Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia

What Was Tested

This registered phase 2 trial tested Glucagon.

It had four arms (groups): one (experimental), one (experimental), SC Glucagon (active comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The participants were assigned at random to a group that received one treatment for each of the 3 study periods.

The glucagon administrations were separated by approximately 7 calendar days.

Who Took Part

The registry lists 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: History of type 1 diabetes between 2 and 30 years. Receiving daily insulin injections or insulin pump therapy for at least 2 years. Body mass index (BMI) greater than or equal to 20.00 and below or equal to 33.00 kg/m2.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: score ≥4 on the clarke hypoglycemia awareness survey at screening; presence or history of pheochromocytoma (i.e. adrenal gland tumor); known presence of hereditary problems of galactose and /or lactose intolerance.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

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

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-03 with completion listed for 2012-07.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Responders. Number of Participants With at Least One Adverse Event (time frame: Within 3 hours post glucagon administration).

It also tracked 5 secondary outcomes, for example Maximum Concentration (Cmax) of Baseline-Adjusted Glucose, Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose, Maximum Change From Baseline Concentration (Cmax) of Glucagon, Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon and Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 18 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.