← Human Trials & Peer-Reviewed Studies
Effect of a single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase I randomized trial
Plain-language guide to PMID 31050109 (2019): open-label randomized controlled trial study of Insulin Glargine and Lixisenatide in 20 participants.
Key Facts
- PMID
- 31050109
- Journal
- Diabetes, obesity & metabolism
- Year
- 2019
- Study type
- Randomized Controlled Trial
- Authors
- Inoue M et al. (5 authors)
- DOI
- 10.1111/dom.13757
- Registered trial
- NCT02713477
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Insulin Glargine and Lixisenatide.
The primary endpoint was area under the postprandial plasma glucose (PPG) curve (AUC0-2h ).
Who Took Part
The abstract describes 20 participants taking part.
By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.
How the Study Was Run
The researchers set it up as a randomized, open-label, placebo-controlled and crossover study.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
The comparison arm used a placebo, so changes seen with Insulin Glargine could be set against what happens without it.
In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.
What Was Measured
The primary endpoint was area under the postprandial plasma glucose (PPG) curve (AUC0-2h ).
PubMed files the paper under topics including Blood Glucose, Diabetes Mellitus, Type 2, Drug Combinations, Glycated Hemoglobin, Hypoglycemia, Hypoglycemic Agents and Insulin Glargine.
Author keywords: GLP-1 analogue, basal insulin, glycaemic control and phase I-II study.
What This Means in Plain Language
The paper is a randomized, open-label and placebo-controlled study of Insulin Glargine and Lixisenatide in 20 participants.
With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.
The publication is from 2019 (Diabetes, obesity & metabolism), a journal based in England.
More context: the Insulin Glargine compound page and the Lixisenatide compound page.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
Lixisenatide: A 44-amino-acid once-daily GLP-1 receptor agonist based on exendin-4; sold as Adlyxin/Lyxumia and in Soliqua with insulin glargine.
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.