Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Between the ages of 18 and 50 years of age, inclusive, at Screening. Male subjects are required to use a condom and another of the methods of contraception in #3 above starting at Randomization and for the duration of the study. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.

The full record lists 7 inclusion and 20 exclusion criteria; among the exclusions: clinical evidence of microvascular complication(s) other than mild microalbuminuria or history of mild non-proliferative retinopathy; blood pressure (bp) readings at screening where systemic bp \<90 or \>140 mm hg, and diastolic bp \<50 or \>90 mm hg; study participants who are pregnant at screening.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

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.

In this single-blind Glucagon study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2014-03 with completion listed for 2014-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Serious Adverse Events.

It also tracked 12 secondary outcomes, for example Glucagon Cmax (Fasting), Glucagon Cmax (Post-insulin), Glucagon Area Under the Curve (AUC) (Fasting), Glucagon AUC (Post-insulin), Glucagon Tmax (Fasting) and Glucagon Tmax (Post-insulin).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 13 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.