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Pharmacokinetics of diluted (U20) insulin aspart compared with standard (U100) in children aged 3-6 years with type 1 diabetes during closed-loop insulin delivery: a randomised clinical trial

Plain-language guide to PMID 25537835 (2015): open-label randomized controlled trial study of Insulin Aspart.

Key Facts

PMID
25537835
Journal
Diabetologia
Year
2015
Study type
Randomized Controlled Trial
Authors
Ruan Y et al. (7 authors)
DOI
10.1007/s00125-014-3483-6

What This Study Did, in Plain Language

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart.

FUNDING was provided by the JDRF, 7th Framework Programme of the European Union, Wellcome Trust Strategic Award and the National Institute for Health Research Cambridge Biomedical Research Centre.

Who Took Part

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

Young children with type 1 diabetes underwent an open-label, randomised, two-period crossover study in a clinical research facility, 2-6 weeks apart.

The researchers measured the time-to-peak insulin concentration (tmax), insulin metabolic clearance rate (MCR(I)) and background insulin concentration (ins(c)) using compartmental modelling.

How the Study Was Run

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

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

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

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

Plasma insulin was measured every 30-60 min from 17:00 hours on day 1 to 8:00 hours on day 2.

What Was Measured

PubMed files the paper under topics including Blood Glucose, Diabetes Mellitus, Type 1, Drug Monitoring, Hypoglycemic Agents, Insulin Aspart, Insulin Infusion Systems and Models, Biological.

What This Means in Plain Language

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

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2015 (Diabetologia), a journal based in Germany.

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

Our Notes on the Compound

Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.