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Verapamil Hydrochloride Ph. Eur.

This article discusses a clinical trial investigating the use of Verapamil Hydrochloride Ph. Eur. in adults with Type 1 diabetes mellitus (T1D). The study aims to explore the long-term effects of Verapamil SR therapy on preserving beta-cell function in T1D patients. The trial is designed as an open-label, multi-centre study, focusing on various aspects of diabetes management and potential benefits of this medication.

Table of Contents

Overview of the Clinical Trial

A new clinical trial is exploring the potential benefits of a medication called Verapamil Hydrochloride for people with Type 1 diabetes mellitus (T1D). This medication, also known by its brand name Half Securon SR, is being studied to see if it can help preserve the function of beta cells in the pancreas.[1]

The trial is an open-label, multi-center study, which means that both the researchers and participants know which treatment is being given. It’s designed to look at the long-term effects of Verapamil SR therapy on adults who have been recently diagnosed with Type 1 diabetes.[1]

Purpose of the Study

The main goal of this study is to determine how Verapamil SR affects the function of beta cells in people with Type 1 diabetes. Beta cells are the cells in the pancreas that produce insulin, a hormone crucial for regulating blood sugar levels. In Type 1 diabetes, these cells are mistakenly attacked and destroyed by the body’s immune system.[1]

Specifically, the researchers want to measure:

  • Changes in beta cell function over time, measured by C-peptide response to a mixed-meal tolerance test (MMTT). C-peptide is a substance produced along with insulin and can indicate how much insulin the body is making.[1]
  • Changes in HbA1c levels, which show average blood sugar control over the past 2-3 months.[1]
  • Changes in insulin requirements over time.[1]
  • The number of severe hypoglycemic (low blood sugar) episodes and ketoacidosis (a serious complication of diabetes) episodes.[1]

Who Can Participate?

The study is looking for adults (18 years or older) who have been recently diagnosed with Type 1 diabetes. Participants must have a certain level of beta cell function remaining, as indicated by their fasting C-peptide levels.[1]

However, there are several conditions that would prevent someone from participating, including:

  • Pregnancy or plans to become pregnant during the study period[1]
  • Certain heart conditions[1]
  • Current use of beta-blockers or calcium channel blockers[1]
  • Liver or kidney problems[1]
  • Known allergy to Verapamil SR[1]

Treatment Details

Participants in the study will receive 360 mg of Verapamil SR (Half Securon SR) orally once daily for 24 months. The dose will be gradually increased over the first three weeks, starting from 120 mg and reaching the full dose of 360 mg.[1]

What Will Be Measured?

Throughout the study, researchers will measure several factors to assess the effectiveness and safety of the treatment:

  1. Beta cell function: This will be measured using a mixed-meal tolerance test (MMTT), which involves drinking a special drink and then measuring C-peptide levels in the blood.[1]
  2. Blood sugar control: HbA1c levels will be measured at regular intervals.[1]
  3. Insulin needs: The amount of insulin required daily will be tracked.[1]
  4. Safety measures: This includes monitoring vital signs, performing ECGs (heart tests), and checking laboratory safety parameters.[1]

Safety Considerations

The study will closely monitor participants for any side effects or safety concerns. This includes tracking:

  • Episodes of severe hypoglycemia (dangerously low blood sugar)[1]
  • Episodes of diabetic ketoacidosis (a serious complication where the body produces high levels of blood acids called ketones)[1]
  • Any other adverse events[1]

Potential Implications for Type 1 Diabetes Treatment

If successful, this study could open up new treatment possibilities for people with Type 1 diabetes. By preserving beta cell function, Verapamil SR might help people with T1D maintain some natural insulin production, potentially leading to better blood sugar control and reduced risk of complications.[1]

However, it’s important to remember that this is still a research study. More evidence is needed before Verapamil SR could be recommended as a standard treatment for Type 1 diabetes.[1]

Aspect Details
Study Type Open-label, multi-centre trial
Participants Adults with Type 1 diabetes mellitus
Medication Verapamil Hydrochloride Ph. Eur. (Verapamil SR)
Dosage 360 mg orally once daily
Duration 24 months
Primary Objective Assess change in beta-cell function
Secondary Objectives Monitor HbA1c changes, insulin requirements, hypoglycemic episodes, and safety
Key Measurements C-peptide response, HbA1c levels, insulin dose, adverse events

FAQ

  • What is the main goal of this clinical trial? The main goal is to determine how Verapamil SR affects beta-cell function in Type 1 diabetes patients. This is measured by looking at C-peptide response to a mixed-meal tolerance test (MMTT) at the start of the trial and after 24 months of taking 360 mg Verapamil SR once daily.
  • Who can participate in this trial? Participants must be at least 18 years old, have Type 1 diabetes, and have fasting C-peptide levels of 50 pmol/L or higher. They should have either completed or be eligible for a previous related trial called Ver-A-T1D.
  • What are some reasons why someone might not be able to participate? People who are pregnant, breastfeeding, or planning to become pregnant during the 24-month study period cannot participate. Also, those with certain heart conditions, liver or kidney problems, or those taking specific medications that might interact with Verapamil SR are not eligible.
  • How long does the trial last and what does it involve? The trial lasts for 24 months. Participants will take 360 mg of Verapamil SR orally once daily. They will undergo various tests throughout the study, including mixed-meal tolerance tests, HbA1c measurements, and insulin requirement assessments.
  • What are the potential benefits being studied? The trial is exploring whether Verapamil SR can help preserve beta-cell function in Type 1 diabetes patients. It's also looking at potential improvements in blood glucose control, changes in insulin requirements, and the safety of long-term use of Verapamil SR in T1D patients.

Ongoing Clinical Trials on Verapamil Hydrochloride Ph. Eur.

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

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Italy

Glossary

  • Type 1 diabetes mellitus (T1D): A chronic condition where the pancreas produces little or no insulin, requiring lifelong insulin therapy to manage blood sugar levels.
  • Beta-cell function: The ability of beta cells in the pancreas to produce and release insulin in response to blood sugar levels.
  • C-peptide: A substance produced along with insulin that can be measured to assess how much insulin the body is producing.
  • Mixed-meal tolerance test (MMTT): A test used to measure how well the body produces insulin in response to food intake.
  • HbA1c: A blood test that measures average blood sugar levels over the past 2-3 months.
  • Verapamil SR: A slow-release form of Verapamil Hydrochloride, a medication being studied for its potential effects on Type 1 diabetes.
  • Hypoglycemia: Low blood sugar levels that can cause symptoms like dizziness, confusion, and in severe cases, loss of consciousness.
  • Ketoacidosis: A serious complication of diabetes where the body produces high levels of blood acids called ketones.
  • Open-label trial: A type of clinical trial where both the researchers and participants know which treatment is being given.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-verapamil-hydrochloride-for-adults-with-type-1-diabetes-to-preserve-beta-cell-function/