Ver-A-Long
Research type
Research Study
Full title
An open-label extension multi-centre trial in adult subjects diagnosed with Type 1 diabetes mellitus exploring the effect of long-term Verapamil SR therapy on the preservation of beta-cell function.
IRAS ID
1010702
Contact name
Colin Dayan
Contact email
Sponsor organisation
Global Sponsor - Medical University of Graz
Eudract number
2024-515234-33
ISRCTN Number
ISRCTN49549481
Research summary
Verapamil SR is a medication that has been used for over 30 years to treat high blood pressure and is approved by both the FDA and the European Medicines Agency. It works by blocking certain calcium channels, which lowers calcium levels in cells. This action reduces the activity of a protein called TXNIP, which can negatively affect beta cells in the pancreas. By doing so, Verapamil helps the beta cells produce insulin more effectively.
Verapamil SR 360 mg will be taken once daily, with the dose gradually increased from 120 mg to 360 mg over the first 3 weeks:
- First week: 120 mg daily
- Second week: 240 mg daily
- From the third week onwards: 360 mg daily.
This 360 mg dose will be continued for the rest of the clinical trial.
Depending on the entry option, participants will have the following visits:
Option 1: A total of 10 visits – 6 clinic visits (V-1, V4-V8) and 4 telephone visits (P0, P1-P3).
Option 2: A total of 11 visits – 7 clinic visits (V-2, V-1, V4-V8) and 4 telephone visits (P0, P1-P3).
Studies in mice have shown that Verapamil can increase the number and improve the function of beta cells, potentially preventing or even reversing diabetes. Clinical trials in adults and children with newly diagnosed Type 1 Diabetes (T1D) have also shown positive results, boosting insulin production and reducing the need for insulin.
Currently, the Ver-A-T1D study is looking at how Verapamil affects adults with newly diagnosed T1D. More than 50 participants have already completed their treatment, and many more have not finished the treatment yet. Patients who are still participating in the Ver-a-T1D study now have the opportunity to take part in the Ver-A-Long study.
The goal of the Ver-A-Long study is to explore how a 24-month treatment with 360 mg of Verapamil SR helps to preserve the beta-cell function in adults with Type 1 Diabetes and to evaluate the safety of this long-term treatment.REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0103
Date of REC Opinion
18 Feb 2025
REC opinion
Further Information Favourable Opinion