Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes

What Was Tested

The trial (phase 4) is built around Exenatide.

Yet, these non-glycemic effects are still largely unknown.

It had 1 arm (groups): 60 patients with T2DM (experimental).

These patients will be treated with exenatide once weekly for a period of 8 months.

The registry classes the interventions as drug.

More on the Plan

Clinical diagnostic tools will include the measurement of: 1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed angles of insonation; 2.

Endothelial dysfunction, that will be assessed by flow mediated dilation of brachial artery.

Biochemical analyses will include the analysis of: 1.

Routine testing: blood testing, liver and kidney profile, plasma lipids, glucose metabolism parameters; 2.

Who Took Part

The registry lists 60 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: Provision of informed consent prior to any study specific procedures;. Men and women with T2DM aged \>18 years;. BMI \>25 kg/m2;.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: pregnancy or willingness to become pregnant;; moderate and severe liver dysfunction;; moderate and severe renal failure;.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-01 with completion listed for 2016-07.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Subclinical atherosclerosis (as measured by cIMT) in patients with T2DM treated with exenatide once weekly (time frame: Change from baseline to 8 months of the treatment).

It also tracked 3 secondary outcomes, for example Oxidative stress (as measured by markers of oxidative stress) in patients with T2DM treated with exenatide once weekly and Endothelial dysfunction (as measured by flow mediated dilation of brachial artery) in patients with T2DM treated with exenatide once weekly.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Exenatide in 60 people.

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.