The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

What Was Tested

This registered phase 4 trial tested Exenatide.

It had two arms (groups): Exenatide (experimental) and Metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Greater than or equal to 18 years old. Abdominal obesity: waist circumference \>102 cm (men) and \>88 cm (women). Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: current use of glycemic control medications within one month of randomization; current use of weight loss medication; previous weight loss surgery.

How the Study Was Run

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

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

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

Being open-label, the Exenatide study did not mask who received what.

It started in 2007-10 with completion listed for 2011-07.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Reactive Hyperemic Index Over the 3-month Treatment Period (time frame: Change from baseline to 3 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 50 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.