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ACTIVE NOT RECRUITING
NCT04545151
PHASE2

Verapamil SR in Adults With Type 1 Diabetes

Sponsor: Medical University of Graz

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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