A PET imaging substudy within the VER-AT1D trial investigating the effects on beta cell mass

A GLP-1 receptor PET imaging substudy within the VER-AT1D trial investigating the effects on beta cell mass. - PET imaging of beta cells in Type 1 diabetes, effect of verapamil (Image-Ver-A-T1D)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004966-20-FR

Enrollment

Registered

2021-10-12

Start date

2021-11-23

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes mellitus MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: 68GA-EXENDIN-NODAGA Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient: Are included in the Ver-A-T1D trial, but have not started treatment/placebo. Have given written informed consent. Age =18 years at consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: (additional to Ver-A-T1D): -Treatment with synthetic exendin (Exentide, Byetta®) or dipeptidyl-peptidase IV inhibitors (to exclude interferences with imaging), specifically mentioned although in principle part of exclusion criteria Ver-A-T1D. - Renal disease defined as MDRD < 40 ml/min/1.73m2 - Pregnancy or the wish to become pregnant within 2 month after the second PET/CT scan.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 and inter-individual differences between the treatment group and the placebo group. ;Secondary Objective: To compare changes in pancreatic 68Ga-NODAGA-exendin uptake to changes in C-peptide and proinsulin/preproinsulin measurements. To quantify the differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually for future calculations of study group sizes. ;Primary end point(s): Measure the total pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for determination of beta cell mass at the point of inclusion and after 12 months.;Timepoint(s) of evaluation of this end point: Assessment before inclusion in the Ver-A-T1D study and at the end of the study after 12 months of treatment.	—

Measure

Time frame

Main Objective: 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 and inter-individual differences between the treatment group and the placebo group. ;Secondary Objective: To compare changes in pancreatic 68Ga-NODAGA-exendin uptake to changes in C-peptide and proinsulin/preproinsulin measurements. To quantify the differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually for future calculations of study group sizes. ;Primary end point(s): Measure the total pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for determination of beta cell mass at the point of inclusion and after 12 months.;Timepoint(s) of evaluation of this end point: Assessment before inclusion in the Ver-A-T1D study and at the end of the study after 12 months of treatment.

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Secondary

Measure	Time frame
Secondary end point(s): - Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in C-peptide measurements - Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in proinsulin/preproinsulin measurements. - Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually ;Timepoint(s) of evaluation of this end point: Assessment before inclusion in the Ver-A-T1D study and at the end of the study after 12 months of treatment.	—

Measure

Time frame

Secondary end point(s): - Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in C-peptide measurements - Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in proinsulin/preproinsulin measurements. - Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually ;Timepoint(s) of evaluation of this end point: Assessment before inclusion in the Ver-A-T1D study and at the end of the study after 12 months of treatment.

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Countries

Austria, France, United Kingdom

Contacts

Public ContactPr. J-N Talbot /Scientific adviser

Assistance Publique Hôpitaux de Paris (APHP)

jean-noel.talbot@aphp.fr01 56 01 79 94

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026