Long-term Safety Study of Dasiglucagon for Children with Congenital Hyperinsulinism

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called Dasiglucagon for children with a condition known as Congenital Hyperinsulinism (CHI). CHI is a rare condition where the body produces too much insulin, leading to low blood sugar levels. The treatment being tested, Dasiglucagon, is given as a solution for injection and is used with a special device called the Accu-Chek Spirit Combo insulin pump. This pump helps deliver the medication in a controlled manner to manage the condition.

The purpose of this study is to evaluate how safe Dasiglucagon is when used over a long period in children with CHI. Participants in the study will receive Dasiglucagon through a small tube placed under the skin, which is connected to the insulin pump. The study will monitor the children for any side effects and how well the treatment helps in managing their blood sugar levels. The study will also look at how much additional sugar needs to be given through a tube to treat low blood sugar and the timing of any necessary surgeries related to the pancreas.

Throughout the study, researchers will keep track of any adverse events, which are any unwanted effects that might occur during the treatment. They will also measure how often and how long the children’s blood sugar levels drop below certain thresholds. This information will help determine the overall safety and effectiveness of Dasiglucagon for children with CHI. The study is expected to continue until November 2026.

1 joining the trial

Participation begins after completing treatment in either Trial ZP4207-17103 or ZP4207-17109.

A positive benefit-risk assessment for treatment with dasiglucagon is required, documented by the investigator.

For females of child-bearing potential, a negative serum pregnancy test is necessary at the start.

Sexually active female participants and their partners must use effective contraception or abstain from sexual activity during the trial and for 30 days after the last dose.

2 treatment administration

Dasiglucagon is administered as a subcutaneous infusion. This means the medication is given under the skin using a solution for injection.

The treatment aims to evaluate the long-term safety of dasiglucagon in children with congenital hyperinsulinism.

3 monitoring and assessments

The primary focus is on monitoring any adverse events that may occur during the trial.

Secondary assessments include measuring the total amount of carbohydrates given through a tube to treat low blood sugar, the time until the removal of the tube, and the time until any pancreatic surgery.

Continuous glucose monitoring (CGM) is used to track the percentage of time blood sugar levels are below 70 mg/dL and the rate of hypoglycemia episodes.

4 trial duration

The trial is expected to continue until November 30, 2026.

Participants are required to comply with all trial procedures throughout the duration.

Who Can Join the Study?

The child must have completed treatment in either Trial ZP4207-17103 or ZP4207-17109.
The child is expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon. This means the treatment is likely to be more helpful than harmful, based on how it affects blood sugar, how well the child can handle it, and any side effects experienced in the previous trial.
If the child is a female who can become pregnant, she must have a negative pregnancy test at the start of the trial.
Sexually active female patients and their partners must use acceptable contraception or avoid sexual activity from the start of the trial until 30 days after the last dose of the trial drug. Acceptable methods include hormonal contraceptives (like birth control pills or patches) or barrier methods (like condoms or diaphragms with spermicide). Abstinence is only accepted if it is the patient’s usual lifestyle.
The child must be able and willing to follow the trial procedures.
After receiving information about the trial, the child must agree to participate if required, and one or both parents or a guardian must provide signed consent before any trial activities begin. If local rules require, both parents must give permission unless one parent is not available or responsible for the child.

Who Cannot Join the Study?

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
Uwmmsccyzdhjdifolzbeg Dceezmazxoq Aba	Duesseldorf	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	02.05.2019

Trial locations

Investigated drugs:

Dasiglucagon

Dasiglucagon is a medication being studied for its long-term safety and effectiveness in treating children with congenital hyperinsulinism (CHI). It is administered as a subcutaneous infusion, which means it is given under the skin using a small needle. The goal of using dasiglucagon in this trial is to help manage blood sugar levels in children with CHI, a condition where the body produces too much insulin, leading to low blood sugar levels.

Congenital Hyperinsulinism – Congenital hyperinsulinism is a rare condition in which the pancreas produces too much insulin, leading to low blood sugar levels, or hypoglycemia. This condition is present from birth and can cause symptoms such as irritability, poor feeding, and lethargy in infants. As the child grows, they may experience episodes of low blood sugar, which can affect their development and overall health. The condition can vary in severity, with some children experiencing frequent and severe hypoglycemic episodes. Over time, managing blood sugar levels becomes crucial to prevent potential complications. The progression of the disease can differ, with some children requiring surgical intervention if medical management is insufficient.

Trial ID:

2024-514007-34-00

Protocol code:

ZP4207-17106

NCT ID:

NCT03941236

Trial Phase:

Therapeutic confirmatory (Phase III)

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Long-term Safety Study of Dasiglucagon for Children with Congenital Hyperinsulinism

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