Safety Study of Repeated Doses of Glucagon on Animal Starch in the Liver

What Was Tested

This registered not phased trial tested Glucagon.

It had 1 arm (groups): Open-Label Glucagon (experimental).

The registry classes the interventions as drug.

More on the Plan

The difficulty of delivering regular or analog insulin in such a manner is related to its slow onset and prolonged effect when delivered subcutaneously.

Glucagon, a hormone secreted from the alpha cells of the normal endocrine pancreas, rapidly raises circulating glucose levels within minutes via glycogenolysis, even when given subcu-taneously.

Glucagon is approved for use as a parenteral injection for treatment of severe hypoglycemia.

The comparisons will be made when glycogen stores should be replete (after a lunch meal) and when glycogen stores should be lower (after an overnight fast).

Who Took Part

12 actual participants took part.

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

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

Examples of who could join: Current usage of subcutaneous insulin pump treatment. Age 18-65 years. BMI 18-35 kg/m2. Willingness to follow all study procedures, including attending all clinic visits. Willingness to sign informed consent and HIPAA documents.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: pregnancy or lactation: for women of childbearing potential: there is a requirement for a negative urine pregnancy test; congestive heart failure, nyha class ii, iii or iv; coronary artery or cerebrovascular disease.

How the Study Was Run

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

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

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

It started in 2011-01 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration (time frame: Baseline and 41 hours).

It also tracked 1 secondary outcome, for example Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration.

What This Means in Plain Language

Put simply, this is a not phased trial of Glucagon in 12 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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