Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics

What Was Tested

In this phase 3 trial, researchers set out to test Glucagon.

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

The registry classes the interventions as drug.

More on the Plan

Patients will complete screening procedures up to 60 days before randomization to determine eligibility before enrollment to the treatment phase.

There will be wash out period of 7-28 days between treatment visits.

Who Took Part

80 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: Diagnosed with type 1 diabetes mellitus for at least 24 months. Usage of daily insulin treatment. Random serum C-peptide concentration \< 0.5 ng/mL.

The full record lists 3 inclusion and 22 exclusion criteria; among the exclusions: pregnant or nursing; renal insufficiency; hepatic synthetic insufficiency.

How the Study Was Run

Design: randomized, crossover and triple-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.

As a double-blind Glucagon study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2017-03-15 with completion listed for 2017-08-14.

It ran at 7 sites in United States (6) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hypoglycemia Rescue: Intent-to-Treat Population (time frame: At 30 minutes following administration of study drug). Hypoglycemia Rescue: Per Protocol Population (time frame: At 30 minutes following administration of study drug). Hypoglycemia Rescue: Alternate Glucose Response Definition (time frame: At 30 minutes following administration of study drug).

It also tracked 6 secondary outcomes, for example Plasma Glucose Area Under the Curve (AUC), Plasma Glucose Maximum Concentration (Cmax), Plasma Glucose Time to Maximum Concentration (Tmax), Time to Resolution of Hypoglycemia Symptoms and Global Assessment of Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 80 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.