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CompletedNCT05076292Updated Dec 5, 2023

Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

An interventional study of GlucaGen and Saline in Type 1 Diabetes and Hypoglycemia, sponsored by Steno Diabetes Center Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).

The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.

Read the detailed description

A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo.

During the visits and in an outpatient period the participants will have 3 different CGM devices installed and the values will be compared with self-monitored blood glucose values.

02

Conditions studied

  • Type 1 Diabetes
  • Hypoglycemia

Keywords

  • Type 1 Diabetes
  • Exercise
  • Hypoglycemia
  • Glucagon
  • Continuous Glucose Monitoring
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Steno Diabetes Center Copenhagen is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18
  • T1D ≥ 2 years
  • Use of insulin pump or MDI therapy for ≥ 6 months
  • Current use of insulin aspart
  • HbA1c ≤ 70mmol/mol (8.5%)
  • Body mass index (BMI) ≤ 30 kg/m2
  • Performs exercise ≥1 time per week

Exclusion criteria

Exclusion Criteria:

  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
  • Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)
  • Known or suspected allergies to glucagon or related products
  • History of hypersensitivity or allergic reaction to glucagon or lactose
  • Allergy to the patch of the CGM devices
  • Patients with pheochromocytoma, insulinoma or gastroparesis
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
  • Inability to understand the individual information and to give informed consent
  • Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
  • Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    150 ug glucagon before exercise

    150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise.

    Drug: GlucaGen

  • Experimental
    2*75 ug glucagon before exercise and after exercise

    75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise.

    Drug: GlucaGen

  • Active comparator
    Saline as placebo

    Saline as placebo will be administered in the same amount as glucagon before and after exercise.

    Drug: Saline

Interventions

  • DrugGlucaGen

    150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.

    Also known as: Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01

  • DrugSaline

    Saline will be used as placebo before and after exercise.

    Also known as: ATC-code: Natriumklorid isotonisk "BAUER" B05BB01, V07AB

06

What researchers measure

Primary outcomes

  1. Incidence rate of hypoglycemia (PG < 3.9 mmol/l)

    Time frame: From 0-180 minutes post-intervention

Secondary outcomes

  1. Percentage of time below range (PG < 3.9)

    Time frame: From 0-180 minutes post-intervention

  2. Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l)

    Time frame: From 0-180 minutes post-intervention

  3. Time (min) to hypoglycemia (PG < 3.9 mmol/l)

    Time frame: From 0-180 minutes post-intervention

  4. Change in plasma glucose levels

    Time frame: From 0-180 minutes post-intervention

  5. Incidence rate of hyperglycemia (PG > 10 mmol/l)

    Time frame: From 0-180 minutes post-intervention

  6. Nadir plasma glucose concentration

    Time frame: From 0-180 minutes post-intervention

  7. Peak plasma glucose concentration

    Time frame: From 0-180 minutes post-intervention

  8. Incremental peak in plasma glucose concentration

    Time frame: From 0-180 minutes post-intervention

  9. Mean plasma glucose concentration

    Time frame: From 0-180 minutes post-intervention

  10. Plasma glucose Area Under the Curve (AUC)

    Time frame: From 0 to 180 min post-intervention

  11. Percentage of time in hyperglycemia (PG > 10 mmol/l)

    Time frame: From 0-180 minutes post-intervention

  12. Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention

    Time frame: From 0-180 minutes post-intervention

  13. Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value)

    Time frame: During exercise

  14. MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value)

    Time frame: During the three-day outpatient period

  15. MARD during the three-hour inpatient study visit (using YSI as reference value)

    Time frame: During exercise

  16. Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value)

    Time frame: During exercise and during the three-day outpatient period

  17. Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value)

    Time frame: During exercise and during the three-day outpatient period

07

Study locations

1 site
  • Sissel Banner Lundemose
    Gentofte, 2820, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05076292
Lead sponsor
Steno Diabetes Center Copenhagen
Responsible party
Sponsor
First posted
Oct 13, 2021
Start date
Nov 23, 2021
Primary completion
Aug 8, 2023
Completion
Aug 8, 2023
Last update
Dec 5, 2023

Study contacts

Sissel B Lundemose, MD
principal investigator · Steno Diabetes Center Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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