Exenatide at therapeutic and supratherapeutic concentrations does not prolong the QTc interval in healthy subjects

What Was Tested

Researchers studied Exenatide in this randomized controlled trial publication.

This randomized, placebo- and positive-controlled, crossover, thorough QT study evaluated the effects of therapeutic and supratherapeutic exenatide concentrations on QTc .

To assure proper heart rate correction, a wide range of baseline heart rates was assessed and prospectively defined methodology was applied to determine the optimal QT correction.

Who Took Part

The age groups tagged for this paper are teenagers, adults, middle-aged adults and older adults, both men and women.

Intravenous infusion was employed to achieve steady-state supratherapeutic concentrations in healthy subjects within a reasonable duration (i.e. days).

Subjects received exenatide, placebo and moxifloxacin, with ECGs recorded pre-therapy and during treatment.

How the Study Was Run

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

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

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

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

What Was Measured

Topics PubMed links to this paper include Anti-Bacterial Agents, Aza Compounds, Electrocardiography, Exenatide, Fluoroquinolones, Heart Rate and Hypoglycemic Agents.

What This Means in Plain Language

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

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2013 (British journal of clinical pharmacology), a journal based in England.

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