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A single-dose euglycaemic clamp study in two cohorts to compare the exposure of SAR341402 (insulin aspart) Mix 70/30 with US- and European-approved versions of insulin aspart Mix 70/30 and SAR341402 rapid-acting solution in subjects with type 1 diabetes
Plain-language guide to PMID 33236518 (2021): double-blind randomized controlled trial study of Insulin Aspart in 1, subjects.
Key Facts
- PMID
- 33236518
- Journal
- Diabetes, obesity & metabolism
- Year
- 2021
- Study type
- Randomized Controlled Trial
- Authors
- Kapitza C et al. (6 authors)
- DOI
- 10.1111/dom.14260
- Registered trial
- NCT03916601
What This Study Did, in Plain Language
What Was Tested
Researchers studied Insulin Aspart in this randomized controlled trial publication.
Who Took Part
According to the abstract, 1, subjects were involved.
In cohort 1, subjects (N = 36) were exposed once each to SARAsp -Mix, NN-Mix-US and NN-Mix-EU.
In cohort 2, subjects (N = 16) were exposed once each to SARAsp -Mix and SAR-Asp.
How the Study Was Run
In design terms this was a randomized, double-blind and crossover study.
Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.
Neither the subjects nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.
In the crossover set-up each of the subjects took both Insulin Aspart and the comparison in turn, acting as their own control.
This was a randomized, double-blind, crossover trial in two cohorts.
What Was Measured
Topics PubMed links to this paper include Blood Glucose, Diabetes Mellitus, Type 1, Glucose Clamp Technique, Hypoglycemic Agents and Insulin Aspart.
What This Means in Plain Language
The paper is a randomized, double-blind and crossover study of Insulin Aspart in 1, subjects.
With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.
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 2021 (Diabetes, obesity & metabolism), a journal based in England.
More context: the Insulin Aspart compound page.
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.