G-Pen™ for Hypoglycemia Rescue in T1D Patients

What Was Tested

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

This is an open-label, exploratory pilot study in patients with T1D.

The study will involve two daytime clinical research center visits 7-14 days apart.

Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.

It had 1 arm (groups): Glucagon (experimental).

The registry classes the interventions as drug.

More on the Plan

Both episodes will be treated with a single subcutaneous injection of G-Pen™ glucagon.

Who Took Part

Enrollment: 7 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Type 1 diabetes mellitus for at least 24 months.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: pregnant or lactating; inadequate bilateral venous access in both arms; renal insufficiency.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Glucagon study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-04 with completion listed for 2015-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Subjects With Plasma Glucose > [amount hidden]/dL at 30 Minutes Post-treatment.

It also tracked 2 secondary outcomes, for example Time to Resolution of Induced Hypoglycemia Symptoms.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Glucagon in 7 people.

Its size is small, so on its own it can only give an early look.

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.