Type 1 DiabetesEarly Phase 1NCT04192019
Micro Glucagon During Exercise in Type 1 Diabetes
A Early Phase 1 study testing Micro-glucagon and Mini-glucagon in people with Type 1 Diabetes and Hypoglycemia, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Micro-glucagon and Mini-glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Subcutaneous Dasiglucagon Use During Exercise In People With Type 1 Diabetes: Effects On Plasma Glucose And Exercise Metabolism
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.
Read the detailed description
People with type 1 diabetes (T1D) are recommended to engage in regular exercise for a variety of health and fitness reasons. However, moderate-intensity exercise is associated with an increased risk of hypoglycaemia in people with T1D. Current guidelines are to reduce insulin dose and/or increase carbohydrate consumption in the context of the exercise bout. However, despite the many advances in insulin formulations and delivery devices, hypoglycaemia remains a significant risk. Mini-dose glucagon taken before an exercise bout has been shown to be an effective non-caloric strategy to prevent exercise-induced hypoglycaemia. However, even the reduced doses (150-200 µg) used in previous studies might still be rather high translating into potential side-effects (i.e. hyperglycaemia, gastrointestinal symptoms, etc.). Lower doses (below 100 µg, micro-glucagon) may be sufficiently effective to counteract hypoglycaemia risk associated with exercise and associated with better tolerance. Moreover, there is little information on the effects of subcutaneous glucagon on glycogen stores and changes in exercise metabolism. Greater understanding of exercise-associated metabolism following mini- and micro-dose glucagon using techniques such as magnetic resonance spectroscopy (MRS), continuous glucose monitoring (CGM), stable isotope tracers, and indirect calorimetry may result in novel approaches to improve blood glucose management in people with T1D. Utilising these techniques may also further our understanding of the optimal glucagon dosing (timing and amount) during exercise to manage hypoglycaemia and reduce the risk of adverse events. 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. Secondly, to investigate exercise-metabolism following Dasiglucagon injection using 3 tesla magnetic resonance spectroscopy (MRS) and indirect calorimetry. Third, to assess participant experience of Dasiglucagon during exercise and the incidence of adverse events.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Micro-glucagon, Mini-glucagon
- Keywords
- type 1 diabetes, glucagon, hypoglycemia, exercise, glycogen
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-glucagonDrug
Also called Dasiglucagon
Administration of 80 µg (micro-dose) subcutaneous Dasiglucagon 5 min before the start of exercise
Mini-glucagonDrug
Also called Dasiglucagon
Administration of 150 µg (mini-dose) subcutaneous Dasiglucagon 5 min before the start of exercise
| Study group | Role | What they receive |
|---|---|---|
| Micro-dose glucagon | Experimental | 80 µg (micro-dose) subcutaneous Dasiglucagon 5 min before the start of exercise Receives: Drug: Micro-glucagon |
| Mini-dose glucagon | Experimental | 150 µg mini-dose of subcutaneous Dasiglucagon 5 min before exercise the start of exercise Receives: Drug: Mini-glucagon |
| No treatment | No intervention | No treatment before the start of exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hypoglycaemia
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
Measured: 60 minutes
Secondary outcomes (8)
Change in glycaemia during exercise
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
Measured: 60 minutes
Glucose during exercise
Mean glucose concentration and area under the glucose curve during exercise
Measured: 60 minutes
Glucagon during exercise
Mean glucagon concentration and area under the glucagon curve during exercise
Measured: 60 minutes
Time in target
Time in target glycaemic range (4-10 mmol/L) in the recovery period and overnight
Measured: 24 hours
Time in target during exercise
Time in target glycaemic range (4-10 mmol/L) during exercise
Measured: 60 minutes
Hypoglycaemia
Incidence of hypoglycaemia (≤3.9 mmol/L for 15 min or more) during the 24 hour post exercise recovery period
Measured: 24 hours
Glycogen content
Change in skeletal muscle and hepatic glycogen following exercise
Measured: 4 hours
Any adverse events
Adverse symptoms following glucagon/placebo use
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study startApr 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: Prioritization of other projects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Time to hypoglycaemia during 60 minutes of aerobic exercise in individuals with type 1 diabetes using mini and micro doses of Dasiglucagon compared to no Dasiglucagon
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Stettler, MD, Principal investigator, Clinic Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192019
- Sponsor's protocol ID
- GLU-01
- Status last verified
- Aug 2023
- First submitted
- 6 Dec 2019
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Dasiglucagon Use During Exercise In People With Type 1 Diabetes: Effects On Plasma Glucose And Exercise Metabolism
- ClinicalTrials.gov ID
- NCT04192019
- Acronym / sponsor ID
- GLU-01
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- type 1 diabetes, glucagon, hypoglycemia, exercise, glycogen
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Prioritization of other projects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
People with type 1 diabetes (T1D) are recommended to engage in regular exercise for a variety of health and fitness reasons. However, moderate-intensity exercise is associated with an increased risk of hypoglycaemia in people with T1D. Current guidelines are to reduce insulin dose and/or increase carbohydrate consumption in the context of the exercise bout. However, despite the many advances in insulin formulations and delivery devices, hypoglycaemia remains a significant risk. Mini-dose glucagon taken before an exercise bout has been shown to be an effective non-caloric strategy to prevent exercise-induced hypoglycaemia. However, even the reduced doses (150-200 µg) used in previous studies might still be rather high translating into potential side-effects (i.e. hyperglycaemia, gastrointestinal symptoms, etc.). Lower doses (below 100 µg, micro-glucagon) may be sufficiently effective to counteract hypoglycaemia risk associated with exercise and associated with better tolerance. Moreover, there is little information on the effects of subcutaneous glucagon on glycogen stores and changes in exercise metabolism. Greater understanding of exercise-associated metabolism following mini- and micro-dose glucagon using techniques such as magnetic resonance spectroscopy (MRS), continuous glucose monitoring (CGM), stable isotope tracers, and indirect calorimetry may result in novel approaches to improve blood glucose management in people with T1D. Utilising these techniques may also further our understanding of the optimal glucagon dosing (timing and amount) during exercise to manage hypoglycaemia and reduce the risk of adverse events. 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. Secondly, to investigate exercise-metabolism following Dasiglucagon injection using 3 tesla magnetic resonance spectroscopy (MRS) and indirect calorimetry. Third, to assess participant experience of Dasiglucagon during exercise and the incidence of adverse events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Time to hypoglycaemia during 60 minutes of aerobic exercise in individuals with type 1 diabetes using mini and micro doses of Dasiglucagon compared to no Dasiglucagon
| Arm | Type | Receives |
|---|---|---|
| Micro-dose glucagon | Experimental | Drug: Micro-glucagon80 µg (micro-dose) subcutaneous Dasiglucagon 5 min before the start of exercise |
| Mini-dose glucagon | Experimental | Drug: Mini-glucagon150 µg mini-dose of subcutaneous Dasiglucagon 5 min before exercise the start of exercise |
| No treatment | No intervention | –No treatment before the start of exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-glucagonAlso: DasiglucagonAdministration of 80 µg (micro-dose) subcutaneous Dasiglucagon 5 min before the start of exercise | Drug | Micro-dose glucagon |
| Mini-glucagonAlso: DasiglucagonAdministration of 150 µg (mini-dose) subcutaneous Dasiglucagon 5 min before the start of exercise | Drug | Mini-dose glucagon |
Primary outcome
Time to hypoglycaemia
Time frame: 60 minutes
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
8 secondary outcomes
Change in glycaemia during exercise
Time frame: 60 minutes
Glucose during exercise
Time frame: 60 minutes
Glucagon during exercise
Time frame: 60 minutes
Time in target
Time frame: 24 hours
Time in target during exercise
Time frame: 60 minutes
Hypoglycaemia
Time frame: 24 hours
Glycogen content
Time frame: 4 hours
Any adverse events
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Stettler, MD principal investigator
Clinic Director
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Micro-glucagon and Mini-glucagon in people with Type 1 Diabetes and Hypoglycemia, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hypoglycaemia (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.