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Verapamil SR in Adults With Type 1 Diabetes
Sponsor: Medical University of Graz
Summary
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, 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 T1D and their families.
Official 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-A-T1D)
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2021-02-08
Completion Date
2026-05
Last Updated
2024-10-30
Healthy Volunteers
No
Conditions
Interventions
Verapamil SR 120 mg
For use as a test product in this blinded study, the IMP will be modified by re-packaging. The film-coated tablets will be squeezed from their blisters and filled into HDPE Twist-Off bottles. Each bottle will be labeled as required per country requirement. Labels will be blinded. Drug administration: * from Day 0 to Week 4: 120 mg once daily * from Week 4 to Week 8: 240 mg once daily * from Week 8 to Month 12: 360 mg once daily
Placebo
The matching placebo will be filled into HDPE Twist-Off bottles, in the same way as the verum. Each bottle will be labeled as required per country requirement. Labels will be blinded. Drug administration: * from Day 0 to Week 4: 120 mg once daily * from Week 4 to Week 8: 240 mg once daily * from Week 8 to Month 12: 360 mg once daily
Locations (22)
Medical University of Graz, Department of Internal Medicine Division of Endocrinology and Metabolism
Graz, Styria, Austria
Universitair Ziekenhuis Brussel
Brussels, Belgium
Université Libre de Bruxelles/ Hôpital Erasme
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Katholieke Universiteit Leuven
Leuven, Belgium
Institut National de la Santé et de la Recherche Médicale
Paris, France
HKA Hannover
Hanover, Germany
Universität Ulm
Ulm, Germany
Università Vita-Salute San Raffaele
Milan, Italy
Università degli Studi di Siena
Siena, Italy
Queen Elizabeth Hospital
Birmingham, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Addenbrokes Hospital
Cambridge, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
NHS Greater Glasgow and Clyde-Queen Elizabeth University Hospital, Department of Diabetes
Glasgow, United Kingdom
Bart's Hospital QMUL
London, United Kingdom
Guy's Hospital
London, United Kingdom
Queens Medical Centre
Nottingham, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
OCDEM, John Radcliffe Hospital
Oxford, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Singleton Hospital
Swansea, United Kingdom