Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes

What Was Tested

This randomized controlled trial paper looks at Liraglutide.

The objective of this study was to establish effects of liraglutide on the QTc interval.

Why It Was Studied

Four different models for QT correction were used: QTci, as the primary endpoint, and QTciL, QTcF, and QTcB as secondary endpoints.

Who Took Part

The abstract describes 51 participants taking part.

PubMed indexes the participants as teenagers, adults and middle-aged adults, both men and women.

How the Study Was Run

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

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

A time span of 7 days appears in the methods.

What Was Measured

Four different models for QT correction were used: QTci, as the primary endpoint, and QTciL, QTcF, and QTcB as secondary endpoints.

PubMed files the paper under topics including Aza Compounds, Diabetes Mellitus, Type 2, Drug Evaluation, Preclinical, Electrocardiography, Fluoroquinolones, Glucagon-Like Peptide 1 and Heart Conduction System.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Liraglutide in 51 participants over 7 days.

The publication is from 2009 (Journal of clinical pharmacology), a journal based in England.

More context: the Liraglutide compound page.