Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial

Abstract

Background Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co‐formulation of basal and bolus insulin. Objective To evaluate efficacy and safety of IDegAsp in pediatric patients with type 1 diabetes (T1D). Subjects Children and adolescents (aged 1–95%CI (–0.45 mmol/mol [–2.51; 1.60]_95%CI), confirming non‐inferiority. There were no significant differences between treatment groups in fasting or self‐measured plasma glucose. Confirmed hypoglycemia rates did not significantly differ between groups. There was a significant reduction in basal and total insulin dose with IDegAsp+IAsp versus IDet+IAsp (post hoc analysis). Mean number of injections/day was 3.6 and 4.9 with IDegAsp+IAsp and IDet+IAsp, respectively (post hoc analysis). A non‐significant higher rate of severe hypoglycemia was observed with IDegAsp+IAsp versus IDet+IAsp. The most frequent adverse events in both groups were hypoglycemia, headache and nasopharyngitis. Conclusions IDegAsp+IAsp was non‐inferior to IDet+IAsp regarding HbA1c, had similar hypoglycemia rates and required fewer injections.