Efficacy of Small Subcutaneous Glucagon Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Glucagon.

In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection.

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug and procedure.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Males and females ≥ 18 years of old. Clinical diagnosis of type 1 diabetes for at least two years.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: severe hypoglycemic episode within two weeks of screening; pheochromocytoma or primary adrenal insufficiency (e.g. addison's disease); medical condition likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

As a double-blind Glucagon study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2013-04 with completion listed for 2013-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incremental area under the curve of plasma glucose concentrations (time frame: 30 minutes).

It also tracked 6 secondary outcomes, for example Time-to-peak plasma glucagon concentration.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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