Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia

What Was Tested

This registered phase 2 trial tested Glucagon.

It had three arms (groups): one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Healthy male or female subjects between the ages of 18 and 60 years of age, inclusive, at Screening. Women must be of non-childbearing potential as defined by one of the following:. Females who are \>45 and \< 60 years of age at Screening and amenorrheic for at least 2 years. Females who have had a documented hysterectomy and/or bilateral oophorectomy. Diaphragm with spermicide.

The full record lists 15 inclusion and 21 exclusion criteria; among the exclusions: study participants who are pregnant at screening are not eligible for this study; breast feeding must be discontinued if a subject wishes to participate in this study; positive test for hepatitis b, hepatitis c, or hiv found at screening.

How the Study Was Run

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

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.

Blinding on both sides kept the participants and researchers unaware of who received Glucagon.

Those kept unaware of assignments: participant and investigator.

It started in 2013-10 with completion listed for 2014-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Serious Adverse Events.

It also tracked 9 secondary outcomes, for example Glucose Area Under the Curve (AUC), Glucose Cmax, Glucose Tmax, Glucose AUCex, Glucose MAE and Glucose Tex.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 30 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.