Image-Verapamil SR in Adults with Type 1 Diabetes (Image-VER-A-T1D)

Status Authorised, recruitment pending · 2 EU/EEA countries · 4 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Authorised, recruitment pending

Participants planned 30

Countries 2

Sites 4

type 1 diabetes mellitus

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.

Key facts

Sponsor: Radboud universitair medisch centrum Stichting
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Decision date (initial): 2025-01-30
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-518554-17-00
EudraCT number: 2020-004966-20
ClinicalTrials.gov: NCT04615910

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Secondary objectives 2

To compare changes in pancreatic 68Ga-NODAGA-exendin uptake to changes in C-peptide and insulin/proinsulin 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.

Conditions and MedDRA coding

type 1 diabetes mellitus

Regulatory references

Scientific advice from competent authorities: Ethikkommission Der Medizinischen Universitat Wien, Comite De Protection Des Personnes, Health Research Authority
Plan to share IPD: No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

Are included in the VER-A-T1D trial, but have not started treatment/placebo.
have given written informed consent.
Age ≥18 years at consent

Exclusion criteria 3

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The total pancreatic uptake of 68Ga-NODAGA-exendin for determination of beta cell mass at the point of inclusion and after 12 months.

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Verapamil

SCP1068778 · ATC

Active substance: Verapamil
Route of administration: ORAL
Max daily dose: 360 mg milligram(s)
Max total dose: 360 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: C08DA01 — VERAPAMIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Exenatide

SCP23185750 · ATC

Active substance: Exenatide
Substance synonyms: EXENDIN-4, LY-2148568, HIS-GLY-GLU-GLY-THR-PHE-THR-SER-ASP-LEU-SER-LYS-GLN-MET-GLU-GLU-GLU-ALA-VAL-ARG-LEU-PHE-ILE-GLU-TRP-LEU-LYS-ASN-GLY-GLY-PRO-SER-SER-GLY-ALA-PRO-PRO-PRO-SER-NH2, AC-2993
Route of administration: INTRAVENOUS BOLUS USE
Max daily dose: 100 MBq megabecquerel(s)
Max total dose: 100 MBq megabecquerel(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: A10BJ01 — EXENATIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: C-terminal modification with Lys, chelator NODAGA attached via AHX spacer for labeling with Ga-68

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Radboud universitair medisch centrum Stichting

Sponsor organisation: Radboud universitair medisch centrum Stichting
Address: Geert Grooteplein Zuid 10
City: Nijmegen
Postcode: 6525 GA
Country: Netherlands

Scientific contact point

Organisation: Radboud universitair medisch centrum Stichting
Contact name: Sevilay Tokgöz

Public contact point

Organisation: Radboud universitair medisch centrum Stichting
Contact name: Sevilay Tokgöz

Locations

2 EU/EEA countries · 4 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Authorised, recruitment pending	10	2
France	Authorised, recruitment pending	10	2
Rest of world United Kingdom	—	10	—

Investigational sites

Austria

2 sites · Authorised, recruitment pending

Medical University Of Vienna

Nuclear Medicine, Waehringer Strasse 13a, Alsergrund, Vienna

University Hospital Graz

Internal Medicine, Auenbruggerplatz 52, 8036, Graz

France