A thorough QT study to evaluate the effects of singledose exenatide [amount hidden] on cardiac repolarization in healthy subjects

What Was Tested

The paper reports a study of Exenatide and Glucagon, published as a randomized controlled trial.

This was a singledose, randomized, positive- and placebo-controlled, double-dummy, double-blinded, 3-period crossover thorough QT study of exenatide, a glucagon-like peptide-1 receptor agonist for the treatment of Type 2 diabetes that enhances insulin secretion in a glucose- dependent fashion.

Who Took Part

By PubMed's age tags, the people studied were teenagers, adults, middle-aged adults and older 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 Exenatide and who got the comparison, which limits bias.

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

Some participants received a placebo instead of Exenatide, giving a reference point.

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

Twelve-lead electrocardiograms and blood samples for plasma exenatide, glucose, and insulin were collected.

QT intervals were heart rate-corrected using Fridericia's correction (QTcF) and an individual correction (QTcI) and were analyzed as change from predose (ΔQTcF, or ΔQTcI).

The relationships between the QTc interval and plasma exenatide, glucose, and insulin concentrations were also explored.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Electrocardiography, Exenatide, Glucagon-Like Peptide-1 Receptor, Heart Rate, Hypoglycemic Agents and Insulin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Exenatide and Glucagon.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2011 (International journal of clinical pharmacology and therapeutics), a journal based in Germany.

More context: the Exenatide compound page and the Glucagon compound page, all human trials.