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

September 5, 2022 updated by: Steno Diabetes Center Copenhagen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Steno Diabetes Center Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Dasiglucagon
Abdominal s.c. administration using a multi-dose reusable pen injector

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in percentage of time in range between the two study periods
Time Frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l
2-week 'usual care' period and 2-week 'dasiglucagon' period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in percentage of time in hypoglycemia between the two study periods
Time Frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Sensor glucose level < 3.9 mmol/l
2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in percentage of time in hyperglycemia between the two study periods
Time Frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Sensor glucose level > 10 mmol/l
2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in coefficient of variation (%) between the two study periods
Time Frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
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
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
2-week 'usual care' period and 2-week 'dasiglucagon' period
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
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
2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in successful cases (%) of hypoglycemia prevention between the two study periods
Time Frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
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
2-week 'usual care' period and 2-week 'dasiglucagon' period
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
Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l
2-week 'usual care' period and 2-week 'dasiglucagon' period
Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration
Time Frame: 2-week 'dasiglucagon' period
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
Registered on the insulin pump
2-week 'usual care' period and 2-week 'dasiglucagon' period
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
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
Intensity: mild/moderate/severe
2-week 'usual care' period and 2-week 'dasiglucagon' period
Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire
Time Frame: At the end-of-study visit (estimated week 6)
Scoring likely OR very likely on a four-point Likert scale
At the end-of-study visit (estimated week 6)
Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies
Time Frame: Measured 4 weeks after the 'dasiglucagon' period
Measured 4 weeks after the 'dasiglucagon' period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of device failures/malfunctions
Time Frame: 2-week 'dasiglucagon' period
2-week 'dasiglucagon' period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Steno Diabetes Center Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Laugesen, MD, Steno Diabetes Center Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 77119
  • H-21000002 (OTHER: Regional Scientific Ethics Committee)
  • 2020-005745-16 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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