← Human Trials & Peer-Reviewed Studies
Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial
Plain-language guide to PMID 23094597 (2013): open-label randomized controlled trial study of Insulin Aspart and NPH Insulin (isophane) in 347 subjects.
Key Facts
- PMID
- 23094597
- Journal
- Diabetic medicine : a journal of the British Diabetic Association
- Year
- 2013
- Study type
- Randomized Controlled Trial
- Authors
- Thalange N et al. (5 authors)
- DOI
- 10.1111/dme.12041
- Registered trial
- NCT00435019
What This Study Did, in Plain Language
What Was Tested
Researchers studied Insulin Aspart and NPH Insulin (isophane) in this randomized controlled trial publication.
NPH (neutral protamine Hagedorn) insulin, in combination with insulin aspart, in subjects aged 2-16 years with Type 1 diabetes mellitus.
Who Took Part
The study group was 347 subjects.
PubMed indexes the participants as young children, children and teenagers, both men and women.
Of the 347 randomized and exposed subjects, 177 received insulin detemir and 170 NPH insulin, both administered once or twice daily in combination with mealtime insulin aspart.
Glycaemic measurements and weight were followed over 52 weeks.
How the Study Was Run
The researchers set it up as a randomized, open-label and parallel-group 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.
Nothing was hidden in this open-label Insulin Aspart study: the subjects and staff both knew the treatment.
Groups ran in parallel: each of the subjects stayed in one arm throughout.
A time span of 52 weeks appears in the methods.
What Was Measured
PubMed files the paper under topics including Blood Glucose, Body Mass Index, Diabetes Mellitus, Type 1, Europe, Glycated Hemoglobin, Hypoglycemic Agents and Insulin Aspart.
What This Means in Plain Language
The paper is a randomized, open-label and parallel-group study of Insulin Aspart and NPH Insulin (isophane) in 347 subjects over 52 weeks.
With several hundred people or more, it is a fairly large study for this kind of research.
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 2013 (Diabetic medicine : a journal of the British Diabetic Association), a journal based in England.
More context: the Insulin Aspart compound page and the NPH Insulin (isophane) compound page.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
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.