Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day

What Was Tested

The paper reports a study of Lixisenatide, published as a randomized controlled trial.

The aim of this study is to explore whether administration timing affects glycaemic control by lixisenatide once-daily in type 2 diabetes mellitus (T2DM).

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults and older adults, both men and women.

A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.

Patients were administered lixisenatide before breakfast or the main meal.

How the Study Was Run

In design terms this was a randomized, open-label and multicenter study.

Random assignment meant chance, not the researchers, decided who got Lixisenatide and who got the comparison, which limits bias.

Being open-label, the Lixisenatide study did not mask who received what.

More than one site took part, so the participants came from several places.

The primary endpoint was change from baseline at week 24 in glycated haemoglobin (HbA1c).

Other endpoints: changes in body weight, fasting plasma glucose (FPG), 7-point self-monitored plasma glucose (SMPG) and Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score.

Adverse events (AEs) were monitored.

What Was Measured

The subject headings attached to it are Blood Glucose, Breakfast, Glycated Hemoglobin, Hypoglycemic Agents, Meals, Peptides and Postprandial Period.

Author keywords: Flexibility, Glycaemic control, Lixisenatide, Self-monitored plasma glucose and Type 2 diabetes mellitus.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Lixisenatide.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2014 (Journal of diabetes and its complications), a journal based in United States.

More context: the Lixisenatide compound page.