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Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen
Plain-language guide to PMID 15220016 (2004): open-label randomized controlled trial study of Insulin Detemir and NPH Insulin (isophane).
Key Facts
- PMID
- 15220016
- Journal
- Clinical therapeutics
- Year
- 2004
- Study type
- Randomized Controlled Trial
- Authors
- Russell-Jones D et al. (5 authors)
- DOI
- 10.1016/s0149-2918(04)90072-0
- Registered trial
- NCT03220425
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Insulin Detemir and NPH Insulin (isophane).
The purpose of this trial was to compare the effects of QD basal insulin replacement using insulin detemir versus neutral protamine Hagedorn (NPH) insulin in basal-bolus therapy in combination with regular human insulin (HI) in patients with type 1 diabetes mellitus (DM).
Who Took Part
PubMed indexes the participants as adults, both men and women.
Patients were randomly assigned (2:1) to 6 months of treatment with insulin detemir or NPH at bedtime in combination with HI with main meals.
How the Study Was Run
The design is described as randomized, open-label and parallel-group.
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.
This was a 6-month, prospective, randomized, open-label, controlled, parallel-group trial conducted at 92 sites in Europe and Australia.
Main outcome measures were blood glucose control as assessed by HbA(1c), fasting plasma glucose (FPG), 9-point self-monitored blood glucose (SMBG) profiles, 24-hour continuous blood glucose profiles, hypoglycemia, weight gain, and adverse events.
What Was Measured
PubMed files the paper under topics including Blood Glucose, Carrier Proteins, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Hypoglycemia, Hypoglycemic Agents and Insulin.
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 10 sentences; this page does not restate them, so read the paper for the findings and their limits.
The publication is from 2004 (Clinical therapeutics), a journal based in United States.
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.