Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary Bypass

What Was Tested

This registered phase 3 trial tested Exenatide.

Clinical data on the effects of GLP-1 agonists on cardiac function and glucose control in patients undergoing cardiac surgery are not known.

Based on the results of experimental studies there is a potential for exenatide to positively influence both cardiac function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes mellitus.

It had two arms (groups): Exenatide (experimental) and Control (no intervention).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Elective coronary artery bypass grafting operation (CABG). Age 18 to 85. Signed informed consent. Females with childbearing potential have to use appropriate contraceptive measures during the whole study period and 6 months after terminating exenatide infusion (hormonal contraception or double-barrier contraception for both partners).

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: allergy to exenatide; allergy to insulin; mental incapacity or language barrier.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

The Exenatide group and the comparison group ran side by side rather than switching.

In this single-blind Exenatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2011-06 with completion listed for 2014-05.

It ran at 1 site in Czechia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cardiac function - echocardiographic parameters (time frame: 90 days after administration of exenatide).

It also tracked 1 secondary outcome, for example Number of participants with adverse effects.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 38 people.

Its size is small, so on its own it can only give an early look.

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.