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Type 1 DiabetesPhase 2NCT04764968

Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

A Phase 2 study testing Dasiglucagon 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 aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes. 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?
Dasiglucagon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteDenmark
Study dates
27 Apr 2021to 28 Jan 2022
Phase
Phase 2
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 years
  • T1D ≥ 2 years
  • Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) ≥ 6 months
  • Use of CGM (real-time or intermittently scanned) ≥ 3 months and ≥ 70% during the previous 14 days
  • HbA1c ≤ 70 mmol/l (8.5%)
  • Performs aerobic exercise on a regular basis (≥ 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study.
  • Use of carbohydrate counting and bolus calculator (self-reported)
  • Sensor glucose level < 3.9 mmol/l on ≥ 4/14 previous days assessed by CGM data

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
  • Known or suspected allergies to glucagon or related products
  • History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
  • Patients with pheochromocytoma or insulinoma
  • Hypoglycemia unawareness
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
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  • 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

  • Steno Diabetes Center Copenhagen

    Gentofte Municipality, 2820

Other trials in Denmark

About this study

Official title: Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes: A Randomized, Open-Label, Two-Period Crossover Outpatient Study

The aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.

Read the detailed description

A randomized, open-label, two-arm, two-week crossover study will be conducted to assess the study objectives. The study will enroll 24 participants with insulin pump-treated type 1 diabetes. Upon study enrollment, participants will complete two consecutive 2-week periods - a 'usual care' period and 'dasiglucagon' period. During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension. During the 'dasiglucagon' period, participants will use pen-administered low-dose dasiglucagon to treat or prevent episodes of hypoglycemia.

Being tested
Dasiglucagon
Keywords
Type 1 Diabetes, Hypoglycemia, Dasiglucagon
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasiglucagonDrug

    Abdominal s.c. administration using a multi-dose reusable pen injector

Study groups in NCT04764968
Study groupRoleWhat they receive
Usual careNo interventionDuring the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension.
DasiglucagonExperimentalDuring the 'dasiglucagon' period, participants will use pen-administered low-dose (80 µg) dasiglucagon to treat or prevent episodes of hypoglycemia.
Receives: Drug: Dasiglucagon

What is being measured

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

  1. Difference in percentage of time in range between the two study periods

    Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

Secondary outcomes (13)

  1. Difference in percentage of time in hypoglycemia between the two study periods

    Sensor glucose level < 3.9 mmol/l

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  2. Difference in percentage of time in hyperglycemia between the two study periods

    Sensor glucose level > 10 mmol/l

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  3. Difference in coefficient of variation (%) between the two study periods

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  4. Difference between successful cases (%) of hypoglycemia treatment between the two study periods

    Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  5. Difference in successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia [sensor glucose level > 10 mmol/l during the first two hours post-treatment] between the two study periods

    Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment AND sensor glucose level ≤ 10 mmol/l during the first two hours post-treatment

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  6. Difference in successful cases (%) of hypoglycemia prevention between the two study periods

    Initial sensor glucose level > 3.9 mmol/l AND sensor glucose level < 3.9 for ≤ 15 consecutive minutes during the first two hours post-treatment

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  7. Difference in time from hypoglycemia treatment to euglycemia between the two study periods

    Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  8. Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration

    Measured: 2-week 'dasiglucagon' period

  9. Difference between the average daily carbohydrate intake between the two study periods

    Registered on the insulin pump

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  10. Difference between the average total daily insulin dose between the two study periods

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  11. Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods

    Intensity: mild/moderate/severe

    Measured: 2-week 'usual care' period and 2-week 'dasiglucagon' period

  12. Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire

    Scoring likely OR very likely on a four-point Likert scale

    Measured: At the end-of-study visit (estimated week 6)

  13. Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies

    Measured: Measured 4 weeks after the 'dasiglucagon' period

Timeline

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

  1. First posted21 Feb 2021
  2. Study start27 Apr 2021
  3. Primary completion30 Dec 2021
  4. Study completion28 Jan 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
A Randomized, Open-Label, Two-Period, Two-Week Crossover Outpatient Study
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04764968
Sponsor's protocol ID
77119
Other IDs
H-21000002, 2020-005745-16
Status last verified
Sep 2022
First submitted
16 Feb 2021
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laugesen C, Ranjan AG, Schmidt S, Norgaard K. Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial. Diabetologia. 2023 Jul;66(7):1208-1217. doi: 10.1007/s00125-023-05909-4. Epub 2023 Apr 11.

    PubMed 37037948

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasiglucagon 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 8 inclusion and 9 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 7 Sep 2022. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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?

Difference in percentage of time in range between the two study periods (time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period). 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 NCT04764968, which also lists 1 linked publication.

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 7 Sep 2022.

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