Glucagon Regulation of Glucose Metabolism

What Was Tested

The trial (phase 1) is built around Glucagon.

Glucagon is a 30 amino acid peptide hormone that is produced exclusively in alpha-cells of the pancreatic islets.

It had three arms (groups): Glucagon at basal glycemia (experimental), Glucagon at hyperglycemia (experimental) and Glucagon at hyperglycemia with GLP-1R blockade (experimental).

The registry classes the interventions as drug.

More on the Plan

Subjects will have a screening visit for history, medication usage, and blood work; those who qualify will be offered participation.

All studies will start following withdrawal of several basal samples over an extended period: 1.

Glucose concentrations will be measured at the bedside using a YSI glucose analyzer.

Plasma samples will be collected at 10 minute intervals for assay of insulin, C-peptide, and glucagon.

Who Took Part

19 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

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

It started in 2019-09-24 with completion listed for 2021-04-16.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in insulin secretion (time frame: before and after glucagon administration, up to 1 hour). hepatic glucose production (time frame: before and after glucagon administration, up to 1 hour).

It also tracked 2 secondary outcomes, for example Change in Glucagon concentrations and Change in Beta-hydroxybutyrate concentrations.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 19 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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