AIMS: To evaluate the long-term safety and efficacy of a simplified basal-bolus regimen of once-daily insulin degludec/insulin aspart (IDeg @entity2574 ) with additional IAsp vs. a standard basal-bolus insulin regimen of insulin detemir (IDet) with IAsp in adults with Type  1 @entity6 . METHODS: This was an open-label trial compromising a 26-week core phase followed by a 26-week extension phase. @entity1 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 @entity413 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/ @entity1 -years of exposure (PYE) with IDegAsp+ @entity2574 and 36.7  episodes/PYE with IDet+IAsp, and the rate of nocturnal confirmed hypoglycaemia was significantly lower with IDegAsp+ @entity2574 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 @entity6 . This article is protected by copyright. All rights reserved.

Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in XXXX with Type  1 @entity6 : 1-year results from a randomized clinical trial (BOOST(  ) T1).

@entity1 :: ('9606', 'Species') :: ['Participants', 'people'] @entity2574 :: ('CHEBI:22660', 'Chemical') :: ['Asp'] @entity413 :: ('MESH:D005947', 'Chemical') :: ['glucose'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes']
@entity1 :: (9606,Species) :: ['people']
