The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Exenatide and Insulin Glargine.

The main goals of the study are to evaluate the effect of Exenatide on endothelial-dependent vasodilation, as measured by flow mediated dilation (FMD), to evaluate the effect on endothelial-independent vasodilation, as measured by nitroglycerin (TNG) response, and to evaluate the effect on arterial stiffness, as measured by pulse wave analysis (PWA).

The researchers will also measure the effects on various markers of endothelial function, subclinical inflammation, fibrinolysis, and oxidative stress.

The control group for the study will receive Lantus insulin, with a goal of similar glycemic control between the treatment and control groups.

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

The registry classes the interventions as drug.

More on the Plan

The trial is a randomized, controlled, comparator study.

Subjects and investigators will not be blinded due to the nature of the treatment.

A computer program (randomization.com) will be utilized to randomize 72 patients to receive either Exenatide or Lantus.

The subjects on Lantus should achieve this goal by week 6 of the study, so that they have six weeks of maximal therapy.

Who Took Part

Enrollment: 72 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: HbA1c: above 7.0 and less than or equal to 10.0. Reproductive age females must have negative urine HCG at screening, and be using appropriate contraception during the study or be surgically sterile. Stable weight for 3 months prior to study (+/- 2kg). Willingness to participate in the study.

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: hba1c less than 7.0 or greater than 10; age less than 18 or greater than 75; pregnant or planning to become pregnant during study period.

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.

The Exenatide group and the comparison group ran side by side rather than switching.

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

It started in 2006-08 with completion listed for 2010-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The Primary Endpoint Was the Change in FMD at the End of the Study Compared to Baseline Measurements in Subjects Treated With Exenatide Compared to Subjects Treated With Lantus (time frame: Baseline and End of Study).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 72 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 and the Insulin Glargine compound page, all human trials.