Intravenous Exenatide (Byetta) During Surgery

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Exenatide.

It had three arms (groups): one (experimental), one (experimental) and Placebo IV NSS (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The researchers will use a block number of 30 (please see power analysis) so that balance between each of the three groups will be maintained over the enrollment period.

The researchers will stratify the randomization scheme to ensure balance of diabetics and non-diabetics within the groups.

Who Took Part

The registry lists 104 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: Age (\>18 years). Weight of \> 50 kg and \< 150 kg. Ability to provide informed consent. Elective surgery including:. Abdominal aortic aneurysm repair.

The full record lists 11 inclusion and 26 exclusion criteria; among the exclusions: age (\<18 years); inability to provide informed consent; history or risk of pancreatitis (e.g. ethanol abuse, gall stones).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

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

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2009-03 with completion listed for 2016-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The Primary Objective is to Determine the Ability of Intravenous Exenatide to: Maintain Intraoperative Euglycemia in Subjects With Initial Blood Glucose < [amount hidden]/dL in Surgical Subjects as Compared to Placebo,.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Exenatide in 104 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.