Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial

What Was Tested

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

Liraglutide is a human glucagon-like peptide receptor analog approved for use in patients with 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.

To formally assess the cardiovascular safety of liraglutide, the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial was commenced in 2010.

Patients with T2DM at high risk for cardiovascular disease (CVD) who were either drug naive or treated with oral antihyperglycemic agents or selected insulin regimens (human NPH, long-acting analog, or premixed) alone or in combination with oral antihyperglycemics were eligible for inclusion.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

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

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Liraglutide could be set against what happens without it.

Running at several centres spread the Liraglutide study over different clinics and patient groups.

The timeline in the abstract includes 5 years.

LEADER is a phase 3B, multicenter, international, randomized, double-blind, placebo-controlled clinical trial with long-term follow-up.

Randomized patients are being followed for up to 5 years.

What Was Measured

Topics PubMed links to this paper include Cardiovascular Diseases, Diabetes Mellitus, Type 2, Glucagon-Like Peptide 1, Hypoglycemic Agents and Liraglutide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Liraglutide over 5 years.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2013 (American heart journal), a journal based in United States.

More context: the Liraglutide compound page.