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

February 8, 2021 updated by: Steno Diabetes Center Copenhagen
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.

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

Near-normalization of blood glucose levels through intensive insulin therapy has shown to reduce the risk of diabetes late complications, but the approach is associated with two major side effects: hypoglycemia and weight gain. Although management of hypoglycemia through oral carbohydrate consumption is generally effective, the approach can lead to excessive carbohydrate intake and cause rebound hyperglycemia. It has previously been demonstrated that subcutaneous (s.c.) low-dose glucagon can be utilized to effectively treat mild hypoglycemia in people with type 1 diabetes. However, the instability in aqueous solution of currently available glucagon and the need for reconstitution with sterile water immediately prior to administration has limited its clinical role outside emergency settings. Due to the stability and ready-to-use formulation, dasiglucagon does not hold the limitations known for the currently available glucagon preparations.

The aim of this randomized, partially single-blinded, three-arm cross-over study is to compare the efficacy of low-dose dasiglucagon (80 and 120 μg) to oral carbohydrate (15 g) consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes. On each study visit (separated by ≥ 3 days), an initial insulin bolus will be administered (at t = 0) aiming for a plasma glucose (PG) level of 3.0 mmol/l. When reaching 4.5 mmol/l, the intervention (s.c. dasiglucagon or oral carbohydrates) will be administered (t-intervention = 0), whereafter PG will me monitored for an additional 180 min.

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.
20

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 to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Single

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.
Experimental: 80 µg s.c. dasiglucagon
80 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l
Drug: Dasiglucagon
Abdominal s.c. administration
Experimental: 120 µg s.c. dasiglucagon
120 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l
Drug: Dasiglucagon
Abdominal s.c. administration
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
Other: Carbohydrate (dextrose tablets)
Oral administration

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

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
Time Frame
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in dose (units) of insulin bolus at study start (t = 0)
Time Frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in change in Edinburgh Hypoglycemia Symptoms Scale (EHSS) 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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain, palpitations and hunger 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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of vomiting 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)
Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

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, MD, PhD Candidate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 2, 2020

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.
January 4, 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 4, 2021

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).
June 24, 2020

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.
June 26, 2020

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.
June 29, 2020

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.
February 9, 2021

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.
February 8, 2021

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.
February 1, 2021

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.
  • H-20013256 (Registry Identifier: Regional Scientific Ethics Committee)
  • 2020-000551-12 (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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Conditions

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