Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

What Was Tested

The trial (phase 3) is built around Glucagon.

Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study.

The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia.

The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.

It had 1 arm (groups): Nasal glucagon (experimental).

The registry classes the interventions as drug.

More on the Plan

This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.

The study will also generate data on the participants' assessment of local tolerability and provide information on immunogenicity of nasal glucagon with regards to the potential development of anti-glucagon antibodies.

Who Took Part

129 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: With a history of type 1 diabetes \>1 year. At least 18 years of age but not older than 75 years. Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2. PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis). For female subjects, a urine pregnancy test must be negative.

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma; use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.

How the Study Was Run

The set-up was single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-05 with completion listed for 2015-08.

It ran at 9 sites in Canada (6) and United States (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver and Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Glucagon in 129 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.