Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

What Was Tested

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

It had two arms (groups): Dasiglucagon (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Randomization also determined whether the subject was to be injected in the buttock or deltoid.

A rescue glucose infusion could be administered to ameliorate persistent hypoglycemia.

Who Took Part

The registry lists 45 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: Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3). Aged between 18 and 75 years, both inclusive.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program; known or suspected allergy to trial drug(s) or related products; history of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Glucagon, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-11-01 with completion listed for 2019-03-11.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to Plasma Glucose Recovery.

It also tracked 11 secondary outcomes, for example Plasma Glucose Recovery After Trial Drug Injection, Plasma Glucose Changes From Baseline, Time to Target Plasma Glucose Concentration, Immunogenicity - Occurrence of Anti-drug Antibodies, Rescue Infusions of IV Glucose After Trial Drug Administration and Time to First Rescue Infusion of IV Glucose After Trial Drug Administration.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 45 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.