A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus

What Was Tested

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

The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).

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

The registry classes the interventions as drug.

Who Took Part

70 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: Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs; have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma; occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study).

How the Study Was Run

Design: randomized, crossover and open-label.

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.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-11-10 with completion listed for 2017-12-17.

It ran at 2 sites in Germany (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia.

It also tracked 5 secondary outcomes, for example PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose, PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon and PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 70 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.