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Similar progression of diabetic retinopathy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: a long-term, randomised, open-label study
Plain-language guide to PMID 19526210 (2009): open-label randomized controlled trial study of Insulin Glargine and NPH Insulin (isophane), diabetic retinopathy and glaucoma.
Key Facts
- PMID
- 19526210
- Journal
- Diabetologia
- Year
- 2009
- Study type
- Randomized Controlled Trial
- Authors
- Rosenstock J et al. (8 authors)
- DOI
- 10.1007/s00125-009-1415-7
What This Study Did, in Plain Language
What Was Tested
The paper reports a study of Insulin Glargine and NPH Insulin (isophane) in the context of diabetic retinopathy and glaucoma, published as a randomized controlled trial.
This long-term study was designed to further characterise the retinal safety profile of insulin glargine and human neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes mellitus.
The main objective of this study was to compare the progression of diabetic retinopathy between treatment groups by analysing the percentage of patients with three or more step progression in the ETDRS retinopathy patient-level severity scale after treatment with either basal insulin.
Who Took Part
PubMed indexes the participants as middle-aged adults and older adults, both men and women.
Patients were randomised by the investigator according to the centralised interactive voice response system to receive twice-daily NPH insulin (n = 509) or once-daily basal insulin glargine (n = 515).
The investigator was not blinded to the treatment group to which each participant had been assigned.
How the Study Was Run
In design terms this was a randomized, open-label, multicenter and parallel-group study.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
More than one site took part, so the participants came from several places.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Masked, centralised grading of seven-field stereoscopic fundus photographs was used.
What Was Measured
PubMed files the paper under topics including Blood Glucose, Canada, Diabetes Mellitus, Type 2, Diabetic Retinopathy, Disease Progression, Glycated Hemoglobin and Hypoglycemia.
What This Means in Plain Language
The paper is a randomized, open-label and multicenter study of Insulin Glargine and NPH Insulin (isophane) in people with diabetic retinopathy and glaucoma.
The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.
The publication is from 2009 (Diabetologia), a journal based in Germany.
More context: the Insulin Glargine compound page and the NPH Insulin (isophane) compound page, Diabetic retinopathy and glaucoma research.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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
- Diabetic retinopathy and glaucoma research
- Insulin Glargine in the library
- NPH Insulin (isophane) in the library
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.