AzTrials
AzTrials

HypoglycemiaPhase 3NCT03378635

A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

A Phase 3 study testing Dasiglucagon and GlucaGen in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Zealand Pharma at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus (T1DM) with insulin-induced hypoglycemia. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypoglycemia, Diabetes Mellitus, Type 1
What is being tested?
Dasiglucagon and GlucaGen
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
5 sitesin 4 countries
Study dates
7 Dec 2017to 25 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male subjects with type 1 diabetes mellitus (T1DM) for at least 1 year, diagnostic criteria as defined by the American Diabetes Association
  • Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
  • Hemoglobin A1c <10%

Who cannot join

  • Previously treated with dasiglucagon (previously referred to as ZP4207)
  • Known or suspected allergy to trial product(s) or related products
  • Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating.
  • History of hypoglycemic events associated with seizures in the last year prior to screening
  • History of severe hypoglycemia in the last month prior to screening
  • Active malignancy within the last 5 years
Show all 13Show fewer
  • Current bleeding disorder, including anti-coagulant treatment
  • Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor)
  • Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial
  • Clinically significant abnormal ECG at screening as judged by the investigator
  • Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening
  • Surgery or trauma with significant blood loss within the last 2 months prior to screening
  • A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Germany2 sites

  • Profil

    Mainz

  • Profil

    Neuss

Other trials in Germany

United States1 site

  • ProSciento

    Chula Vista, California, 91911

Other trials in United States

Austria1 site

  • Clinical Research Center, Medizinische Universität Graz

    Graz

Other trials in Austria

Canada1 site

  • LMC Diabetes & Manna Research

    Toronto

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Double-blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus Compared to Placebo and With Reference to GlucaGen

The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus (T1DM) with insulin-induced hypoglycemia. Additionally to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.

Read the detailed description

This was a global, multicenter, randomized, parallel, and double-blind clinical trial confirming the efficacy and safety of dasiglucagon for insulin-induced hypoglycemia in patients with T1DM. The patients were randomized 2:1:1 to receive a single subcutaneous 0.6 mg dose of dasiglucagon, placebo, or a 1 mg dose of GlucaGen and followed for at least 28 days after receiving treatment.

Being tested
Dasiglucagon, GlucaGen, Placebo
Keywords
Dasiglucagon, Glucagon analog
Medical subject headings
Hypoglycemia, Diabetes Mellitus, Type 1

What participants receive

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

  • DasiglucagonDrug

    Also called ZP4207

    Glucagon analog

  • GlucaGenDrug

    Also called GlucaGen HypoKit

    Native glucagon

  • PlaceboDrug

    Also called Placebo for dasiglucagon

    Placebo for dasiglucagon

Study groups in NCT03378635
Study groupRoleWhat they receive
DasiglucagonExperimentalSingle fixed dose (s.c.injection) of dasiglucagon
Receives: Drug: Dasiglucagon
PlaceboPlacebo comparatorSingle fixed dose (s.c.injection) of placebo
Receives: Drug: Placebo
GlucaGen®Active comparatorSingle fixed dose (s.c.injection) of GlucaGen®
Receives: Drug: GlucaGen

What is being measured

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

  1. Time to Plasma Glucose Recovery

    Plasma glucose recovery is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. The outcome measure used a Kaplan-Meier estimate with 95% confidence interval. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.

    Measured: 0-45 minutes after dosing

Secondary outcomes (11)

  1. Plasma Glucose Recovery

    Plasma glucose recovery within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after study drug injection without administration of rescue IV glucose. Plasma glucose recovery was defined as the first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose.

    Measured: 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection

  2. Plasma Glucose Changes From Baseline

    Plasma glucose changes from baseline at 30 minutes, 20 minutes, 15 minutes and 10 minutes after study drug injection without administration of rescue intravenous glucose

    Measured: 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection

  3. Time to Target

    Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose. The outcome measure used a Kaplan-Meier estimate with 95% confidence interval. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.

    Measured: 0-45 minutes after dosing

  4. Pharmacodynamics - Area Under the Effect Curve

    Plasma glucose response as area under the effect curve (AUE) above baseline from time zero to 30 minutes. Samples were collected pre-dose, and at 4, 6, 8, 10, 12, 15, 17, 20, 25 and 30 minutes after dosing.

    Measured: 0-30 minutes after dosing

  5. Pharmacokinetics - Area Under the Plasma Concentration Curve

    Area under the drug concentration curve from time zero to 90 minutes, AUC0-90min. To calculate the AUC the standard trapezoidal method was used, based on actual rather than nominal time points. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.

    Measured: 0-90 minutes after dosing

  6. Pharmacokinetics - Area Under the Plasma Concentration Curve

    Area under the drug concentration curve from time zero to 120 minutes, AUC0-120min. To calculate the AUC the standard trapezoidal method was used, based on actual rather than nominal time points. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.

    Measured: 0-120 minutes after dosing

  7. Pharmacokinetics - Maximum Plasma Concentration

    Maximum plasma drug concentration (Cmax). Maximum plasma drug concentration was determined as the maximum of all valid plasma dasiglucagon/glucagon concentrations. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.

    Measured: 0-120 minutes after dosing

  8. Pharmacokinetics - Time to Maximum Plasma Concentration

    Time to maximum plasma drug concentration (tmax). Median Tmax was determined as the time point where the maximum of all valid plasma dasiglucagon/glucagon concentration measurements for each measurement series was observed. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.

    Measured: 0-120 minutes after dosing

  9. Immunogenicity - Occurence of Anti-drug Antibodies

    Occurence of antibodies against dasiglucagon/GlucaGen

    Measured: 28 days

  10. Rescue Infusion of IV Glucose During the Hypoglycemic Clamp Procedure

    Number of patients receiving administration of rescue infusion of IV glucose during the hypoglycemic clamp procedure. IV = intravenous

    Measured: 0-45 minutes after dosing

  11. Time to First Rescue Infusion of IV Glucose

    Time to first rescue administration of rescue infusion of IV glucose. IV = intravenous

    Measured: 0-45 minutes after dosing

Timeline

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

  1. First posted20 Dec 2017
  2. Study start7 Dec 2017
  3. Primary completion27 Apr 2018
  4. Study completion25 May 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378635
Sponsor's protocol ID
ZP4207-16137
Status last verified
May 2021
First submitted
8 Dec 2017
Last updated
10 Jun 2021
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pieber TR, Aronson R, Hovelmann U, Willard J, Plum-Morschel L, Knudsen KM, Bandak B, Tehranchi R. Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial. Diabetes Care. 2021 Jun 1;44(6):1361-1367. doi: 10.2337/dc20-2995.

    PubMed 35239971

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dasiglucagon and GlucaGen in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Zealand Pharma at 5 sites in 4 countries.

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 3 inclusion and 13 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, United States, Austria, Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Plasma Glucose Recovery (time frame: 0-45 minutes after dosing). 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 NCT03378635, 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 10 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in