Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study

What Was Tested

Researchers studied Liraglutide in this randomized controlled trial publication.

Liraglutide is a once-daily human GLP-1 analog being developed as a Type 2 diabetes therapy.

Who Took Part

The study group was 24 men.

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

Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.

Subjects remained at the study site from Day 21 until the end of the trial, with standard meals served during inhouse periods.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

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

Blinding on both sides kept the men and researchers unaware of who received Liraglutide.

Some men received a placebo instead of Liraglutide, giving a reference point.

What Was Measured

Topics PubMed links to this paper include Area Under Curve, Blood Glucose, Diabetes Mellitus, Type 2, Glucagon-Like Peptide 1, Half-Life, Hypoglycemic Agents and Japan.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Liraglutide in 24 men.

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 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 2008 (International journal of clinical pharmacology and therapeutics), a journal based in Germany.

More context: the Liraglutide compound page.