G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes

What Was Tested

The trial (phase 3) is built around Glucagon.

Each daytime visit is preceded by an overnight stay in the CRC.

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

The registry classes the interventions as drug.

Who Took Part

132 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: Males and non-pregnant females diagnosed with type 1 diabetes (T1D) for at least 24 months. Current usage of daily insulin treatment that includes having an assigned "correction factor" for managing hyperglycemia. Age 18 to 75 years, inclusive. Random serum C-peptide concentration \< 0.6 ng/mL. Willingness to follow all study procedures, including attending all clinic visits.

The full record lists 6 inclusion and 27 exclusion criteria; among the exclusions: body mass index (bmi) \> 40 kg/m2; serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) equal to or greater than 3 times the upper limit of normal; inadequate venous access.

How the Study Was Run

Design: randomized, crossover and single-blind.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2018-09-27 with completion listed for 2019-03-29.

It ran at 7 sites in United States (4), Canada (2) and Austria (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Severe Hypoglycemia Rescue (time frame: At 30 minutes following administration of study drug).

It also tracked 4 secondary outcomes, for example Plasma Glucose Response 1, Plasma Glucose Response 2, Administration Time and Hypoglycemia Resolution.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 132 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.