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

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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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

4 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Verapamil – Verapamil is administered orally and is currently being studied in clinical trials for its potential to preserve insulin secretion in children with recent onset Type 1 diabetes. It is a well-known medication in medical literature, primarily used for treating high blood pressure and certain heart conditions. The main therapeutic indication in this trial is to maintain the function of beta cells in the pancreas, which are responsible for insulin production. At the molecular level, Verapamil works by blocking calcium channels, which can influence insulin secretion and beta cell survival. It is classified pharmacologically as a calcium channel blocker.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2024-515106-30-00Protocol codeVeradiab-1Estimated enrolment36 patientsSponsorLinkopings Universitet

sourced from the EU Clinical Trials Register and site verification

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