Verapamil SR in Adults With Type 1 Diabetes

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.

Conditions

• Diabetes Mellitus, Type 1

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

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• Medical University of Graz

  lead OTHER

Principal Investigators

• Thomas R. Pieber, MD, Prof · Medical University of Graz

• Dayan Colin, MD, Prof · Cardiff University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-08

Primary Completion

2025-04-23

Completion

2026-04-17

Countries

• Austria
• Belgium
• France
• Germany
• Italy
• United Kingdom

Study Locations