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Study on the Effects of Verapamil Hydrochloride for Adults with Type 1 Diabetes to Preserve Beta-Cell Function

Verified siteRegistered drugNo placebo
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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 effects of a medication called Verapamil SR on individuals diagnosed with Type 1 diabetes mellitus. Type 1 diabetes is a condition where the body does not produce insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. The medication being tested, Verapamil SR, is a type of drug known as a calcium channel blocker, which is commonly used to treat high blood pressure and heart-related conditions. In this study, it is being explored for its potential to help preserve the function of beta cells in the pancreas, which are responsible for producing insulin.

The purpose of the study is to observe how Verapamil SR affects the preservation of beta-cell function over a long period. Participants in the study will take 360 mg of Verapamil SR orally once a day. The study will last for 24 months, during which participants will have their beta-cell function measured at the start and at the end of the study. This will be done using a test called the mixed-meal tolerance test (MMTT), which helps assess how well the body is producing insulin. Some participants may have previously been treated with either a placebo or Verapamil SR for 12 months in a prior study.

Throughout the study, changes in blood glucose control, insulin requirements, and any severe low blood sugar episodes will be monitored. Additionally, the study will track any adverse events or changes in vital signs, such as heart rate and blood pressure, to ensure the safety of the participants. The study aims to provide valuable insights into whether Verapamil SR can help maintain insulin production in people with Type 1 diabetes, potentially leading to better management of the condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of the trial

    Upon joining the trial, the participant will start taking Verapamil SR at a dose of 360 mg. This medication is taken orally once a day.

    The purpose of this medication is to explore its effect on preserving the function of beta cells in individuals with Type 1 diabetes.

  2. Step 2

    Baseline assessment

    At the start of the trial, a baseline assessment will be conducted. This includes measuring the C-peptide response to a mixed-meal tolerance test (MMTT).

    C-peptide is a substance made in the pancreas, and its levels can indicate how well the beta cells are functioning.

  3. Step 3

    6-month follow-up

    After six months of taking Verapamil SR, another assessment will be conducted.

    This includes measuring changes in C-peptide levels, blood glucose control (HbA1C), and insulin requirements.

  4. Step 4

    12-month follow-up

    At the 12-month mark, the participant will undergo similar assessments as the 6-month follow-up.

    The focus will be on monitoring changes in C-peptide levels, blood glucose control, and insulin needs.

  5. Step 5

    18-month follow-up

    Eighteen months into the trial, assessments will be repeated to track any changes in the participant's condition.

    This includes evaluating C-peptide levels, blood glucose control, and insulin requirements.

  6. Step 6

    24-month final assessment

    At the end of the 24-month period, a final assessment will be conducted.

    The primary focus will be on the change in C-peptide levels from the baseline, as well as any changes in blood glucose control and insulin needs.

  7. Step 7

    Monitoring of adverse events

    Throughout the trial, any adverse events, changes in vital signs, and other safety parameters will be monitored.

    This includes tracking severe hypoglycemic episodes and episodes of diabetic ketoacidosis.

Who can join the trial?

4 criteria

  • Must be part of the Ver-A-T1D trial, either currently receiving treatment with a **Placebo** or **Verapamil SR** (240 mg or 360 mg), or have completed a specific visit in the study and plan to continue with the next visit on active treatment.
  • Must have given written informed consent, which means you agree to participate in the study after understanding all the details.
  • Must be **18 years or older** at the time of giving consent.
  • Must have a **fasting C-peptide level** of at least 50 pmol/L. C-peptide is a substance made in the pancreas, and its level helps to understand how well the pancreas is working.

Who cannot join the trial?

6 criteria

  • Patients who do not have Type 1 diabetes mellitus (T1D) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to take the study medication, Verapamil SR, cannot participate.
  • Patients who have not been previously treated with either a placebo or Verapamil SR for 12 months in the Ver-A-T1D trial cannot participate.
  • Patients who have a fasting C-peptide level less than 50 pmol/L cannot participate. C-peptide is a substance made in the pancreas, and its level helps to understand how well the pancreas is working.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
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Investigated drugs

Verapamil SR is a medication used in this trial to explore its long-term effects on preserving beta-cell function in adults with Type 1 diabetes. It is taken orally once a day. The study aims to see how this medication affects the body's ability to produce insulin by measuring a specific marker called C-peptide.

What is already known about the treatment

Verapamil SR – This medication is administered orally in a sustained-release form, taken once daily. It is currently being studied in clinical trials for its potential benefits in preserving beta-cell function in patients with Type 1 diabetes mellitus. Verapamil SR is primarily used as a calcium channel blocker, which means it works by inhibiting the influx of calcium ions into heart and smooth muscle cells, leading to relaxation of these muscles. This mechanism is traditionally used to treat high blood pressure and certain heart conditions, but its role in diabetes management is under investigation.

Investigated diseases

Type 1 Diabetes Mellitus – This is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in adolescence or early adulthood but can develop at any age. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. Over time, this leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the condition advances, it requires careful management of blood sugar levels through insulin therapy and lifestyle adjustments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515234-33-00Protocol codeVer-A-LongEstimated enrolment40 patientsSponsorMedical University Of Graz

sourced from the EU Clinical Trials Register and site verification

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