Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal–bolus treatment in people with Type 1 diabetes: 1–year results from a randomized clinical trial ( BOOST ®T1)

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Aims To evaluate the long‐term safety and efficacy of a simplified basal–bolus regimen of once‐daily insulin degludec/insulin aspart (IDegAsp) with additionalIAsp vs. a standard basal–bolus insulin regimen of insulin detemir (IDet) withIAsp in adults with Type 1 diabetes. Methods This was an open‐label trial comprising a 26‐week core phase followed by a 26‐week extension phase. Participants were randomized toIDegAsp once daily at the main meal andIAsp at remaining meals (IDegAsp+IAsp), orIDet (once or twice daily) andIAsp at all meals (IDet+IAsp). Insulins were titrated to target plasma glucose of < 5 mmol/l (< 90 mg/dl) at pre‐breakfast (IDegAsp andIDet) and at pre‐meal (IAsp). Results After 52 weeks, the overall confirmed hypoglycaemia rate was 31.8 episodes/patient‐years of exposure (PYE) withIDegAsp+Asp and 36.7 episodes/PYEwithIDet+IAsp, and the rate of nocturnal confirmed hypoglycaemia was significantly lower withIDegAsp+Asp than withIDet+IAsp (3.1 vs. 5.4 episodes/PYE, respectively;P <0.05). Adverse event rates were comparable between groups. Mean HbA1cdecreased from baseline by 0.7% (IDegAsp+IAsp) and 0.6% (IDet+IAsp), achieving 60 or 61 mmol/mol (7.6% or 7.7%, respectively), at Week 52. The mean total daily insulin dose was lower withIDegAsp+IAsp than withIDet+IAsp (ratio: 0.87; 95%CI0.79–0.95;P= 0.0026). Conclusions Once‐daily treatment withIDegAsp andIAsp as bolus insulin for remaining meals was associated with significantly lower risk of nocturnal confirmed hypoglycaemia, improved glycaemic control and showed non‐inferiority compared withIDet+IAsp, the standard of care in Type 1 diabetes.