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Type 1 DiabetesNCT05076292

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

A study testing GlucaGen and Saline in people with Type 1 Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes, Hypoglycemia
What is being tested?
GlucaGen and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteDenmark
Study dates
23 Nov 2021to 8 Aug 2023
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Sissel Banner Lundemose

    Gentofte Municipality, 2820

Other trials in Denmark

About this study

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.

Being tested
GlucaGen, Saline
Keywords
Type 1 Diabetes, Exercise, Hypoglycemia, Glucagon, Continuous Glucose Monitoring
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.

  • GlucaGenDrug

    Also called Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01

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

  • SalineDrug

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

    Saline will be used as placebo before and after exercise.

Study groups in NCT05076292
Study groupRoleWhat they receive
150 ug glucagon before exerciseExperimental150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise.
Receives: Drug: GlucaGen
2*75 ug glucagon before exercise and after exerciseExperimental75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise.
Receives: Drug: GlucaGen
Saline as placeboActive comparatorSaline as placebo will be administered in the same amount as glucagon before and after exercise.
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From 0-180 minutes post-intervention

Secondary outcomes (17)

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

    Measured: From 0-180 minutes post-intervention

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

    Measured: From 0-180 minutes post-intervention

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

    Measured: From 0-180 minutes post-intervention

  4. Change in plasma glucose levels

    Measured: From 0-180 minutes post-intervention

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

    Measured: From 0-180 minutes post-intervention

  6. Nadir plasma glucose concentration

    Measured: From 0-180 minutes post-intervention

  7. Peak plasma glucose concentration

    Measured: From 0-180 minutes post-intervention

  8. Incremental peak in plasma glucose concentration

    Measured: From 0-180 minutes post-intervention

  9. Mean plasma glucose concentration

    Measured: From 0-180 minutes post-intervention

  10. Plasma glucose Area Under the Curve (AUC)

    Measured: From 0 to 180 min post-intervention

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

    Measured: 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

    Measured: From 0-180 minutes post-intervention

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

    Measured: During exercise

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

    Measured: During the three-day outpatient period

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

    Measured: During exercise

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

    Measured: 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)

    Measured: During exercise and during the three-day outpatient period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start23 Nov 2021
  3. Primary completion8 Aug 2023
  4. Study completion8 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
A randomized, single-blinded, placebo-controlled three-arm cross-over study
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05076292
Sponsor's protocol ID
78618
Other IDs
2021-001342-34
Status last verified
Dec 2023
First submitted
29 Sep 2021
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GlucaGen and Saline in people with Type 1 Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence rate of hypoglycemia (PG < 3.9 mmol/l) (time frame: From 0-180 minutes post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05076292.

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 5 Dec 2023.

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