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Trial · Interventional

CompletedPhase 2Registry data

Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes

NCTNCT04449692 (opens ClinicalTrials.gov in a new tab)Other idH-20013256Other id2020-000551-12Other idH-20013256
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Overview

Status
Completed
Phase
Phase 2
Enrollment
20 participants (actual)
Sponsor
Steno Diabetes Center Copenhagen · Other
Design
Randomized · Single masking
Countries
1 country

Denmark

Start
2 Jul 2020
Primary completion
4 Jan 2021
Completion
4 Jan 2021
First posted
29 Jun 2020
Last update posted
9 Feb 2021
Conditions
Type 1 Diabetes · Hypoglycemia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 2

    Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes

    NCT04449692

    2 Jul 2020 to 4 Jan 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma, Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes.

Interventions

  • DasiglucagonDrug
  • Carbohydrate (dextrose tablets)Other

Arms3

  • Experimental

    80 µg s.c. dasiglucagon

    80 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l

  • Experimental

    120 µg s.c. dasiglucagon

    120 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l

  • Active comparator

    15 g oral carbohydrate (dextrose tablets)

    15 g of oral carbohydrate (dextrose tablets) will be administered when plasma glucose levels reach 4.5 mmol/l

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Difference between study visits in time (min) in hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

Secondary outcomes(20)

  1. Difference between study visits in incidence rate of hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  2. Difference between study visits in incidence rate of level 2 hypoglycemia (plasma glucose < 3.0 mmol/l) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  3. Difference between study visits in incidence rate of rebound hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  4. Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  5. Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  6. Difference between study visits in incremental peak in plasma glucose concentration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  7. Difference between study visits in mean plasma glucose concentration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  8. Difference between study visits in time (min) from intervention to first increase in plasma glucose concentration of 1.1 mmol/l

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  9. Difference between study visits in plasma glucose Area Under the Curve (AUC) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  10. Difference between study visits in time (min) to peak plasma glucose concentration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  11. Difference between study visits in time (min) in range (plasma glucose ≥ 3.9 mmol/l and 10.0 mmol/l) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  12. Difference between study visits in time (min) in hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  13. Difference between study visits in time (%) in hypoglycemia (plasma glucose < 3.9 mmol/l) (per protocol) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  14. Difference between study visits in incidence rate of rescue carbohydrate administration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  15. Difference between study visits in time (min) to rescue carbohydrate administration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  16. Difference between study visits in plasma dasiglucagon Area Under the Curve (AUC) from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  17. Difference between study visits in peak plasma dasiglucagon concentration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  18. Difference between study visits in time to peak plasma dasiglucagon concentration from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  19. Difference between study visits in serum insulin concentration at visit start (t = 0) and immediately before administration of the intervention (t-intervention = 0)

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

  20. Difference between study visits in serum insulin AUC from 0-180 minutes post-intervention

    Time frame · Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

8 results

Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study.

Laugesen et al. 2022Diabetes carecited by 9

PMID 35475907DOI 10.2337/dc21-2304PUB-35475907

Rights unknown8 results
Source linkSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 18-64 years * Duration of T1D ≥ 3 years * Use of CSII or MDI therapy for ≥ 6 months * Current use of Novorapid (change from another fast-acting insulin to Novorapid prior to study initiation is allowed) * HbA1c ≤ 8.0% * Regular use of carbohydrate counting in the judgement of the investigator Exclusion Criteria: * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start * History of allergy or intolerance to glucagon or glucagon-like products * Patients with pheochromocytoma * Clinically significant ECG abnormalities * Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection) * Inability to understand the individual information and to give informed consent * Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject * Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the individual unsuitable for study participation

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