Micro Glucagon During Exercise in Type 1 Diabetes

NCTNCT04192019Other idGLU-01

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: Prioritization of other projects

Overview

Status: Withdrawn
Phase: Early phase 1
Enrollment: 0 participants (actual)
Sponsor: Insel Gruppe AG, University Hospital Bern · Other
Design: Randomized · Single masking
Countries: Not stated
Start: Apr 2023 (estimated)
Primary completion: Apr 2024 (estimated)
Completion: Jun 2024 (estimated)
First posted: 10 Dec 2019
Last update posted: 1 Sept 2023
Conditions: Type 1 Diabetes · Hypoglycemia

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph Early 1
Micro Glucagon During Exercise in Type 1 Diabetes
NCT04192019
est. Apr 2023 to est. Jun 2024
Withdrawn
Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This proof-of-principle study to assess effects of different doses (mini and micro) of subcutaneous glucagon analog Dasiglucagon (Zealand Pharma, Copenhagen, Denmark) on the change in blood glucose concentration during moderate-intensity exercise in people with T1D.

Interventions

Micro-glucagonDrug
Mini-glucagonDrug

Arms3

Experimental
Micro-dose glucagon
80 µg (micro-dose) subcutaneous Dasiglucagon 5 min before the start of exercise
Experimental
Mini-dose glucagon
150 µg mini-dose of subcutaneous Dasiglucagon 5 min before exercise the start of exercise
No intervention
No treatment
No treatment before the start of exercise

Primary outcomes1

Outcomes the sponsor listed as primary.

Time to hypoglycaemia
Time frame · 60 minutes
Registry description
Time (in minutes) to hypoglycaemia (plasma glucose \<3.9mmol/l) during 60 minutes of aerobic exercise in individuals with type 1 diabetes using mini and micro doses of Dasiglucagon compared to no Dasiglucagon

Secondary outcomes(8)

Change in glycaemia during exercise
Time frame · 60 minutes
Registry description
Change in blood glucose concentration, calculated based on the participants' glucose at the start of exercise and the last value measured at the end of exercise. If the exercise is stopped early because of hypoglycaemia, the last exercise glucose value will be used for analysis
Glucose during exercise
Time frame · 60 minutes
Registry description
Mean glucose concentration and area under the glucose curve during exercise
Glucagon during exercise
Time frame · 60 minutes
Registry description
Mean glucagon concentration and area under the glucagon curve during exercise
Time in target
Time frame · 24 hours
Registry description
Time in target glycaemic range (4-10 mmol/L) in the recovery period and overnight
Time in target during exercise
Time frame · 60 minutes
Registry description
Time in target glycaemic range (4-10 mmol/L) during exercise
Hypoglycaemia
Time frame · 24 hours
Registry description
Incidence of hypoglycaemia (≤3.9 mmol/L for 15 min or more) during the 24 hour post exercise recovery period
Glycogen content
Time frame · 4 hours
Registry description
Change in skeletal muscle and hepatic glycogen following exercise
Any adverse events
Time frame · 24 hours
Registry description
Adverse symptoms following glucagon/placebo use

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * T1D for \>1 year * Male aged 18-45 years old * HbA1c \<8.0% (64 mmol/mol) based on analysis from the central laboratory unit of Bern University Hospital * Regular physical activity (defined as meeting 150 min moderate-intensity exercise per week) * Using either continuous subcutaneous insulin infusion or multiple daily injections * Written informed consent Exclusion Criteria: * Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the results as judged by the investigator * Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, SGLT2 inhibitors, GLP1 agonists * Relevant diabetic complications as judged by the investigator * Body mass index 30 kg/m2 * Uncontrolled hypertension (\>180/100 mmHg)

PepBank is a research reference. Talk to a doctor before you use any peptide.