Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon

What Was Tested

The trial (phase 4) is built around Glucagon.

It had two arms (groups): Glucagon with Ethanol (experimental) and Glucagon without Ethanol (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 21 years up to 80 years.

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

Examples of who could join: Age 21 to 80 years old with type 1 diabetes for at least one year. Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), or insulin glulisine (Apidra) for at least one week prior to enrollment. Alcohol exposure on at least one occasion in the last year consisting of at least 4 drinks in one sitting.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: unable to provide informed consent; unable to comply with study procedures; unable to refrain from the consumption of alcohol at least 24 hours prior to study start.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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.

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

It started in 2016-03 with completion listed for 2017-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AOCGIR (Area Over the Curve for Glucose Infusion Rate) (time frame: 1 Day Visit (approximately 8 to 11 hours)).

It also tracked 1 secondary outcome, for example Maximum Change in GIR (Glucose Infusion Rate) From Baseline.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in 26 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.