Safety and Efficacy of ZP-Glucagon to Injectable Glucagon for Hypoglycemia

What Was Tested

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

The purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.

It had four arms (groups): one (experimental), one (experimental), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Eligible subjects giving informed consent will be randomised to a treatment sequence of each of the four treatments in one week intervals.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: any history of hypoglycemic coma or hypoglycemic seizures; any episode of severe hypoglycemia (requiring treatment) within one month prior to study start; any history of pheochromocytoma or insulinoma.

How the Study Was Run

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

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2015-01 with completion listed for 2015-08.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of subjects achieving normoglycemia (time frame: 30 minutes).

It also tracked 5 secondary outcomes, for example Time at which normoglycemia is first reached, Time at which maximal glucose levels are reached, Peak Plasma Concentration (Cmax) and Area under the plasma concentration versus time curve (AUC).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 16 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.