Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries.

Abstract

IntroductionInsulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (a basal insulin) and insulin aspart (a prandial insulin). The aim of this study was to investigate clinical outcomes in people with type 2 diabetes (T2D) after initiating IDegAsp treatment in a real-world setting.MethodsThis 26-week, open-label, non-interventional study was conducted in Australia, India, Malaysia, Philippines, Saudi Arabia, and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp from antidiabetic treatments (including oral antidiabetic drugs, basal insulin, basal–bolus insulin, premix insulin, and glucagon-like peptide 1 receptor agonist) per local clinical practice.ResultsCompared with baseline, there was significant improvement in HbA1c at end of study (EOS, first visit within weeks 26–36; estimated change − 1.4% [95% CI − 1.51; − 1.29]; P < 0.0001 [primary outcome]). From baseline to EOS, there were significant reductions in fasting plasma glucose (− 2.7 mmol/L [95% CI − 2.98; − 2.46]; P < 0.0001), body weight (− 1.0 kg [95% CI − 1.51; − 0.52]; P < 0.0001), and basal insulin dose in insulin-experienced participants (− 2.3 units [95% CI − 3.51; − 1.01]; P < 0.001). The incidence rates of non-severe (overall and nocturnal) and severe hypoglycaemia decreased significantly (P < 0.001) between the period before baseline and before EOS.ConclusionIn adults with T2D, initiating or switching to IDegAsp from previous antidiabetic treatment was associated with improved glycaemic control, lower basal insulin dose (in insulin-experienced participants), and lower rates of hypoglycaemia.Trial RegistrationClinical trial registration NCT04042441.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02212-3.