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Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes
Plain-language guide to PMID 17227321 (2007): open-label randomized controlled trial study of Insulin Detemir and NPH Insulin (isophane).
Key Facts
- PMID
- 17227321
- Journal
- Diabetic medicine : a journal of the British Diabetic Association
- Year
- 2007
- Study type
- Randomized Controlled Trial
- Authors
- Robertson KJ et al. (6 authors)
- DOI
- 10.1111/j.1464-5491.2007.02024.x
- Registered trial
- NCT00312156
What This Study Did, in Plain Language
What Was Tested
Researchers studied Insulin Detemir and NPH Insulin (isophane) in this randomized controlled trial publication.
This study compared the effect of insulin detemir on glycaemic control (HbA(1c), fasting plasma glucose and variability thereof) with that of Neutral Protamine Hagedorn human isophane (NPH) insulin, both combined with insulin aspart, in children with Type 1 diabetes mellitus, and compared the safety of these treatments.
Who Took Part
By PubMed's age tags, the people studied were children and teenagers, both men and women.
In this 26-week, open-label, randomized (2 : 1), parallel-group study, 347 (140 prepubertal and 207 pubertal) children with Type 1 diabetes, aged 6-17 years, received insulin detemir (n = 232) or NPH insulin (n = 115) once or twice daily, according to the prestudy regimen, plus premeal insulin aspart.
How the Study Was Run
The researchers set it up as a randomized, open-label and parallel-group study.
Random assignment meant chance, not the researchers, decided who got Insulin Detemir and who got the comparison, which limits bias.
Everyone knew when Insulin Detemir was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Groups ran in parallel: each of the participants stayed in one arm throughout.
What Was Measured
Topics PubMed links to this paper include Diabetes Mellitus, Type 1, Drug-Related Side Effects and Adverse Reactions, Glucose Tolerance Test, Hypoglycemia, Hypoglycemic Agents, Insulin and Insulin Detemir.
What This Means in Plain Language
The paper is a randomized, open-label and parallel-group study of Insulin Detemir and NPH Insulin (isophane).
The abstract goes on to report its results in about 7 sentences; this page does not restate them, so read the paper for the findings and their limits.
The publication is from 2007 (Diabetic medicine : a journal of the British Diabetic Association), a journal based in England.
More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page.
Our Notes on the Compounds
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
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.