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Effect of the fast-acting insulin analog lispro on the risk of nocturnal hypoglycemia during intensified insulin therapy. U.K. Lispro Study Group
Plain-language guide to PMID 10526722 (1999): open-label randomized controlled trial study of Insulin Lispro in 165 subjects.
Key Facts
- PMID
- 10526722
- Journal
- Diabetes care
- Year
- 1999
- Study type
- Randomized Controlled Trial
- Authors
- Heller SR et al. (3 authors)
- DOI
- 10.2337/diacare.22.10.1607
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Insulin Lispro.
Who Took Part
The study group was 165 subjects.
By PubMed's age tags, the people studied were adults, both men and women.
In 11 diabetes outpatient clinics in the U.K., 165 subjects with type 1 diabetes were enrolled in a randomized crossover open-label study with a 2-month run-in period and then treated with a basal bolus regimen.
Patients used human NPH insulin at night with either premeal insulin lispro for 4 months followed by human regular insulin for another 4 months or human regular insulin for 4 months followed by insulin lispro for another 4 months.
How the Study Was Run
The researchers set it up as a randomized, open-label and crossover study.
Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.
Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.
The methods mention a period of 4 months.
The main outcome measures were the number of hypoglycemic episodes during both treatments and HbA1c level.
What Was Measured
PubMed files the paper under topics including Blood Glucose, Circadian Rhythm, Diabetes Mellitus, Type 1, Diabetic Neuropathies, Diabetic Retinopathy, Glycated Hemoglobin and Hypoglycemia.
What This Means in Plain Language
The paper is a randomized, open-label and crossover study of Insulin Lispro in 165 subjects over 4 months.
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 1999 (Diabetes care), a journal based in United States.
More context: the Insulin Lispro compound page, all human trials.
Our Notes on the Compound
Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.
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.