Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects

What Was Tested

The trial (phase 4) is built around Exenatide.

The aim of the study is to use Exenatide long-acting release (LAR) \[Bydureon\] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation.

It had two arms (groups): one (experimental) and Humulin kwickpen (active comparator).

The registry classes the interventions as drug.

More on the Plan

Standard care for post myocardial infarction will be given after PCI.

Insulin NPH + Metformin alone: in cardiac and endothelial functions.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients eligible for PCI with application of DES, due to ACS. Patients with known or newly diagnosed T2D (type 2 diabetes is diagnosed according to current WHO criteria or by the use of anti-diabetic drugs). Male and female subjects 18-80 years. Signed informed consent form.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: type 1 diabetes (autoantibody positive); any history of receiving glp-1 analogues or dipeptidyl peptidase inhibitors within 6 months; known severe heart failure, classified as nyha 4.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-12 with completion listed for 2022-08.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The degree of non-covered stent struts by Bydureon add on to Insulin over that of Insulin as analyzed by optical coherence tomography (OCT) (time frame: 12 weeks).

It also tracked 15 secondary outcomes, for example Fractional Flow Reserve (FFR), Coronary Flow velocity Reserve (CRF), Index of Microcirculatory Resistance (IMR), Fractional flow reserve positive re-stenosis, Target lesion failure and Acute coronary syndrome (ACS) and/or repeat revascularization.

What This Means in Plain Language

Put simply, this is a phase 4, 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.