All studies
CompletedPhase IIInterventional

Exploratory effect of long-term Verapamil therapy in adults with Type 1 diabetes mellitus (Ver-A-Long)

The Ver-A-Long study is looking into whether a medicine called Verapamil, usually used for high blood pressure, can help people with Type 1 diabetes. Previous research has suggested Verapamil might help the body's pancreas make more insulin. This study aims to see if taking a slow-release form of Verapamil (360 mg daily) for two years can help preserve the ability of the pancreas to produce insulin in adults with Type 1 diabetes, and to check how safe it is over this time. It also tracks how much insulin people need, their blood sugar levels, and any serious low blood sugar events. Participants must be adults already taking part in a previous Verapamil study for Type 1 diabetes.

At a glance

Status
Completed
Phase
Phase II
Sponsor
Medical University of Graz
Enrolment target
30
Start
04 Nov 2024
Estimated completion
12 May 2025

What is this study about?

You might be wondering what this "Ver-A-Long" study is all about. Well, Type 1 diabetes happens when your body stops making enough insulin, a hormone vital for managing blood sugar. Scientists have been exploring ways to help the body keep making some of its own insulin, even after a Type 1 diabetes diagnosis. One medicine that has shown some promise is Verapamil, which is typically used to treat high blood pressure.

Previous studies, including those in animals and early human trials, suggest that Verapamil might help the special cells in the pancreas (called beta cells) that produce insulin. If these cells can be encouraged to work better or last longer, it could mean people with Type 1 diabetes might need less insulin from injections and have better control over their blood sugar. The "Ver-A-Long" study is a deeper look into this idea.

Specifically, this study wants to see if taking Verapamil every day for two years can help protect and keep these insulin-making cells working in adults who have Type 1 diabetes. It's a second step for people who have already been taking part in a related Verapamil study. By continuing treatment and monitoring closely, researchers hope to understand the long-term effects and safety of Verapamil, potentially paving the way for new ways to manage Type 1 diabetes in the future.

Key takeaways

  • Exploring if Verapamil helps preserve natural insulin production in Type 1 diabetes.
  • Specifically for adults already in the 'Ver-A-T1D' study.
  • Involves taking daily Verapamil for two years.
  • Regular clinic visits and phone check-ups.
  • Aims to understand long-term effects and safety.
  • Could help future Type 1 diabetes patients.

Who may be eligible?

This study is specifically designed for adults who are already involved in another related study called "Ver-A-T1D." To join Ver-A-Long, you must have been taking either Verapamil or a dummy pill (placebo) in the Ver-A-T1D study for about 11 to 12 months, and be nearing the end of that part of the study.

You need to be 18 years old or older, and your body must still be making a small amount of insulin. This is checked by a blood test that measures something called C-peptide, which tells us your pancreas is still working a little.

There are also some health conditions that would mean you can't join. For example, if you are pregnant, breastfeeding, or planning to get pregnant, or if you have certain serious health problems like cancer (other than some skin cancers), or severe liver or kidney issues. You also can't be taking certain other medications or herbal remedies that might interfere with Verapamil.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you currently taking part in the Ver-A-T1D study?
  2. Are you 18 years old or older?
  3. Has a doctor told you that your body still makes some insulin (checked by a C-peptide test)?
  4. Are you not pregnant, breastfeeding, or planning to become pregnant during the next two years?
  5. Do you have any serious, active health problems (other than Type 1 diabetes) that your doctor might think would interfere with the study?
  6. Are you not using certain medicines or herbal products (like St. John's Wort or grapefruit juice) that could affect Verapamil?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given 360 mg of Verapamil daily. Initially, you'll start with a lower dose (120 mg) and gradually increase it over the first three weeks until you reach the full daily dose. This treatment will continue for two years.

During these two years, you'll need to visit the clinic about 6 or 7 times, depending on when you start. You'll also have 4 phone calls with the study team. These visits and calls are important for checking how you're doing, monitoring your health, and making sure the medication isn't causing any problems. They will track things like your blood sugar levels, how much insulin you need, and any episodes of very low blood sugar. Your heart health will be checked with an ECG, and blood tests will be done regularly.

Potential risks and benefits

While you might not directly feel better or healthier by taking part in this study, the information gathered from your participation is very valuable. It could help doctors understand more about Type 1 diabetes and potentially lead to better treatments for people with the condition in the future. You will also get regular health checks, tests, and discussions with the study doctors. As with any medication, there's always a chance of side effects from Verapamil. There's also a risk of experiencing episodes of very low blood sugar or other diabetes-related complications, especially as the study tracks these events. The study includes close monitoring and safety checks to manage these potential risks. You are free to stop participating in the study at any time without affecting your usual medical care.

Locations (12)

  • St. Bartholomews Hospital
    City only
    London, United Kingdom
  • Queen Elizabeth Hospital
    Approximate
    Birmingham, United Kingdom
  • Oxford Centre for Diabetes, Endocrinology and Metabolism
    City only
    Oxford, United Kingdom
  • University Hospital of Wales
    Approximate
    Cardiff, United Kingdom
  • Royal Hallamshire Hospital
    Approximate
    Sheffield, United Kingdom
  • Queen Elizabeth University Hospital
    Unverified
    Glasgow, United Kingdom
  • Cochin Hospital, Department Diabetology and Clinical Immunology Department
    Unverified
    Paris, France
  • Medical University of Graz
    Unverified
    Graz, Austria
  • UZ Leuven
    Unverified
    Leuven, Belgium
  • Diabetes centre for children and adolescents
    Unverified
    Hanover, Germany
  • I.R.C.C.S San Raffaele Hospital
    Unverified
    Milan, Italy
  • University of Siena
    Unverified
    Siena, Italy

Common questions

What is Verapamil, and why is it being studied for Type 1 diabetes?

Verapamil is a medicine usually used for high blood pressure. Scientists are studying it for Type 1 diabetes because it might help the body's pancreas make more of its own insulin, which could help manage the condition.

Who is eligible to join the Ver-A-Long study?

This study is for adults over 18 who are already participating in a previous Verapamil study (Ver-A-T1D) and whose bodies are still making a small amount of insulin.

How long will I take Verapamil in this study?

If you join, you will take Verapamil daily for 24 months, which is two years.

Will I have to go to the hospital a lot?

You'll have about 6 to 7 clinic visits over the two years, plus 4 phone calls with the study team. They're designed to check on your health and the study's progress.

Where is this study taking place?

The study is being run from the University Hospital of Wales and several other centres across the UK and Europe.

How to find out more

Colin Dayan

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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