Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy

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.

More on the Plan

The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis.

It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis.

Exenatide is an GLP-1 receptor agonist.

Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 25 years up to 70 years.

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

Examples of who could join: Newly diagnosed type 2 diabetes without drug treatment. 25-70 years old age. Females who have no plan of pregnancy during the study.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: acute or chronic complications of diabetes; myocardial infarction or cerebrovascular events within three months; serious gastrointestinal diseases.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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 2014-02 with completion listed for 2015-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: time to glycaemic remission (time frame: up to 1 year). remission rate of type 2 diabetes at a year (time frame: up to 1 year).

It also tracked 1 secondary outcome, for example the beta cell function change.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.