Evaluate the Immunogenicity of a Novel Glucagon Formulation

What Was Tested

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

This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.

It had two arms (groups): Glucagon IM (active comparator) and Nasal Glucagon (NG (experimental).

The registry classes the interventions as drug.

More on the Plan

This study is a single center, randomized, laboratory-blinded, three periods, parallel design study.

The secondary objective is to evaluate the safety and tolerability of glucagon following NG and IM administration in adults with T1D or T2D.

Each drug administration was separated by at least seven calendar days.

Patients were randomized in a 2:1 ratio (NG:IMG) to receive NG or IMG at each of the 3 periods.

Who Took Part

75 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Availability for the entire study period. Male or female patient with a history of Type 1 or Type 2 diabetes of at least 2 years duration. A female volunteer must meet one of the following criteria:. Abstinence from heterosexual intercourse. Systemic contraceptives (birth control pills, injectable/implant /insertable hormonal birth control products, transdermal patch).

The full record lists 15 inclusion and 19 exclusion criteria; among the exclusions: females who are pregnant, actively attempting to get pregnant, or are lactating; suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases; known presence of rare hereditary problems of galactose and /or lactose intolerance.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

The Glucagon group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Glucagon study: the participants and staff both knew the treatment.

It started in 2013-09 with completion listed for 2013-12.

It ran at 1 site in Canada.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Treatment-emergent Anti-Drug Antibody (ADA) (time frame: Baseline through study completion (up to 10 weeks)). Percentage of Participants With Neutralizing Antibodies (time frame: Baseline through study completion (up to 10 weeks)). Number of Participants With At Least One Adverse Event.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 75 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.