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Study on Verapamil and Exenatide for Adults with Type 1 Diabetes to Measure Changes in Beta Cell Mass

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 Type 1 Diabetes, a condition where the body's immune system attacks the insulin-producing cells in the pancreas. The study will use a medication called Verapamil, which is a type of drug known as a calcium-channel blocker, and another substance called Exenatide, which is a protein-based medication. The purpose of the study is to explore how these treatments affect the mass of beta cells in the pancreas, which are responsible for producing insulin.

Participants in the study will undergo a special imaging process called PET/CT to measure how much of a substance called 68Ga-NODAGA-exendin is taken up by the pancreas. This will help researchers see the differences in beta cell mass before and after treatment, as well as compare results between those receiving the treatment and those receiving a placebo. The study will track these changes over a period of time to understand the effects of the treatments on the pancreas.

The study will involve regular imaging sessions to monitor changes in the pancreas, and these will be compared with other measurements related to insulin production, such as C-peptide and proinsulin levels. The goal is to gain insights into how these treatments might help preserve or improve the function of insulin-producing cells in people with Type 1 Diabetes.

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

    Participation begins with an initial assessment to confirm eligibility. This includes verifying that the individual is part of the VER-A-T1D trial, has not started treatment or placebo, and has provided written informed consent. The individual must be at least 18 years old.

  2. Step 2

    Baseline imaging

    A baseline PET/CT scan is conducted to measure the pancreatic uptake of a substance called 68Ga-NODAGA-exendin. This scan helps determine the initial beta cell mass.

  3. Step 3

    Medication administration

    The individual receives verapamil orally and exenatide via intravenous bolus. The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Follow-up imaging

    After 12 months, a follow-up PET/CT scan is performed to assess changes in the pancreatic uptake of 68Ga-NODAGA-exendin. This helps evaluate any differences in beta cell mass over time.

  5. Step 5

    Data analysis

    The study analyzes the total pancreatic uptake of 68Ga-NODAGA-exendin to determine changes in beta cell mass. Secondary analyses include examining changes in C-peptide and proinsulin/preproinsulin levels, as well as differences in uptake between individuals and over time.

Who can join the trial?

3 criteria

  • Must be part of the VER-A-T1D trial but have not yet started treatment or received a placebo.
  • Must have given written informed consent, which means you agree to participate after being fully informed about the study.
  • Must be at least 18 years old at the time of giving consent.

Who cannot join the trial?

4 criteria

  • Individuals who do not have type 1 diabetes mellitus cannot participate. This is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
  • Participants must be within certain age ranges, specifically between 18 and 65 years old.
  • Both males and females are eligible to participate.
  • Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.
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Investigated drugs

68Ga-NODAGA-exendin is a special imaging agent used in this study. It helps doctors see how much of a certain type of cell, called beta cells, are in the pancreas. This is important because beta cells make insulin, which helps control blood sugar levels. The study uses a type of scan called PET/CT to take pictures of the pancreas before and after treatment to see if there are any changes in the number of beta cells.

What is already known about the treatment

68Ga-NODAGA-exendin – This medication is administered through an injection and is used in a PET/CT scan to visualize the pancreas. It is currently being studied in clinical trials to assess its effectiveness in detecting changes in beta cell mass in individuals with type 1 diabetes. The main therapeutic indication is to help understand the differences in beta cell mass before and after treatment. At the molecular level, it works by binding to GLP-1 receptors, which are present on beta cells, allowing for imaging of these cells. It is classified as a diagnostic radiopharmaceutical agent.

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 childhood or adolescence but can develop in adults. The immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. As a result, blood sugar levels become elevated, leading to various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, high blood sugar levels can cause damage to various organs and tissues in the body. The progression of the disease requires careful management of blood sugar levels to maintain health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518554-17-00Estimated enrolment30 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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