Study on Verapamil to Preserve Insulin Secretion in Children with Recent Onset Type 1 Diabetes

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What is this study about?

This clinical trial is focused on studying Type 1 diabetes, a condition where the body’s immune system attacks insulin-producing cells in the pancreas. The study aims to explore the effects of a medication called Verapamil, which is typically used to treat high blood pressure and heart-related issues, to see if it can help preserve the remaining insulin-producing cells in children who have recently been diagnosed with Type 1 diabetes.

The trial involves giving participants either Verapamil or a placebo in the form of oral capsules. The purpose of the study is to evaluate whether Verapamil can help maintain the function of the insulin-producing cells over time. Participants will be randomly assigned to receive either the medication or the placebo, and neither the participants nor the researchers will know who is receiving which treatment, a method known as “double-blind.”

Throughout the study, participants will have regular check-ups to monitor their health and the function of their insulin-producing cells. The study will last for several years, with the goal of understanding how **Verapamil** affects the progression of **Type 1 diabetes** in children. This research could potentially lead to new ways to manage the disease and improve the quality of life for those affected.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes verifying a diagnosis of Type 1 diabetes within the last three months, checking fasting C-peptide levels, and confirming the presence of diabetes-related antibodies.

Participants must be between 4 and 9.99 years old at the time of diagnosis.

2 randomization and treatment assignment

Participants are randomly assigned to receive either Verapamil or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives which treatment.

The medication is administered orally.

3 treatment phase

Participants take the assigned medication daily. The treatment aims to preserve the function of insulin-producing cells in the pancreas.

The primary focus is on monitoring the frequency of adverse events over an 18-month period.

4 monitoring and evaluation

Regular monitoring includes measuring metabolic control through HbA1c levels and insulin requirements. Continuous glucose monitoring may be used.

The study evaluates changes in C-peptide levels during a mixed-meal tolerance test (MMTT) from the start of the trial to 24 months.

5 follow-up and conclusion

The trial concludes with a final assessment of C-peptide levels and insulin requirements. The goal is to determine the effectiveness of Verapamil in preserving insulin secretion.

The study is expected to end by June 2028.

Who Can Join the Study?

Patients and their caregivers or parents must give their informed consent, which means they agree to participate after understanding the study details.
The patient must have been diagnosed with Type 1 diabetes according to the American Diabetes Association (ADA) classification within the last 3 months before the screening.
The patient must have a fasting C-peptide level greater than 0.12 nmol/ml. C-peptide is a substance made in the pancreas, and its level helps to understand how much insulin the body is producing.
The patient must have elevated levels of any diabetes-related antibodies. These are proteins made by the immune system that can attack the body’s own cells, such as GADA, IAA, IA-2A, or ZnT8A.
The patient must be between the ages of 4.00 and 9.99 years at the time of their Type 1 diabetes diagnosis.

Who Cannot Join the Study?

Individuals who do not have Type 1 diabetes cannot participate. Type 1 diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
Participants must be within a specific age range, which is not specified here, but if you are outside this range, you cannot join.
Both males and females can participate, but if you do not identify as either, you may not be eligible.
If you belong to a vulnerable population, which means you might need special protection or care, you may not be able to participate.

Where you can join this trial?

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Site Name	City	Country	Status
Region Oestergoetland	Linkoping	Sweden
Region Joenkoepings Laen	Jönköping	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.02.2025

Trial locations

Investigated drugs:

Verapamil

Verapamil is a medication being tested in this clinical trial. It is usually used to treat high blood pressure and certain heart conditions. In this study, researchers are exploring whether Verapamil can help preserve the function of insulin-producing cells in children who have recently been diagnosed with Type 1 diabetes. The goal is to see if Verapamil can help maintain the body’s ability to produce insulin naturally, which could be beneficial in managing diabetes.

Investigated diseases:

Type 1 diabetes mellitus

Type 1 Diabetes – This is an autoimmune condition where the body’s immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body produces little to no insulin, a hormone essential for allowing glucose to enter cells for energy. Without sufficient insulin, blood sugar levels rise, leading to symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, high blood sugar can cause damage to various organs and systems in the body. The disease often begins in childhood or young adulthood, but it can occur at any age. Management involves monitoring blood sugar levels and administering insulin to maintain normal glucose levels.

Trial ID:

2024-515106-30-00

Protocol code:

Veradiab-1

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Verapamil to Preserve Insulin Secretion in Children with Recent Onset Type 1 Diabetes

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