Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon

What Was Tested

The trial (phase 2, phase 3) is built around Glucagon.

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

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 21 years up to 80 years.

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

Examples of who could join: Age 21 to 80 years old with type 1 diabetes for at least one year. Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: unable to provide informed consent; unable to comply with study procedures; pregnancy (positive urine hcg), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

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 2014-04 with completion listed for 2018-08-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Tmax.

It also tracked 8 secondary outcomes, for example AOCGIR, GIRmin, t½Max, Injection Pain, Injection Site Erythema and Maximal Nausea.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Glucagon in 20 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.