Image-VER-A-T1D Version 1
Research type
Research Study
Full title
A GLP-1 receptor PET imaging add-on study within the Ver-A-T1D trial investigating the effects on beta cell mass (Image-VER-A-T1D)
IRAS ID
300572
Contact name
Martin Gotthardt
Contact email
Sponsor organisation
Radboud University Medical Center
Eudract number
2020-004966-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This is a multicentre imaging add-on study within the Ver-A-T1D clinical trial (2020-000435-45), which is is a multi-centre, randomised, double-blind, placebo-controlled trial in subjects with T1D within 6 weeks of diagnosis.
The purpose of the Ver-A-T1D trial 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.
30 study participants of the Ver-A-T1D trial will be included in this add-on study aiming at a 2:1 ratio (Verapamil:placebo).
The purpose of this add-on trial (Image-Ver-A-T1D) is to measure beta cell mass within the Ver-A-T1D clinical trial at the timepoints of inclusion and at evaluation after 12 months using 68Ga-NODAGA-exendin-4 PET/CT.
REC name
London - Fulham Research Ethics Committee
REC reference
22/LO/0440
Date of REC Opinion
11 Aug 2022
REC opinion
Further Information Favourable Opinion