deviation], 9.8% [1.99]; estimated change: –1.4% [–1.51;–1.29]95%CI; p < 0.0001 [primary endpoint]). There was also a significant reduction in fasting plasma glucose from baseline to EOS (estimated change: –49.0 mg/dL [–53.77;–44.29]95%CI; p < 0.0001). The overall incidence rates of severe, non-severe and non-severe nocturnal hypoglycaemia decreased significantly between the period prior to baseline and the period before EOS (Table). Discussion: Overall, in a broad, real-world population of adults with T2D, initiating or switching to IDegAsp was associated with improved glycaemic control and significantly lower rates of severe, non-severe and non-severe nocturnal hypoglycaemia.