Verapamil SR in Adults with Type 1 Diabetes (Ver-A-T1D)
Research type
Research Study
Full title
A randomised, double-blind, placebo controlled, parallel group, multi-centre trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on preservation of beta-cell function (Ver-AT1D)
IRAS ID
291503
Contact name
Alexandra Howell
Contact email
Sponsor organisation
Medical University of Graz
Eudract number
2020-000435-45
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 27 academic institutions, 4 industrial partners, a small sized enterprise and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D).
For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with Type 1 Diabetes and their families.
Type 1 diabetes (T1D) occurs when a person's own immune system attacks their insulin producing cells. When newly diagnosed, many T1D patients still have 10-20% of their insulin-producing cells still functioning.
The study is a multicenter, randomized, double-blind, placebo-controlled study in volunteers with newly diagnosed diabetes mellitus type 1 (within 6 weeks after diagnosis).The purpose of the clinical trial (Ver-A-T1D) is to confirm the effect of 360mg Verapamil sustained release (SR) administered orally once daily (titrated over the first 3 months from 120 mg to 360 mg) on the preservation of beta-cell function measured as stimulated C-peptide after 12 months compared to placebo.
The study has a cross-over design and a duration of approximately 24 months, consisting of 3 telephone visits and 7 visits at the trial site. The duration of the treatment phase with verapamil is 12 months, and an additional (optional) follow-up visit will be carried out 12 months after completion of the study. The study procedures are identical in all 20 clinical centres across Europe and the UK.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/1295
Date of REC Opinion
10 Mar 2021
REC opinion
Further Information Favourable Opinion