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

What Was Tested

Researchers studied Insulin Aspart in this randomized controlled trial publication.

Who Took Part

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

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 (HbA1c) after 26 weeks of treatment.

How the Study Was Run

The researchers set it up as a randomized, double-blind, open-label and multicenter study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

More than one site took part, so the participants came from several places.

A time span of 12 weeks appears in the methods.

All available information regardless of treatment discontinuation was used for the evaluation of treatment effect.

What Was Measured

The subject headings attached to it are Blood Glucose, Diabetes Mellitus, Type 1, Drug Combinations, Glycated Hemoglobin, Hypoglycemia, Hypoglycemic Agents and Insulin Aspart.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Insulin Aspart over 12 weeks.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2019 (Diabetes care), a journal based in United States.

More context: the Insulin Aspart compound page, all human trials.