A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System

What Was Tested

In this phase 2 trial, researchers set out to test Glucagon.

The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1.

This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects.

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

The registry classes the interventions as drug.

More on the Plan

(Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1.

Study design: This study is a single-center, double-blinded, randomized, cross over trial which will be performed out-patient.

Study population: The study population will comprise 12 subjects with diabetes type 1 using the AP system.

The subject will be randomized to receive either dasiglucagon or GlucaGen® during the first three days.

Who 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: Diagnosed with diabetes mellitus type 1;. Age between 18 and 75 years;. Adequate contraception is required (only applicable for female participants);. Willing and able to sign informed consent. Treated with SAP or CSII for a minimum of 6 months;.

The full record lists 9 inclusion and 8 exclusion criteria; among the exclusions: impaired awareness of hypoglycemia (score ≥ 4) according to gold and/or clarke questionnaire \[3\], \[4\];; pregnancy and/or breastfeeding;; severe liver/heart/renal failure;.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Glucagon.

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

It started in 2023-12-29 with completion listed for 2023-12-29.

It ran at 1 site in Netherlands.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Time in range (time frame: 3 days).

It also tracked 9 secondary outcomes, for example Side effects, Extra food intakes (food intake diary) and AP related parameters - algorithm.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.