A Phase 4 interventional study of Low-Dose Glucagon and Glucose Arm in Type 1 Diabetes Mellitus, sponsored by Steno Diabetes Center Copenhagen. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Steno Diabetes Center Copenhagen · Phase 4, Interventional, and Prevention
The objective of the study is to evaluate whether pre-exercise administration of low-dose subcutaneous glucagon prevents or attenuates exercise-induced declines in plasma glucose concentration during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes after a meal in adults with type 1 diabetes using an automated insulin delivery (AID) system.
The primary endpoint is the difference in the change in plasma glucose (PG) from exercise initiation to the nadir during exercise and through the 2-hour post-exercise period between the glucagon (GCN) and carbohydrate (CHO) visits.
This is a randomized, non-blinded, two-period crossover study including 18 adults with type 1 diabetes using an EU-approved automated insulin delivery (AID) system. Each participant will attend one screening visit followed by two experimental visits performed in random order, separated by at least seven days.
Eligible participants are adults (≥18 years) with type 1 diabetes for at least 2 years, using an automated insulin delivery system for ≥3 months, treated with NovoRapid or Fiasp for at least 1 week prior to enrollment, and proficient in carbohydrate counting.
At each experimental visit, participants will perform a standardized bout of MICE approximately 90 minutes after a meal. On one visit, a low-dose glucagon injection will be administered immediately before exercise; on the other, 20 g oral glucose tablets will be consumed. Right before exercise, the AID system's higher glucose target/exercise mode will be activated and will remain active until 15 minutes after exercise.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 18 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Steno Diabetes Center Copenhagen is the lead sponsor of 113 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Plasma and sensor glucose are monitored before, during, and after a bout of moderate-intensity exercise shortly after consumption of a meal. Before exercise initiation, participants will be given low-dose glucagon to prevent hypoglycemia.
Drug: Low-Dose Glucagon
Plasma and sensor glucose are monitored before, during, and after a bout of moderate-intensity exercise shortly after consumption of a meal. Before exercise initiation, participants will be given a dose of glucose to prevent hypoglycemia.
Dietary Supplement: Glucose Arm
Participants will be given a low-dose of glucagon before starting the exercise session
Participants will be given a dose of glucose before starting exercise
Change in plasma glucose (PG) from exercise initiation to the nadir during exercise and throughout the 2-hour post-exercise period between visit GCN and CHO
Time frame: From exercise initiation until two hours following exercise
Percent PG time in range (3.9-10.0 mmol/L) between visits GCN and CHO
Time frame: From exercise onset to +120 min
Incidence of hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO
Binary
Time frame: 0-180 min
Time to hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO
Time frame: 0-180 min
Percent time below range (PG <3.9 mmol/L) between visit GCN and CHO
Time frame: 0-180 mins
Percent time above range (PG >10.0 mmol/L) between visits GCN and CHO
Continuous
Time frame: 0-180 min
Incidence of hyperglycemia (PG >10.0 mmol/L) between visits GCN and CHO
Binary
Time frame: 0-180 mins
Nadir PG concentration between visits GCN and CHO
Continuous
Time frame: 0-180 mins
Peak PG concentration between visits GCN and CHO
Continuous
Time frame: 0-180 mins
Incremental peak PG concentration between visits GCN and CHO
Continuous
Time frame: 0-180 mins
Mean PG concentration between visits GCN and CHO
Continuous
Time frame: 0-180 mins
PG area under the curve (AUC) between visits GCN and CHO
Continuous
Time frame: 0-180 mins
Standard deviation of PG between visits GCN and CHO
Continuous
Time frame: 0-180 mins
Coefficient of variation of PG between visits GCN and CHO
Continuous
Time frame: 0-180 mins
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Of 62 non-industry phase 4 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 74 studies reached it within 22 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Glucagon · Glucose
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