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

Phase 1

• Conditions: Type 1 diabetes mellitus; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2020-004966-20-FR
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-12
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

(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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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.<br>;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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in C-peptide measurements<br>- Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in proinsulin/preproinsulin measurements.<br>- Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually<br>;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.