Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

Investigators anticipate these studies will provide novel information about the temporal relationship between Bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.

It had two arms (groups): Bydureon (experimental) and Placebo (placebo comparator).

Injectable medication Bydureon.

A similar looking injectable.

The registry classes the interventions as drug.

More on the Plan

Participants are expected to have a wide range of cardiovascular (CVD) risk and will therefore allow them to explore the importance of disease extent at baseline as a predictor of response.

Blocked randomization will be used to ensure equal distribution of gender and CVD history.

Carotid plaque MRI assessments will be performed at baseline, 9 and 18 months.

Who Took Part

The registry lists 148 planned participants were the target.

It was open to people of any sex aged from 21 years up to 75 years.

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

Examples of who could join: Must have a regular primary care provider (PCP) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: type 1 diabetes mellitus (t1dm); current or recent glucagon-like peptide 1 receptor (glp-1r) agonist use; contraindications to mri (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for mri exam).

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

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

It started in 2014-06 with completion listed for 2019-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in carotid plaque volume (time frame: 18 months).

It also tracked 2 secondary outcomes, for example Change in reactive hyperemic index and Change in carotid plaque composition.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 148 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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