A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

What Was Tested

This registered phase 1 trial tested Exenatide.

Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.

It had three arms (groups): Exenatide (experimental), Placebo (placebo comparator) and Moxifloxacin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 94 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Is overtly healthy, as determined by medical history and physical examination. Has body mass index (BMI) between 25 and 35 kg/m2.

The full record lists 5 inclusion and 4 exclusion criteria.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2011-02 with completion listed for 2011-04.

It ran at 2 sites in United States (2).

What Was Measured

Researchers chose this as the main measure: Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL) (time frame: Baseline, Day 1). Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL) (time frame: Baseline, Day 2). Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL) (time frame: Baseline, Day 3).

It also tracked 6 secondary outcomes, for example Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2, Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2, Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2, Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo and Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 94 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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