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Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
Plain-language guide to NCT05960565: phase 2 randomized trial of Glucagon, 9 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05960565
- Phase
- phase 2
- Status
- terminated early
- Start
- 2023-12-22
- Completion (planned or actual)
- 2023-12-22
- Participants
- 9 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 1 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Glucagon.
The investigators will study the effect of microdoses of glucagon at the site of subcutaneous insulin injection.
The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.
It had two arms (groups): Glucagon (experimental) and Control (no intervention).
Insulin injected without any glucagon.
The registry classes the interventions as drug.
More on the Plan
People with type 1 diabetes will come fasting in the morning to the research facility on two separate days.
Frequently collected blood sampled will be analysed for glucose, insulin and glucagon for 3.5 hours.
Who Took Part
The registry lists 9 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.
The full record lists 0 inclusion and 5 exclusion criteria; among the exclusions: pregnant women or women trying to conceive; any chronic disease, including psychiatric illness, judged incompatible with participation in the study; unfit for participation for any reason judged by the investigators.
How the Study Was Run
Design: randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.
Each person switched between Glucagon and the comparison at some point, usually with a gap in between.
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.
It started in 2023-12-22 with completion listed for 2023-12-22.
It ran at 1 site in Norway.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Area under the glucose curve (time frame: From time 0 minutes to time 60 minutes).
It also tracked 5 secondary outcomes, for example Area under glucose curve, Area under insulin curve and Area under glucagon curve.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Glucagon in 9 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); 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.