Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

What Was Tested

The trial (phase 1) is built around Exenatide.

Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers.

It had four arms (groups): IV exenatide - pilot study (other), Treatment Group A - core study (experimental), Treatment Group B - core study (experimental) and Treatment Group C - core study (experimental).

The registry classes the interventions as drug.

More on the Plan

This single-center Phase I study will consist of 2 parts, a Pilot Part and a Core Part.

Who Took Part

The registry lists 82 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: Body mass index (BMI) between 19 to 35 kg/m2 inclusive. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), and bilirubin within normal range at Screening. Fasting triglycerides within the normal range at Screening.

The full record lists 4 inclusion and 25 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes, or history of hypoglycemia; history of atrial fibrillation, flutter, or non-sustained or sustained vt; history of uncontrolled hypertension.

How the Study Was Run

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

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

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, care provider, investigator and outcomes assessor.

It started in 2016-01 with completion listed for 2016-04.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pilot Study: Establishment of mean plasma steady state concentration of 500 pg/mL (time frame: 35 days). Core Study: Changes to QTc interval changes (threshold > 10 msec) measurements (time frame: 56 days).

It also tracked 15 secondary outcomes, for example Pilot Study: Adverse events as assessed by subjective subject reporting, laboratory testing, ECG, physical examinations, and vital signs, Core Study: Measurement of exenatide plasma concentrations and relationship to changes in QTc interval measurements, Core Study: Changes in PR, RR, QRS, QT, T- and U- wave morphology, Core Study: Measurement of QTc interval changes moxifloxacin as active control, Core Study: Adverse events as assessed by subjective subject reporting, laboratory testing, ECG, physical examinations, and vital signs and Pilot Study: Maximum concentration (CMax) of exenatide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 82 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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