Insulin degludec/insulin aspart (IDegAsp) is the first soluble co-formulation that combines two insulin analogues.
Aims and Objectives:
To assess the efficacy and safety of IDegAsp administered once-daily (OD) plus meal-time IAsp for remaining meals in controlling glycaemia as assessed by change in HbA1c from baseline in a paediatric population.
A 16-week, 1:1, open-label, parallel group, randomised, treat-to-target trial.
Children aged 1–5 years (n=82), 6–11 years (n=122), 12–17 years (n=158) with a diabetes duration of 1.6–6.0 years, HbA1c of 7.9–8.3% and fasting plasma glucose (FPG) of 8.1–8.6 mmol/L (all range of means at baseline) were randomised to receive either IDegAsp OD+meal-time IAsp for remaining meals (n=182) or insulin detemir (IDet)+meal-time IAsp (n=180). IDegAsp was non-inferior (limit 0.4%) to IDet for change in HbA1c (estimated treatment difference [ETD] –0.04 [–0.23; 0.15]95%CI), which was accomplished with a numerically lower basal insulin dose: IDegAsp+IAsp: 0.36 vs IDet+IAsp; 0.5 U/kg. ETD for FPG at Week 16 was 0.31 (–0.70; 1.33)95%CI. Rates of confirmed hypoglycaemia were 46.2 (IDegAsp+IAsp) vs 49.6 (IDet+IAsp) events/patient-years of exposure (PYE) (estimated ratio [ER] 0.95 [0.76; 1.17]95%CI). Rates of nocturnal hypoglycaemia were 5.77 (IDegAsp+IAsp) vs 5.40 (IDet+IAsp) events/PYE (ER 1.09 [0.81; 1.48]95%CI). Rates of severe hypoglycaemia were 0.26 (IDegAsp+IAsp) vs 0.07 (IDet+IAsp) events/PYE (ER 3.20 [0.88; 11.66]95%CI; p=ns). Rates of hyperglycaemic episodes with ketosis were 0.11 (IDegAsp+IAsp) vs 0.22 events/PYE (IDegAsp+IAsp) (ER 0.44 [0.11; 1.74]95%CI) and ETD for body weight SD scores was 0.07 (0.02; 0.12)95%CI. Adverse event profiles were similar.
IDegAsp+IAsp was non-inferior to IDet+IAsp for change in HbA1c, at a numerically lower basal insulin dose. There were no significant differences in rates of confirmed or severe hypoglycaemia between IDegAsp+IAsp and IDet+IAsp. IDegAsp+IAsp offers an alternative to basal–bolus treatment with one injection of combination insulin per day.