Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT04764968Other id77119Other idH-21000002Other id2020-005745-16

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 24 participants (actual)
Sponsor: Steno Diabetes Center Copenhagen · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Denmark
Start: 27 Apr 2021
Primary completion: 30 Dec 2021
Completion: 28 Jan 2022
First posted: 21 Feb 2021
Last update posted: 7 Sept 2022
Conditions: Type 1 Diabetes · Hypoglycemia

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 2
Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes
NCT04764968
27 Apr 2021 to 28 Jan 2022

Registry summary

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

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.

Interventions

DasiglucagonDrug

Arms2

No intervention
Usual care
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.
Experimental
Dasiglucagon
During the 'dasiglucagon' period, participants will use pen-administered low-dose (80 µg) dasiglucagon to treat or prevent episodes of hypoglycemia.

Primary outcomes1

Outcomes the sponsor listed as primary.

Difference in percentage of time in range between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l

Secondary outcomes(13)

Difference in percentage of time in hypoglycemia between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
Sensor glucose level \< 3.9 mmol/l
Difference in percentage of time in hyperglycemia between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
Sensor glucose level \> 10 mmol/l
Difference in coefficient of variation (%) between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference between successful cases (%) of hypoglycemia treatment between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
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
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
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
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
Difference in successful cases (%) of hypoglycemia prevention between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
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
Difference in time from hypoglycemia treatment to euglycemia between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l
Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration
Time frame · 2-week 'dasiglucagon' period
Difference between the average daily carbohydrate intake between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
Registered on the insulin pump
Difference between the average total daily insulin dose between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods
Time frame · 2-week 'usual care' period and 2-week 'dasiglucagon' period
Registry description
Intensity: mild/moderate/severe
Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire
Time frame · At the end-of-study visit (estimated week 6)
Registry description
Scoring likely OR very likely on a four-point Likert scale
Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies
Time frame · Measured 4 weeks after the 'dasiglucagon' period

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 · 2023

7 results

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.

Laugesen et al. 2023Diabetologiacited by 2

PMID 37037948PMC10244275DOI 10.1007/s00125-023-05909-4PUB-37037948

CC BY7 results

Download PDF See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 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 * 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 * 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

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