G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes

What Was Tested

The trial (phase 3) is built around Glucagon.

Each daytime visit is preceded by an overnight stay in the CRC.

It had two arms (groups): one (other) and one (other).

The registry classes the interventions as drug.

Who Took Part

The registry lists 81 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Males and females diagnosed with type 1 diabetes mellitus for at least 24 months. Current usage of daily insulin treatment that includes having an assigned "correction factor" for managing hyperglycemia. Age 18-75 years, inclusive. Random serum C-peptide concentration \< 0.5 ng/mL. Willingness to follow all study procedures, including attending all clinic visits.

The full record lists 6 inclusion and 28 exclusion criteria; among the exclusions: BMI \> 40 kg/m2; serum alt or ast equal to or greater than 3 times the upper limit of normal; BP readings at Screening where SBP \<90 or \>150 mm Hg, and DBP \<50 or \>100 mm Hg.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant.

It started in 2018-01-23 with completion listed for 2018-04-18.

It ran at 6 sites in United States (4) and Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Subjects With a Positive Glucose Response.

It also tracked 13 secondary outcomes, for example Time for Positive Glucose Response, Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms, Number of Subjects With Relief of Neuroglycopenic Symptoms, Time to Resolution of Autonomic Symptoms, Time to Resolution of Neuroglycopenic Symptoms and Time to Resolution of the Feeling of Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 81 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.