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Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents

Plain-language guide to NCT06588504: phase 1 randomized trial of Glucagon, 38 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06588504
Phase
phase 1
Status
completed
Start
2024-09-10
Completion (planned or actual)
2025-07-20
Participants
38 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Diabetes Mellitus, Type 1
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 1 trial tested Glucagon.

This study will be looking to confirm the effect of dasiglucagon when compared with glucagon for treating very low sugar levels in Asian adults with T1D and the effect of dasiglucagon in Japanese adolescents with T1D.

Participants will get dasiglucagon and glucagon.

It had three arms (groups): Adult Cohort: Dasiglucagon then Glucagon (experimental), Adult Cohort: Glucagon then Dasiglucagon (experimental) and Adolescent Cohort: Dasiglucagon (experimental).

Participants will receive a single s.c. injection of dasiglucagon.

The registry classes the interventions as drug.

Who Took Part

The registry lists 38 actual participants took part.

It was open to people of any sex aged from 12 years up to 75 years.

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

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products (glucagon or its derivatives); exposure to an investigational medicinal product (imp) within 30 days or 5 times the half-life of the imp (if known), whichever is longest before screening; severe hypoglycaemia in the last month prior to screening.

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.

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

Being open-label, the Glucagon study did not mask who received what.

It started in 2024-09-10 with completion listed for 2025-07-20.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example PG recovery within 30 minutes after IMP injection (yes/no), PG recovery within 20 minutes after IMP injection (yes/no), PG recovery within 15 minutes after IMP injection (yes/no), PG change from baseline at 15 minutes after IMP injection, PG change from baseline at 20 minutes after IMP injection and Area under the plasma dasiglucagon concentration time curve after IMP injection.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 38 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Glucagon: A 29-amino-acid pancreatic hormone that raises blood glucose; used as a rescue medicine for severe low blood sugar and as a diagnostic aid.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.