Study into the effect of treatment with Verapamil on the number of insulin-producing cells in type 1 diabetes patients (Image-Ver-A-T1D)

A GLP-1 receptor PET imaging add-on study within the Ver-A-T1D trial investigating the effects of Verapamil or placebo on beta cell mass (ImageVer-A-T1D) - Image-VER-A-T1D

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004966-20-AT

Enrollment

Registered

2021-05-07

Start date

2021-08-05

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Type 1 Diabetes MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: VeraHEXAL KHK 120 mg retard Retardtabletten Pharmaceutical Form: Coated tablet INN or Proposed INN: VERAPAMIL HYDROCHLORIDE PH. EUR. CAS Number: 52-53-9 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Have given written informed consent - Are aged between 18 and 45 years old - Are included in the VER-A-T1D trial 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: - 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 months after 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): The total pancreatic uptake of 68Ga-NODAGA-exendin for determination of beta cell mass at the point of inclusion and after 12 months.;Timepoint(s) of evaluation of this end point: After the second scan (12 months into 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): The total pancreatic uptake of 68Ga-NODAGA-exendin for determination of beta cell mass at the point of inclusion and after 12 months.;Timepoint(s) of evaluation of this end point: After the second scan (12 months into treatment)

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Secondary

Measure	Time frame
Secondary end point(s): - Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion 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 timepoints of imaging intra-individually ;Timepoint(s) of evaluation of this end point: After the second scan (12 months into treatment)	—

Measure

Time frame

Secondary end point(s): - Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion 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 timepoints of imaging intra-individually ;Timepoint(s) of evaluation of this end point: After the second scan (12 months into treatment)

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Countries

Austria, France

Contacts

Public ContactDepartment of Nuclear Medicine

Radboud University Medical Center

marti.boss@radboudumc.nl0031243613813

Outcome results

None listed

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