Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial.

ABSTRACT:

Objective

To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes.

Research design and methods

After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart (n = 260), mealtime IAsp (n = 258), or open-label postmeal faster aspart (n = 259). The primary end point was change from baseline in glycated hemoglobin (HbA_1c) after 26 weeks of treatment. All available information regardless of treatment discontinuation was used for the evaluation of treatment effect.

Results

At week 26, mealtime and postmeal faster aspart were

SUBMITTER: Bode BW 

PROVIDER: S-EPMC6973646 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature