Otto Von Guericke Universitaet Magdeburg
Magdeburg, Germany
Not recruitingRare disease
Long-term Safety Study of Dasiglucagon for Children with Congenital Hyperinsulinism
Verified siteInvestigational
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- 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.
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Verified Verified Universitaetsklinikum Duesseldorf AöR
Duesseldorf, Germany
Trial locations
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Investigated drugs
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.
What is already known about the treatment
Dasiglucagon – Dasiglucagon is administered as a subcutaneous infusion, primarily used in the treatment of children with congenital hyperinsulinism. It is currently being evaluated in clinical trials to assess its long-term safety and efficacy for this condition. The medication works by increasing blood glucose levels, counteracting the effects of excessive insulin. It belongs to the pharmacological class of glucagon receptor agonists, which help to raise blood sugar by stimulating the liver to release stored glucose.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-514007-34-00Protocol codeZP4207-17106Estimated enrolment42 patientsSponsorZealand Pharma A/S
sourced from the EU Clinical Trials Register and site verification
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