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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 additional IAsp vs. a standard basal-bolus insulin regimen of insulin detemir ( IDet) with IAsp 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 to IDegAsp once daily at the main meal and IAsp at remaining meals ( IDegAsp+ IAsp), or IDet (once or twice daily) and IAsp at all meals ( IDet+ IAsp). Insulins were titrated to target plasma glucose of < 5 mmol/l (< 90 mg/dl) at pre-breakfast ( IDegAsp and IDet) and at pre-meal ( IAsp). Results After 52 weeks, the overall confirmed hypoglycaemia rate was 31.8 episodes/patient-years of exposure ( PYE) with IDegAsp+Asp and 36.7 episodes/ PYE with IDet+ IAsp, and the rate of nocturnal confirmed hypoglycaemia was significantly lower with IDegAsp+Asp than with IDet+ IAsp (3.1 vs. 5.4 episodes/ PYE, respectively; P < 0.05). Adverse event rates were comparable between groups. Mean HbA1c decreased 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 with IDegAsp+ IAsp than with IDet+ IAsp (ratio: 0.87; 95% CI 0.79-0.95; P = 0.0026). Conclusions Once-daily treatment with IDegAsp and IAsp as bolus insulin for remaining meals was associated with significantly lower risk of nocturnal confirmed hypoglycaemia, improved glycaemic control and showed non-inferiority compared with IDet+ IAsp, the standard of care in Type 1 diabetes. [ABSTRACT FROM AUTHOR]