Study on Verapamil SR for Adults with Newly Diagnosed 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 with newly diagnosed Type 1 Diabetes. Type 1 Diabetes is a condition where the body’s immune system attacks the cells in the pancreas that produce insulin, a hormone that helps control blood sugar levels. The trial aims to see if Verapamil SR, a medication usually used to treat high blood pressure, can help preserve the function of these insulin-producing cells.

Participants in the study will be randomly assigned to receive either Verapamil SR or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for 12 months, during which participants will take the medication or placebo once daily by mouth. The main goal is to observe changes in the body’s ability to produce insulin in response to food intake over this period.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the effects of the treatment. These tests will include measuring the levels of a substance called C-peptide, which indicates how well the body is producing insulin. The study will also track other health markers, such as blood sugar levels and insulin requirements, to gather comprehensive data on the potential benefits of Verapamil SR for people with Type 1 Diabetes.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of type 1 diabetes within the last six weeks and checking for specific diabetes-related antibodies.

Fasting C-peptide levels are measured to ensure they are at least 100 pmol/L.

2 randomization

Participants are randomly assigned to receive either the active medication, Verapamil SR, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 medication administration

The assigned medication, either Verapamil SR 360 mg or placebo, is taken orally once daily. This continues for the duration of the study.

4 regular monitoring

Participants undergo regular monitoring, including mixed meal tolerance tests (MMTT) at baseline, 3, 6, 9, and 12 months to measure C-peptide response.

Additional tests include monitoring of proinsulin, insulin, and other related markers, as well as tracking changes in HbA1c levels and insulin requirements.

5 safety assessments

Throughout the study, safety assessments are conducted to monitor for any severe hypoglycemic episodes or diabetic ketoacidosis.

Participants’ time in specific blood sugar ranges is also tracked using continuous glucose monitoring (CGM).

6 final evaluation

At the end of the 12-month period, a final evaluation is conducted to assess the primary endpoint, which is the change in stimulated C-peptide response.

Secondary endpoints, such as changes in HbA1c and insulin requirements, are also evaluated.

Who Can Join the Study?

Must have given written informed consent, which means you agree to participate in the study after understanding all the details.
Must be between the ages of 18 and 44 at the time of giving consent.
Must have been diagnosed with Type 1 Diabetes (T1D) within the last 6 weeks, starting from the date of your first insulin injection.
Must have at least one of the following diabetes-related autoantibodies present at screening: GADA, IA-2A, or ZnT8A. These are specific proteins in your blood that are often found in people with Type 1 Diabetes.
Must have fasting C-peptide levels of at least 100 pmol/L measured at screening. C-peptide is a substance made in the pancreas, and its level can help show how much insulin your body is making.
Must be willing to follow an intensive diabetes management plan, which means carefully managing your diabetes with the help of healthcare professionals.

Who Cannot Join the Study?

Individuals who do not have Type 1 Diabetes cannot participate. Type 1 Diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
Participants must be within a specific age range, which is not specified here, but generally means that very young children or older adults might not be eligible.
Both male and female participants are considered, so gender is not a reason for exclusion.
Participants who are part of a vulnerable population are not excluded. A vulnerable population might include groups like pregnant women or people with certain disabilities, but this study does not exclude them based on that status.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Graz	Graz	Austria
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Vrije Universiteit Brussel	Jette	Belgium
Hannoversche Kinderheilanstalt	Hanover	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Universitaetsklinikum Ulm AöR	Ulm	Germany
Institut National De La Sante Et De La Recherche Medicale	Paris	France
Abimuzg Oqnovxpfwwn Uteykvuhtlrgt Seqkzn	Siena	Italy
Ulgrernpka Ob Avfsatj	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	08.02.2021
Belgium	Not recruiting	08.02.2021
France	Not recruiting	08.02.2021
Germany	Not recruiting	08.02.2021
Italy	Not recruiting	08.02.2021

Trial locations

Investigated drugs:

Verapamil Hydrochloride

Verapamil SR is a medication being studied for its potential to help preserve the function of beta cells in people who have recently been diagnosed with type 1 diabetes. Beta cells are important because they produce insulin, which helps control blood sugar levels. In this trial, Verapamil SR is taken by mouth once a day to see if it can help maintain the body’s ability to produce insulin over time.

Investigated diseases:

Type 1 diabetes mellitus

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 it can develop in adults as well. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing 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. Managing blood sugar levels is crucial to prevent complications. Regular monitoring and lifestyle adjustments are often necessary to manage the condition effectively.

Trial ID:

2023-506545-27-01

Protocol code:

Ver-A-T1D

NCT ID:

NCT04545151

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Verapamil SR for Adults with Newly Diagnosed Type 1 Diabetes to Preserve Beta-Cell Function

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