The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes

What Was Tested

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

It had two arms (groups): Exenatide SC (Sub-study 1) (experimental) and Exenatide IV (Sub-study 2) (experimental).

The registry classes the interventions as drug.

More on the Plan

Two independent, double-blinded, crossover substudies will be conducted to test the effect of exenatide on daylong post-meal and fasting endothelial function.

The plan is to complete studies in 75 patients (40 in Substudy 1 and 35 in Substudy 2).

In Substudy 1 patients will get twice a day a skin injection of exenatide (Byetta) or identically looking placebo for 10 days, separated by 14-day period.

On the next day after each treatemnt period (day 11), they get just one injection and eat a fat-enriched breakfast.

Who Took Part

76 actual participants took part.

It was open to people of any sex aged from 35 years up to 70 years.

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

Examples of who could join: T2D diagnosed ≥ 5 years prior to study enrollment. Impaired glucose tolerance.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: known or suspected t1d (early onset age, low body mass index, lack of family history); TZD use in the prior 3 months; prior regular use of insulin.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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

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

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 2010-08 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Reactive Hyperemia Index (RHI) (time frame: 0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)).

It also tracked 2 secondary outcomes, for example Plasma Triglycerides and Plasma Glucose.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 76 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.