Assessment of Intranasal Glucagon on Endogenous Glucose Production

What Was Tested

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

In rodents hypothalamic action of glucagon paradoxically suppresses glucose production.

It had two arms (groups): Intranasal placebo (placebo comparator) and Intranasal glucagon (experimental).

Placebo comparator.

Active intervention.

The registry classes the interventions as drug.

More on the Plan

Intranasal placebo administration with measurement of endogenous glucose production under pancreatic clamp conditions.

At 7am (t=0) the next day, the researchers will begin a primed, constant intravenous infusion of \[6,6-2H2\]glucose (D2 glucose; Cambridge Isotope Laboratories, MA; a stable isotope of glucose, the enrichment of which can be measured by GC/MS, allowing them to calculate endogenous glucose production rates).

The infusion will continue for 8 hours.

At the same time (7am) a pancreatic clamp will be started for 8 hours in order to suppress pancreatic hormone secretion with somatostatin while providing basal infusions of pancreatic hormones and growth hormone by intravenous infusion.

Who Took Part

10 actual participants took part.

It was open to men only aged from 18 years up to 60 years.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: 1\. study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2015-03 with completion listed for 2016-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Endogenous glucose production following intranasal glucagon compared to placebo (time frame: 6 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 10 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.