Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults

What Was Tested

The trial (phase 3) is built around Glucagon.

It had two arms (groups): Nasal Glucagon (experimental) and Intramuscular Glucagon (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 77 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: At least 18.0 years of age and less than 65.0 years. Body mass index (BMI) greater than or equal to 20.0 and below or equal to 35.0 kilograms per meter squared (kg/m²). Weighs at least 50 kg (110 pounds). Females must meet one of the following criteria:. Willingness to adhere to the study requirements.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or are lactating; history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs; history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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.

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

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

It started in 2013-11 with completion listed for 2015-01.

It ran at 8 sites in United States (8).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Nasal and Non-nasal Effects/Symptoms, Recovery From Symptoms of Hypoglycemia, Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Baseline-Adjusted Glucagon, Maximum Change From Baseline Concentration (Cmax) of Glucagon, Time to Maximum Change From Baseline Concentration (Tmax) of Glucagon and Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 77 people.

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.