Diabetes MellitusPhase 2Ver-A-imageNCT04615910
A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass
A Phase 2 study testing 68Ga-NODAGA-exendin-4 PET/CT in people with Diabetes Mellitus, run by Radboud University Medical Center at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- 68Ga-NODAGA-exendin-4 PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2021to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
- injection)
- • Must have at least one or more diabetes-related autoantibodies present at screening
- • Must have random C-peptide levels ≥200 pmol/L measured at screening
- • Be willing to comply with intensive diabetes management
Who cannot join
- Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors (to exclude interferences with imaging, specifically mentioned although in principle part of exclusion criteria of VER-A-T1D)
- Renal disease defined as MDRD <40 ml/min/1.73 m2
- Pregnancy or the wish to become pregnant within 2 months after the second PET/CT scan.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
University of Vienna
Vienna
Oana Kulterer, MD
France1 site, 1 recruiting
- Recruiting
Assistance Publique hopitaux de Paris
Paris
Jean-Noel Talbot, PhD
About this study
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.
Read the detailed description
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. Exendin, a GLP-1 receptor agonist, can be labeled with radionuclides and thus be utilized for visualization of beta cells in vivo by positron emission tomography (PET). This technology has been demonstrated to deliver quantitative information of the radiotracer uptake in the pancreas demonstrating a linear correlation with beta cell mass. In VER-A-T1D, we propose to measure beta cell mass at the time points of inclusion and at evaluation after 12 months. If verapamil protects beta cells against apoptosis, we expect that the uptake of the radiotracer will be higher at 12 months in comparison to the first measurement in the treatment group. The study will be a substudy to VER-A-T1D.
- Conditions
- Diabetes Mellitus
- Being tested
- 68Ga-NODAGA-exendin-4 PET/CT
- Keywords
- Verapamil, Type 1 Diabetes Mellitus, exendin, Beta cell mass, PET imaging
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-exendin-4 PET/CTRadiation
68Ga-NODAGA-exendin-4 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Verapamil | Experimental | Patients treated with Verapamil within the Ver-A-T1D trial Receives: Radiation: 68Ga-NODAGA-exendin-4 PET/CT |
| Placebo | Placebo comparator | Patients treated with placebo within the Ver-A-T1D trial Receives: Radiation: 68Ga-NODAGA-exendin-4 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic 68Ga-exendin uptake
the total pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for determination of beta cell mass
Measured: Change from time of inclusion to 12 months into treatment
Secondary outcomes (2)
Correlation of 68Ga-exendin uptake and C-peptide
- Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion to changes in C-peptide measurements.
Measured: 12 months into treatment
relative 68Ga-exendin uptake
- Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two timepoints of imaging intra-individually
Measured: 12 months into treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Jul 2021
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type 1 Diabetes Mellitus
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Medical University of Vienna, Bart's London, KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615910
- Sponsor's protocol ID
- 20201013
- Acronym
- Ver-A-image
- Status last verified
- Dec 2023
- First submitted
- 22 Oct 2020
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass
- ClinicalTrials.gov ID
- NCT04615910
- Acronym / sponsor ID
- Ver-A-image / 20201013
- Conditions
- Diabetes Mellitus
- Keywords
- Verapamil, Type 1 Diabetes Mellitus, exendin, Beta cell mass, PET imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Medical University of Vienna, Bart's London, KU Leuven
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Exendin, a GLP-1 receptor agonist, can be labeled with radionuclides and thus be utilized for visualization of beta cells in vivo by positron emission tomography (PET). This technology has been demonstrated to deliver quantitative information of the radiotracer uptake in the pancreas demonstrating a linear correlation with beta cell mass. In VER-A-T1D, we propose to measure beta cell mass at the time points of inclusion and at evaluation after 12 months. If verapamil protects beta cells against apoptosis, we expect that the uptake of the radiotracer will be higher at 12 months in comparison to the first measurement in the treatment group. The study will be a substudy to VER-A-T1D.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Type 1 Diabetes Mellitus
| Arm | Type | Receives |
|---|---|---|
| Verapamil | Experimental | Radiation: 68Ga-NODAGA-exendin-4 PET/CTPatients treated with Verapamil within the Ver-A-T1D trial |
| Placebo | Placebo comparator | Radiation: 68Ga-NODAGA-exendin-4 PET/CTPatients treated with placebo within the Ver-A-T1D trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • 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
- injection)
- • Must have at least one or more diabetes-related autoantibodies present at screening
Key exclusion criteria (3 listed)
- Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors (to exclude interferences with imaging, specifically mentioned although in principle part of exclusion criteria of VER-A-T1D)
- Renal disease defined as MDRD <40 ml/min/1.73 m2
- Pregnancy or the wish to become pregnant within 2 months after the second PET/CT scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-exendin-4 PET/CT68Ga-NODAGA-exendin-4 PET/CT | Radiation | Placebo, Verapamil |
Primary outcome
Pancreatic 68Ga-exendin uptake
Time frame: Change from time of inclusion to 12 months into treatment
the total pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for determination of beta cell mass
2 secondary outcomes
Correlation of 68Ga-exendin uptake and C-peptide
Time frame: 12 months into treatment
relative 68Ga-exendin uptake
Time frame: 12 months into treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-NODAGA-exendin-4 PET/CT in people with Diabetes Mellitus, run by Radboud University Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marti Boss, PhD (+31614542555, marti.boss@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic 68Ga-exendin uptake (time frame: Change from time of inclusion to 12 months into treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.