Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial

What Was Tested

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

Who Took Part

By PubMed's age tags, the people studied were teenagers, young adults, adults and middle-aged adults, both men and women.

This multicentre, treat-to-target trial (Clinical trial registry: NCT02500706, ClinicalTrials.gov) randomized participants to double-blind mealtime faster aspart (n = 342) or IAsp (n = 342) or open-label post-meal faster aspart (n = 341).

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

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Being open-label, the Insulin Aspart study did not mask who received what.

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

The primary endpoint was change from baseline in HbA1c 26 weeks post randomization.

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.

The authors tagged it with the keywords clinical trial, hypoglycaemia, insulin therapy and type 1 diabetes.

What This Means in Plain Language

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

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2018 (Diabetes, obesity & metabolism), a journal based in England.

More context: the Insulin Aspart compound page.