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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Hannoversche Kinderheilanstalt Hanover Germany
Ospedale San Raffaele S.r.l. Milan Italy
Institut National De La Sante Et De La Recherche Medicale Paris France
Abfxtso Obazycehzgy Upknfbjnqxnag Stocal Siena Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
02.11.2024
Belgium Belgium
Not recruiting
02.11.2024
France France
Not recruiting
02.11.2024
Germany Germany
Not recruiting
02.11.2024
Italy Italy
Not recruiting
02.11.2024

Trial locations

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.

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 ID:
2024-515234-33-00
Protocol code:
Ver-A-Long
Trial Phase:
Therapeutic exploratory (Phase II)

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