Loading clinical trials...

A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03378635•Zealand Pharma

View on ClinicalTrials.gov

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. Additionally to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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%

Exclusion Criteria

•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
•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
+3 more criteria

Locations (5)

ProSciento

Chula Vista, California, United States

Clinical Research Center, Medizinische Universität Graz

Graz, Austria

LMC Diabetes & Manna Research

Toronto, Canada

Profil

Mainz, Germany

Profil

Neuss, Germany

Key Dates

Start Date

December 7, 2017

Primary Completion Date

April 27, 2018

Completion Date

May 25, 2018

Last Updated

June 10, 2021

Enrollment

170

ACTUAL participants

Conditions

HypoglycemiaDiabetes Mellitus, Type 1

Interventions

Dasiglucagon

DRUG

GlucaGen

DRUG

Placebo

DRUG

Restoration of Hypoglycemia Awareness With Metoclopramide

NCT03970720

Hypoglycemia Unawareness

View study

RECRUITINGPHASE3

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

NCT04786262

Diabetes Mellitus, Type 1Impaired Hypoglycemic Awareness+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Restoration of Hypoglycemia Awareness With Metoclopramide

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

Closed Loop and Education for Hypoglycemia Awareness Restoration

Diagnosing and Treating Low Blood Sugar Levels

Pasteurised Donor Human Milk Supplementation for Term Babies