A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass

What Was Tested

The trial (phase 2) is built around Exenatide.

The goal of the trial is to measure pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for detection of intra-individual differences in beta cell mass before and after treatment with Verapamil.

It had two arms (groups): Verapamil (experimental) and Placebo (placebo comparator).

Patients treated with Verapamil within the Ver-A-T1D trial.

Patients treated with placebo within the Ver-A-T1D trial.

The registry classes the interventions as radiation.

More on the Plan

The VER-A-T1D (Verapamil SR in adults with Type 1 Diabetes) study is an intervention study within the INNODIA project (an Innovative Medicines Initiative consortium (IMI-2), established through Horizon 2020 initiative of the European Union, involving academic, industry and charitable partners).

In the VER-A-T1D study, the effects of treatment of newly diagnosed patients with T1D with Verapamil will be evaluated.

Verapamil appears to protect beta cell function, an effect that could in part be caused by protection against beta cell apoptosis.

GLP-1 receptors are expressed in high densities in beta cells.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: • Have given written informed consent. • Age ≥18 and \<45 at consent. • Must have a diagnosis of T1D of within 6 weeks duration at screening (date of the first insulin. • Must have at least one or more diabetes-related autoantibodies present at screening. • Be willing to comply with intensive diabetes management.

The full record lists 7 inclusion and 3 exclusion criteria; among the exclusions: pregnancy or the wish to become pregnant within 2 months after the second pet/ct scan.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Exenatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2021-07-01 with completion listed for 2025-04-01.

It ran at 2 sites in Austria (1) and France (1).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Pancreatic 68Ga-exendin uptake (time frame: Change from time of inclusion to 12 months into treatment).

It also tracked 2 secondary outcomes, for example Correlation of 68Ga-exendin uptake and C-peptide and relative 68Ga-exendin uptake.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.