Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial

What Was Tested

The paper reports a study of Insulin Aspart, published as a randomized controlled trial.

Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co-formulation of basal and bolus insulin.

Who Took Part

The age groups tagged for this paper are infants, young children, children and teenagers, both men and women.

Children and adolescents (aged 1 to <18 years) with T1D.

Patients were randomized 1:1 (age stratified: 1-<6 years; 6-<12 years; 12-<18 years) to IDegAsp once daily (OD) plus insulin aspart (IAsp) for remaining meals (IDegAsp + IAsp), or IDet OD or twice daily plus mealtime IAsp (IDet + IAsp).

How the Study Was Run

The design is described as randomized, open-label and parallel-group.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Groups ran in parallel: each of the participants stayed in one arm throughout.

The primary end-point was HbA1c change from baseline at week 16.

What Was Measured

The subject headings attached to it are Diabetes Mellitus, Type 1, Drug Combinations, Hypoglycemia, Hypoglycemic Agents, Insulin, Long-Acting and Ketosis.

Author keywords: adolescent, child, insulin degludec/insulin aspart, insulin detemir and type 1 diabetes.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin Aspart.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2018 (Pediatric diabetes), a journal based in China.

More context: the Insulin Aspart compound page.